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Item 1. Business

2026-03-24 compared with 2025-03-19 · 262 added, 239 removed, 423 unchanged (54% of the section changed)

We are a pre-commercial biopharmaceutical company focused on the development and commercialization of innovative therapies to improve vision.

Our initial focus is the treatment of presbyopia, the inevitable loss of near vision that impacts the daily lives of nearly all people over 45.

In the United States, the estimated addressable population who suffer from this condition, known as presbyopes, is 128 million, almost four times the number of individuals suffering from dry eye disease and three times the number of individuals suffering from childhood myopia, macular degeneration, diabetic retinopathy and glaucoma combined.

We believe that a once-daily pharmacological eye drop that can effectively and safely improve near vision throughout the full workday, without the need for reading glasses, could be a highly attractive commercial product with an estimated U.S.

We are a commercial pharmaceutical company focused on the development and commercialization of innovative therapies to improve vision.

On July 31, 2025, the United States (“U.S.”) Food and Drug Administration (“FDA”) approved VIZZ ® (aceclidine ophthalmic solution) 1.44%, formerly known as LNZ100, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the U.S.

We are commercializing VIZZ in the U.S.

and continue to establish licensing and distribution partnerships internationally to provide access to VIZZ globally.

We believe that a once-daily pharmacological eye drop that can effectively and safely improve near vision throughout the full workday, without the need for reading glasses, is a highly attractive commercial product with an estimated U.S.

market opportunity in excess of $3 billion.

It is our goal to develop and commercialize such a product, and we have assembled an executive team with extensive clinical and commercial experience to execute this goal and become the category leader.

Our lead product candidate LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine.

We believe our product candidate is differentiated based on rapid onset, degree and duration of near vision improvement, its ability to be used across the full age range of presbyopes, from their mid-40s to well into their mid-70s, as well as a broad refractive range.

Aceclidine’s pupil-selective mechanism of action was demonstrated in our clinical trials where near vision improved while avoiding blurry distance vision.

Our product candidate was well-tolerated in clinical trials, and its active ingredient aceclidine has a favorable tolerability profile that have been well-established empirically.

LNZ100 has patent protection until 2039 in the United States, at a minimum, due to a robust intellectual property portfolio underpinned by issued patents.

In the safety and efficacy trials of our Phase 3 study (“CLARITY 1 and 2”), LNZ100 achieved the primary endpoints and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (“BCDVA”) at near, without losing one or more lines in distance visual acuity.

It is our goal to successfully commercialize VIZZ, and we have assembled an executive team with extensive clinical and commercial experience to execute this goal and become the category leader.

We commercially launched VIZZ in the U.S.

in August 2025, with direct-to-eye care professional sales and marketing activities initiated immediately upon approval.

Professional product sample distribution by the sales force to optometrists and ophthalmologists and commercial product shipments to customers via our e-pharmacy partner were initiated in October 2025, and product became broadly available in retail pharmacies beginning in November 2025.

VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours.

VIZZ is powered by aceclidine, highlighted by its differentiated mechanism of action as a predominantly pupil-selective miotic that interacts with the iris, with minimal ciliary muscle stimulation.

VIZZ contracts the iris sphincter muscle resulting in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift.

Aceclidine, the sole active ingredient in VIZZ, is a new chemical entity (“NCE”) in the U.S.

and its FDA approval marks a global first for the treatment of presbyopia.

VIZZ has patent protection until 2044 in the U.S., at a minimum, due to a robust intellectual property portfolio underpinned by issued patents.

In the safety and efficacy trials of our Phase 3 study (“CLARITY 1 and 2”), VIZZ achieved the primary endpoints and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (“BCDVA”) at near, without losing one or more lines in distance visual acuity.

In the vehicle-controlled CLARITY 2 trial, the day 1 results showed (all p<0.0001):

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Near vision improvement was reproducible and consistent across both CLARITY 1 and 2 throughout the four-week study periods.

LNZ100 was well-tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days, including the six-week safety study period in CLARITY 1 and 2, and the six-month period in the CLARITY 3 Phase 3 long-term safety trial (collectively, the “CLARITY study”).

Our other product candidate LNZ101, a preservative-free eye drop containing aceclidine and brimonidine, showed similar results, including achieving primary and secondary endpoints in both CLARITY 1 and 2, but did not show superiority to LNZ100.

Based on these results, we selected LNZ100 as our lead product candidate, for which we submitted a New Drug Application (“NDA”) to Food and Drug Administration (“FDA”) in August 2024.

In October 2024, the FDA assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of August 8, 2025, which, if approved, will be immediately followed by a commercial launch in the United States, with the product anticipated to be available in the market in the fourth quarter of 2025.

We believe that LNZ100 could be the first and only aceclidine-based product approved by the FDA and would then be eligible for five years of new chemical entity (“NCE”) exclusivity in the United States.

It is estimated that there are 1.8 billion presbyopes globally and 128 million presbyopes in the United States.

VIZZ was well-tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days, including the six-week safety study period in CLARITY 1 and 2, and the six-month period in the CLARITY 3 Phase 3 long-term safety trial (collectively, the “CLARITY study”).

It is estimated that there are 1.8 billion presbyopes globally and 128 million presbyopes in the U.S.

As people age, the crystalline lens in their eyes gradually hardens, resulting in a loss of lens elasticity that reduces the ability of the lens to increase its curvature and refractive power to focus incoming light for near vision onto the retina, known as accommodation.

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Presbyopia is typically self-diagnosed and self-managed with over-the-counter reading glasses, or managed, after evaluation by an eye care professional (“ECP”), with prescription reading or bifocal glasses or multifocal contact lenses.

Currently, the only approved and marketed pharmaceutical treatment for presbyopia is marketed by AbbVie under the brand name Vuity.

Based on data collected in a third-party study commissioned by us in early 2023 that is further described in the section “ Market Opportunity, ” we found that presbyopes have high willingness to use a daily prescription eye drop that improves their near vision throughout the full workday.

Currently, the only FDA approved and marketed pharmaceutical treatments for presbyopia are Vuity, launched by AbbVie, Qlosi, marketed by Orasis, and a generic version of Vuity, launched by Amneal Therapeutics.

In January 2026, the FDA approved Yuvezzi, which may be launched in Q2 2026 by Tenpoint Therapeutics.

improves their near vision throughout the full workday.

We expect that there will be a wide range of presbyopes that will be interested in using the eye drops at least four times a week.

The large initial demand seen for Vuity during its launch in late 2021 and early 2022 corroborates the market demand for a pharmaceutical option for the treatment of presbyopia.

However, despite a promising initial launch, Vuity’s user uptake has been limited by reportedly lower-than-expected efficacy and duration of effect across users.

Additionally, Vuity use is associated with some side effects, including rare incidences of retinal tears and detachments, induced by the stimulation of the ciliary muscle.

These limitations on efficacy and safety subsequently resulted in lower than anticipated prescription refill rates and a label amendment reflecting the risk of retinal tears and detachment specifically associated with Vuity.

We believe that our once-daily eye drop, if approved, could become the leading brand for presbyopes, by improving near vision throughout the full workday.

LNZ100 is formulated with aceclidine, a miotic, and is designed to achieve optimal pupil diameter without impacting distance vision, a key limitation of other miotics.

We believe that VIZZ will become the leading brand for presbyopes, by improving near vision throughout the full workday.

VIZZ is formulated with aceclidine, a miotic, and is designed to achieve optimal pupil diameter without negatively impacting distance vision, a key limitation of other miotics.

Miotics are compounds that cause pupil constriction, or miosis, creating a pinhole effect that enables better focus of incoming light from near objects onto the retina.

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As a result, aceclidine does not require any remaining accommodation to improve near vision, broadening its benefits to older presbyopes whose lens has lost this capacity.

Therefore, we expect that users may be able to benefit from treatment even as they age from mid-40s to well into their mid-70s and across a broad range of refractive errors, as demonstrated in clinical testing to date.

While aceclidine is new to the United States, it has a long-established history outside of the United States, having been approved in Europe since the 1970s for the treatment of glaucoma and marketed by Merck under the brand Glaucostat, at higher concentrations than in LNZ100 and up to four times a day.

Given the known favorable tolerability profile of aceclidine, LNZ100’s sole active ingredient, its decades-long use, and unique mechanism of action, we believe LNZ100 has the potential to treat the broadest population of presbyopes and become the category leader.

Given our goal to develop and commercialize the leading, once-daily eye drop for presbyopia that can effectively and safely improve near vision throughout the full workday, we continue to build a robust commercial strategy in the United States and plan to be launch-ready upon potential FDA approval.

We retain the flexibility to not only seek commercialization of our product candidates, but to also remain opportunistic in developing, in-licensing or partnering other products or product candidates to further leverage our commercial infrastructure to drive growth and operating leverage.

While aceclidine is a NCE in the U.S., it has a long-established history outside of the U.S., having been approved in Europe since the 1970s for the treatment of glaucoma and marketed by Merck under the brand Glaucostat, at higher concentrations than in VIZZ and up to four times a day.

Given the known favorable tolerability profile of aceclidine, VIZZ’s sole active ingredient, its decades-long use, and unique mechanism of action, we believe VIZZ can treat the broadest population of presbyopes and will become the category leader.

We will continue to execute our robust commercial strategy in the U.S., including our recently-launched, comprehensive direct-to-consumer marketing campaign which was initiated in Q1 2026.

We retain the flexibility to not only execute on the commercialization of VIZZ, but to also remain opportunistic in developing, in-licensing or partnering other products or product candidates to further leverage our commercial infrastructure to drive growth and operating leverage.

To execute our vision, we have assembled a team with extensive experience in building successful life science and consumer product companies.

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We have also engaged a strong team of medical advisors across the ophthalmology and optometry fields.

Our team is further supported by a strong group of investors that share our commitment to helping the millions of people experiencing symptoms of presbyopia in the United States and globally.

Our team is further supported by a strong group of investors that share our commitment to helping the millions of people experiencing symptoms of presbyopia in the U.S.

and globally.

LENZ Strategy

We are a pre-commercial biopharmaceutical company focused on the development and commercialization of innovative therapies to improve vision.

Our goal is to develop and commercialize the leading, once-daily eye drop for presbyopia that can effectively and safely improve near vision throughout the full workday.

We intend to achieve this goal by pursuing the following key strategic objectives:

• Capitalize on the unique characteristics of aceclidine through LNZ100.

We are a commercial pharmaceutical company focused on the development and commercialization of innovative therapies to improve vision.

We are commercializing VIZZ in the U.S.

and continue to establish licensing and distribution partnerships internationally to provide access to VIZZ globally, and we intend to do so by pursuing the following key strategic objectives:

• Capitalize on the unique characteristics of aceclidine through VIZZ.

A key part of our strategy was the selection and development of aceclidine as a miotic agent for the treatment of presbyopia.

As the only known pupil-selective miotic, aceclidine has a unique mechanism of action that we believe should allow for development as a category leading eye drop for presbyopia.

We have since demonstrated our ability to enable rapid onset, degree and duration of near vision improvement with minimal risk of impact to distance vision in multiple clinical

We have since demonstrated our ability to enable rapid onset, degree and duration of near vision improvement with minimal risk of having a negative impact to distance vision in multiple clinical trials, and as evidenced by real-world experience from thousands of consumers since launch.

Furthermore, we believe that aceclidine can address both a wider age range of presbyopes from mid-40s to well into their mid-70s, as well as broader refractive range, relative to currently available eye drops.

• Pursue approval and commercialization of LNZ100.

Based on our positive Phase 3 results, we selected LNZ100 as our lead product candidate.

We submitted an NDA for LNZ100 in August 2024 and in October 2024, the FDA assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of August 8, 2025.

Commercial launch is planned to immediately follow the potential approval in the United States, with the product anticipated to be available in the market in the fourth quarter of 2025.

We believe that LNZ100 could be the first and only aceclidine-based product approved by the FDA and would then be eligible for five years of NCE exclusivity in the United States.

If approved by FDA, our objective is to best create loyalty and value based on an "all eyes, all day" brand mission.

• Pursue our focused commercial strategy across U.S.

• Commercialization of VIZZ.

On July 31, 2025, the FDA approved VIZZ, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults.

The Company commercially launched VIZZ in the U.S.

in August 2025, with direct-to-eye care professional sales and marketing activities initiated immediately upon approval.

the first and only aceclidine-based product approved by the FDA.

VIZZ has five years of NCE exclusivity in the U.S., expiring in July 2030.

Our objective is to best create loyalty and value based on an "all eyes, all day" brand mission.

• Focused commercial strategy across U.S.

ECPs and presbyopes.

We are focused on targeting and partnering with the estimated 15,000 ECPs who prescribed over 85% of the pharmaceutical presbyopia prescriptions in the United States in 2022 to enable efficient commercialization and rapid adoption of our product.

We are currently educating ECPs on the importance of pupil-selective miotics that have a clinical profile that reduces pupil diameter below 2 mm without overstimulating the ciliary muscles with our EYEAMSELECTIVE campaign.

If approved, we plan to communicate the efficacy profile of the approved product and highlight the value proposition of an alternative treatment option for presbyopia for ECPs.

In parallel, our commercial team will deploy a cost-effective, highly targeted and digitally-focused consumer strategy to identify, target, and build loyalty among presbyopes in the United States.

We expect to commercialize through the self-pay healthcare market (without third-party reimbursement), which is strategically advantageous in the United States and enables immediate patient access and volume-based pricing strategies.

• Continue to build an experienced commercial team with the capabilities of a leading consumer-focused company.

We are focused on targeting and partnering with the estimated 15,000 ECPs who prescribed over 85% of the pharmaceutical presbyopia prescriptions in the U.S.

in 2022 to enable efficient commercialization and rapid adoption of our product.

Prior to FDA approval, we educated ECPs on the importance of pupil-selective miotics that have a clinical profile that reduces pupil diameter below 2 mm without overstimulating the ciliary muscles with our EYEAMSELECTIVE campaign.

Since launch, we have communicated the efficacy profile of VIZZ and highlighted the value proposition of an alternative treatment option for presbyopia for ECPs.

In parallel, our commercial team has deployed a cost-effective, highly targeted and digitally-focused consumer strategy to identify, target, and build loyalty among presbyopes in the U.S.

We are commercializing VIZZ through the self-pay healthcare market (without third-party reimbursement), which is strategically advantageous in the U.S.

and enables immediate patient access and volume-based pricing strategies.

Through the Make It VIZZable direct-to-consumer campaign, we have launched a comprehensive consumer marketing strategy to ensure patients request VIZZ by name.

• Expand our experienced commercial team with the capabilities of a leading consumer-focused company.

We have built a leadership team with extensive experience across successful life science and consumer product companies who have launched and commercialized over a dozen ophthalmic products and therapies and well-known consumer-focused brands.

Our leadership team is complemented by a team of leading medical advisors across the ophthalmology and optometry fields.

To ensure immediate commercialization upon the potential approval of LNZ100, we are timing the expansion of our existing commercial capabilities and the establishment of a sales organization of 100 to 150 individuals to coincide with the expected timing of any such approval.

We established our existing commercial capabilities and a sales organization of over 100 individuals to execute the commercial launch of VIZZ, and we have initiated the expansion of our sales organization to support growing demand and a broad prescriber base.

• Continue to strengthen our intellectual property portfolio.

We have developed and continue to expand a strong portfolio of intellectual property for the treatment of presbyopia with aceclidine-based eye drops.

We have patent protection until 2039, at a minimum, in the United States due to a robust intellectual property portfolio underpinned by issued patents.

If LNZ100 is approved, we believe that it could be the first FDA-approved aceclidine-based product and would then be eligible for five years of NCE exclusivity in the United States.

We have patent protection until 2044, at a minimum, in the U.S.

due to a robust intellectual property portfolio underpinned by issued patents.

VIZZ is the first FDA-approved aceclidine-based product and also eligible for five years of NCE exclusivity in the U.S.

We plan to actively seek to obtain, where appropriate, the broadest intellectual property protection possible by filing for additional patents or other applicable intellectual property protection covering new or enhanced proprietary technology, including new methods of use, formulations, and dosing regimens.

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• Opportunistically evaluate strategic and commercial opportunities.

We are focused on commercializing in the United States on our own.

In addition, we have entered into a license and collaboration agreement (the "CORXEL License") with CORXEL Pharmaceuticals (formerly known as Ji Xing Pharmaceuticals Hong Kong Limited) (“CORXEL”) to develop product candidates in Greater China and are developing regulatory strategies and intend to opportunistically seek partnerships for Europe, Canada, and other markets.

For more details, see the subsection entitled “License and Collaboration Agreement with CORXEL.” We believe our presbyopia program, if approved and successful, can serve as a cornerstone for building a suite of ophthalmology biopharmaceuticals.

We are focused on commercializing in the U.S.

In addition, we have entered into a license and collaboration agreement (the “CORXEL License”) with CORXEL Pharmaceuticals (formerly known as Ji Xing Pharmaceuticals Hong Kong Limited) (“CORXEL”) to develop and commercialize LNZ100 (commercially known as VIZZ in the U.S.) in Greater China, a license and commercialization agreement with Lotus Pharmaceutical Co.

(the “Lotus License”) to commercialize VIZZ in the Republic of Korea, the Kingdom of Thailand, Republic of the Philippines, the Socialist Republic of Vietnam, Malaysia, Negara Brunei Darussalam, the Republic of Indonesia, and the Republic of Singapore (collectively, “South Korea and Southeast Asia”), and Laboratoires Théa (the “Théa License”) to commercialize VIZZ in Canada.

We also entered into a distribution agreement with Lunatus Global Medical Supplies (the “Lunatus Distribution Agreement”) to sell VIZZ in a nine-country region in the Middle East, including the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Qatar, Bahrain, Oman, Jordan, Lebanon, and Iraq (collectively, the “Middle East”).

We continue to opportunistically seek partnerships for Europe, Latin America and other markets.

For more details, see the subsection entitled “Ex U.S.

License and Distribution Agreements.” We believe VIZZ can serve as a cornerstone product for building a suite of ophthalmology biopharmaceuticals.

As a result, we may acquire other products or product candidates that we believe can make a substantial impact on vision and yield high user satisfaction.

We may seek to maximize the commercial infrastructure and relationships with ECPs that we are currently building for our presbyopia program, to potentially offer a broad portfolio of ophthalmology biopharmaceuticals to our users to drive growth and operating leverage.

We may seek to maximize the commercial infrastructure and relationships with ECPs that we are currently building for VIZZ to potentially offer a broad portfolio of ophthalmology biopharmaceuticals to our users to drive growth and operating leverage.

Presbyopia is the inevitable loss of near vision associated with aging.

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Presbyopia is typically self-diagnosed and self-managed with over-the-counter reading glasses, or managed, after evaluation by an ECP, with prescription reading or bifocal glasses or multifocal contact lenses.

Currently, the only approved and marketed pharmaceutical treatment for presbyopia is marketed by AbbVie under the brand name Vuity.

In January 2026, the FDA approved Yuvezzi, which Tenpoint Therapeutics indicated may be launched in Q2 2026.

As illustrated in the figure below, contraction of the ciliary muscle allows the flexible lens in a healthy eye (center panel) to increase its curvature and refractive power and focus incoming light for near vision onto the retina in a process known as accommodation.

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Market Opportunity

Presbyopia impacts an estimated 1.8 billion people globally and 128 million people in the United States, which makes it the most prevalent ophthalmology indication, outside latent refractive errors.

Presbyopia impacts an estimated 1.8 billion people globally and 128 million people in the U.S., which makes it the most prevalent ophthalmology indication, outside latent refractive errors.

On an addressable population basis, presbyopia is almost four times greater than dry eye disease and three times greater than childhood myopia, macular degeneration, diabetic retinopathy and glaucoma combined.

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From a functional and cosmetic perspective, we see many similarities to the market dynamics between contact lenses and glasses.

The contact lens market has grown to approximately $17 billion globally and approximately $6 billion in the United States in 2022.

The contact lens market has grown to approximately $17 billion globally and approximately $6 billion in the U.S.

Contact lens users tend to have strong brand loyalty and the market has shown they are willing to spend out of pocket as an alternative to glasses for a variety of factors, including convenience, a more natural field of vision, enabling an active lifestyle and the ability to look younger.

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A prescription eye drop that can be used in combination with distance correcting lenses can allow patients to stay in their contact lenses longer.

We expect that there will be a wide range of presbyopes that will be interested in using the eye drops at least four times a week as well as a smaller group that will use them on a more episodic basis.

In early 2023, we commissioned a third-party consultant to conduct a market research study of at least 1,000 presbyopes in the United States, ranging from ages 45 to 74, through an online survey.

In early 2023, we commissioned a third-party consultant to conduct a market research study of at least 1,000 presbyopes in the U.S., ranging from ages 45 to 74, through an online survey.

The third-party consultant contacted and screened individuals who self-identified to be open to online surveys to ensure the participants satisfied the pre-specified age and near vision acuity requirements and that the group of respondents were balanced in gender and household income.

Of the individuals screened, 1,358 individuals were qualified and completed the survey, and approximately 95% indicated they would "consider" using a once-daily prescription eye drop for up to 10 hours of near vision improvement, including 60% who indicated they would “seriously consider” using such eye drop.

Of the respondents who also indicated that they would either “seriously consider” or “might consider” such eye drops, 79% indicated they would use such eye drops at least four times a week, including 58% who indicated they would use such eye drop six to seven times a week.

Furthermore, presbyopes indicated potential demand across multiple age cohorts across the following stages, including those adapting early (ages 45 to 54), busy midlife (ages 55 to 64) and active aging (ages 65+).

68% of respondents ages 45 to 54 (n=452) would “seriously consider” and another 31% “might consider” such eye drop, of which 80% (of those who would consider such eye drops) would use such eye drop at least four times a week.

For respondents ages 55 to 64 (n=448), 62% would “seriously consider” and another 31% “might consider” such eye drop, of which 79% would use such eye drop at least four times a week, and for respondents ages 65 to 74 (n=458), 51% would “seriously consider” and another 42% “might consider” such eye drop, of which 79% would use such eye drop at least four times a week.

This market survey aligns with our patient reported outcomes from our CLARITY Phase 3 study, where 75% of the 223 participants surveyed on the 28th day of receiving LNZ100 indicated interest in continuing to use the eye drops after the study, of which 81% would use the drops at least four times a week.

There is high demand for prescription eye drop-based treatments.

In 2022 alone, more than 120,000 unique users paid out-of-pocket for a prescription for Vuity, the first miotic-based eye drop approved by the FDA in late 2021.

Furthermore, survey results from participants in our CLARITY 1 & 2 clinical trials showed that 75% of participants would continue to use VIZZ after the clinical trials, of which 81% would use such eye drop at least four times a week.

We believe there is high demand for prescription eye drop-based treatments.

Furthermore, the market opportunity for presbyopia is growing due to the aging of the general population and as people continue working and stay active longer they will require effective treatment for presbyopia for near vision acuity in their daily lives.

Assuming a 6% adoption rate of the addressable presbyope patient population in the United States, we estimate there are eight million potential users in the United States for LNZ100, if approved and marketed, well below our estimate of the number of users of other out-of-pocket products such as LASIK.

Using existing market price for Vuity of $79 per prescription and assuming a 42% refill rate (or five refills in a twelve-month period), we estimate a U.S.

Assuming a 6% adoption rate of the addressable presbyope patient population in the U.S., we estimate there are eight million potential users in the U.S.

for VIZZ, well below our estimate of the number of users of other out-of-pocket products such as LASIK.

Using the price for a one-month supply of VIZZ of $79 and assuming a 42% refill rate (or five refills in a twelve-month period), we estimate a U.S.

market opportunity in excess of $3 billion.

Approaches to Manage or Treat Presbyopia and Their Limitations

Currently, the primary options available for the management of presbyopia are limited to reading glasses or multi-focal glasses and contact lenses.

The only currently FDA-approved and marketed pharmaceutical treatment for presbyopia is marketed by AbbVie under the brand name Vuity.

Prior to FDA approval of VIZZ in July 2025, the primary options available for the management of presbyopia were primarily limited to reading glasses or multi-focal glasses and contact lenses.

Currently, the only other FDA approved and marketed pharmaceutical treatments for presbyopia are Vuity, launched by AbbVie, Qlosi, marketed by Orasis, and a generic version of Vuity, launched by Amneal Therapeutics.

In January 2026, the FDA approved Yuvezzi, which Tenpoint Therapeutics indicated may be launched in Q2 2026.

Glasses and Contact Lenses

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Additionally, these products require a trade-off between near vision and distance vision, either removing the readers, or looking at different areas of the bifocals.

Eye drops can be an attractive method of treatment for presbyopia, especially when they only need to be administered once daily and effectively improve near vision throughout the full workday.

Eye drops can be an attractive method of treatment for presbyopia, especially when they only need to be dosed once daily and effectively improve near vision throughout the full workday.

Such an option can obviate the need to carry and wear reading glasses.

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Miotic agents treat presbyopia by creating a pinhole effect to increase the depth of focus and thus improve the ability to see up-close.

The pinhole effect is based on an optical effect whereby the depth of focus is inversely correlated with the size of the opening that light travels through.

The pinhole effect is based on an optical effect whereby the depth of focus is inversely correlated with the size of the

opening that light travels through.

When light passes through a small pinhole or pupil, the rays that hit the outer areas of the eye and would need the most refraction to be focused on one point of the retina are blocked, leaving only the center rays which require minimal refraction to land on the retina to form a clear image.

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Comparison of Miotics

LNZ100 is designed and formulated with aceclidine, a unique miotic, to achieve the below 2 mm pupil diameter without impacting distance vision, a key limitation seen by other miotics.

VIZZ is designed and formulated with aceclidine, a unique miotic, to achieve the below 2mm pupil diameter without negatively impacting distance vision, a key limitation seen by other miotics.

Unlike other miotics such as pilocarpine and carbachol, aceclidine’s mechanism of action is pupil-selective, meaning it can activate the iris sphincter muscle and cause miosis without overstimulating the ciliary muscles that can cause a myopic shift and impair distance vision.

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The 11 to 17 times higher independence ratio of aceclidine compared to pilocarpine reflects its pupil-selectivity.

In addition to the independence ratio, another independent, peer-reviewed, academic in vivo study 4 looked at the correlation of pupil diameter and visual distortion caused by the myopic shift of various miotics, including aceclidine at a concentration different from LNZ100, which contains 1.75% aceclidine.

The distortion is expressed in diopters ("D"), a measurement of focusing strength and distance used widely by ECPs to measure vision.

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Given that aceclidine has minimal effect on the ciliary muscle, we believe that the risk of side effects caused by activating the ciliary muscle are also reduced.

To date, the only approved and marketed pharmaceutical treatment for presbyopia is an eye drop using pilocarpine as the active ingredient that is marketed by AbbVie under the brand Vuity.

The first pharmacologic option for the treatment of presbyopia was under the brand Vuity.

Despite an initial strong commercial launch with over 120,000 unique user prescriptions filled in 2022, the refill rate has lagged, primarily due to lower-than-expected efficacy and duration.

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Therefore, we expect that older users may experience even less effect as they have little or no remaining accommodation to be activated to improve near vision, and Vuity has not been shown to reduce pupil diameter below 2mm.

Overall, the current treatment paradigm for presbyopia leaves much to be desired and is largely limited to symptom management or insufficiently effective pharmaceutical options.

Prior to the approval of VIZZ, the treatment paradigm for presbyopia has left much to be desired and was largely limited to symptom management or insufficiently effective pharmaceutical options.

Evidence from patient surveys on their experience demonstrates patient appetite for a longer-lasting and holistic solution to the treatment of presbyopia.

Our Solution:

Our lead product candidate LNZ100 is a single-use eye drop developed to restore loss of near vision associated with presbyopia.

LNZ100 contains 1.75% aceclidine as the sole active ingredient and is designed to be a once-daily dose that can potentially provide at least 10 hours of improved near vision.

LNZ100 is preservative-free enabling it to be single-use, which is a more convenient delivery method for eye drops for users, and further differentiates us from Vuity.

In our CLARITY 1 and CLARITY 2 Phase 3 trials, LNZ100 achieved its pre-specified primary endpoint of three-lines or greater improvement in BCDVA at near without losing one or more lines in distance visual acuity at three hours post-treatment, with a response rate of 71% (p<0.0001) compared to 8% for vehicle.

Based on these positive results in our Phase 3 trial, we selected LNZ100 as our lead product candidate and submitted an NDA to the FDA in August 2024.

VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours.

Aceclidine is the sole active ingredient in VIZZ and provides rapid and durable near vision improvement.

VIZZ is preservative-free and provided in single-dose vials, which is a convenient delivery method for eye drops for users.

In our CLARITY 1 and CLARITY 2 Phase 3 trials, VIZZ achieved its pre-specified primary endpoint of three-lines or greater improvement in BCDVA at near without losing one or more lines in distance visual acuity at three hours post-treatment, with a response rate of 71% (p<0.0001) compared to 8% for vehicle.

Based on these positive results in our Phase 3 trial, we selected VIZZ as our lead product candidate and submitted a New Drug Application (“NDA”) to the FDA in August 2024.

On July 31, 2025, the FDA approved VIZZ, making it the first and only aceclidine-based product approved by the FDA.

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LNZ100 CLARITY 2 - Vehicle controlled, day 1 results (n=72)

Pooled responses of LNZ100 in CLARITY 1 & 2 on day 28 (n=233)

1 CLARITY 2 - Vehicle controlled, day 1 results (n=72)

2 Pooled responses of VIZZ in CLARITY 1 & 2 on day 28 (n=233)

3 CLARITY 1, 2 & 3

We selected aceclidine, the key ingredient in LNZ100, for presbyopia because of its pupil-selective mechanism of action.

The formulation was specifically designed to achieve a below 2 mm pupil diameter without impacting distance vision, a key limitation seen with other miotic agents, such as pilocarpine and carbachol.

We selected aceclidine, the key ingredient in VIZZ, for presbyopia because of its pupil-selective mechanism of action.

The formulation was specifically designed to achieve a below 2 mm pupil diameter without negatively impacting distance vision, a key limitation seen with other miotic agents, such as pilocarpine and carbachol.

As evidenced above in the independence ratio and degree of myopic shift, aceclidine as an agent has robust clinical evidence to support the mechanism of action in achieving the key measures to both improve vision in normal and low light, while avoiding a myopic shift that impairs distance vision.

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Furthermore, aceclidine has also been used in Europe since the 1970s as an eye drop for treatment of glaucoma and was marketed by Merck under the brand name Glaucostat.

Aceclidine was previously marketed in at least twelve European countries, during which time over 400 million doses were administered up to four times a day and at higher concentrations than proposed for LNZ100, and it was well-tolerated with no known reports of tachyphylaxis, which is a sudden decrease in drug response.

Aceclidine was previously marketed in at least twelve European countries, during which time over 400 million doses were administered up to four times a day and at higher concentrations than proposed for VIZZ, and it was well-tolerated with no known reports of tachyphylaxis, which is a sudden decrease in drug response.

Aceclidine’s pupil-selective mechanism of action and reduced effect on the ciliary muscles made it a less desirable glaucoma treatment because it did not lower pressure as much as other marketed miotics.

For the same reasons, it is potentially a better treatment for presbyopia than those other miotics.

Though it has been used extensively throughout Europe, aceclidine was never commercialized in the United States, reportedly because the lyophilized, or freeze-dried,

nature of the glaucoma product presented complex supply chain issues.

Nonetheless, given aceclidine’s broad safety profile, documented through decades of commercial use in Europe, and unique mechanism of action, we believe LNZ100 has the potential to treat a broad population of presbyopes globally as they are ready-to-use, stable liquid formulations of aceclidine.

Though it has been used extensively throughout Europe, aceclidine was never commercialized in the U.S., reportedly because the lyophilized, or freeze-dried, nature of the

glaucoma product presented complex supply chain issues.

Nonetheless, given aceclidine’s broad safety profile, documented through decades of commercial use in Europe, and unique mechanism of action, we believe VIZZ has the potential to treat a broad population of presbyopes globally as they are ready-to-use, stable liquid formulations of aceclidine.

CLARITY Phase 3 Clinical Trials (the “CLARITY Study”)

In April and June 2024, we reported topline and capstone results, respectively, from the CLARITY study, a Phase 3 multi-center, double-masked, randomized, controlled, efficacy and safety study for LNZ100 and LNZ101 for the treatment of presbyopia.

The CLARITY study is comprised of three Phase 3 trials:

• CLARITY 1 (“NCT05656027”) is a six-week, multi-center, double-masked, randomized trial that evaluated the efficacy and safety of LNZ100 and LNZ101.

CLARITY 1 enrolled 469 participants, who were randomized to receive LNZ100, LNZ101 or brimonidine (at a 1:1:1 ratio) bilaterally.

• CLARITY 2 (“NCT05728944”) is also a six-week, multi-center, double-masked, randomized, Phase 3 evaluation of the efficacy and safety of LNZ100 and LNZ101 for the treatment of presbyopia.

CLARITY 2 enrolled 229 participants, who were randomized to receive LNZ100, LNZ101 or vehicle (at a 1:1:1 ratio) bilaterally.

• CLARITY 3 (“NCT05753189”) is a six-month multi-center, double-masked, randomized, Phase 3 long-term safety study of LNZ100 and LNZ101 for the treatment of presbyopia.

CLARITY 3 enrolled 361 participants, who were randomized to receive LNZ100, LNZ101 or vehicle (at a 2:2:1 ratio) bilaterally.

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CLARITY 1 & 2, 25 sites participated in CLARITY 1, 17 sites participated in CLARITY 2 and 40 sites participated in CLARITY 3

• CLARITY 1 (“NCT05656027”) is a six-week, multi-center, double-masked, randomized trial that evaluated the efficacy and safety of VIZZ and LNZ101.

CLARITY 1 enrolled 469 participants, who were randomized to receive VIZZ, LNZ101 or brimonidine (at a 1:1:1 ratio) bilaterally.

• CLARITY 2 (“NCT05728944”) is also a six-week, multi-center, double-masked, randomized, Phase 3 evaluation of the efficacy and safety of VIZZ and LNZ101 for the treatment of presbyopia.

CLARITY 2 enrolled 229 participants, who were randomized to receive VIZZ, LNZ101 or vehicle (at a 1:1:1 ratio) bilaterally.

• CLARITY 3 (“NCT05753189”) is a six-month multi-center, double-masked, randomized, Phase 3 long-term safety study of VIZZ and LNZ101 for the treatment of presbyopia.

CLARITY 3 enrolled 361 participants, who were randomized to receive VIZZ, LNZ101 or vehicle (at a 2:2:1 ratio) bilaterally.

The trials enrolled a total of 1,059 participants ranging from ages 45 to 75, and a refractive range of -4.0D SE to +1.0D SE with a baseline near visual acuity of 20/50 or worse.

Some participants had previously undergone prior vision correction, such as LASIK, or cataract extraction with lens implant (referred to as "pseudophakia").

At the first visit, the participants were randomly assigned to one of three cohorts, which determined whether the participant would be treated with LNZ100, LNZ101 or the control, which was brimonidine for CLARITY 1 and vehicle for CLARITY 2 and 3.

At the first visit, the participants were randomly assigned to one of three cohorts, which determined whether the participant would be treated with VIZZ, LNZ101 or the control, which was brimonidine for CLARITY 1 and vehicle for CLARITY 2 and 3.

Participants used their assigned treatment agent every day once-daily.

An aggregate of 234 participants in CLARITY 1 and 2 combined were assigned to use LNZ100 over the 42-day safety study period and in CLARITY 3, 144 participants assigned to use LNZ100 over the 180-day period, resulting in more than 30,000 LNZ100 treatment days across all three CLARITY trials.

An aggregate of 234 participants in CLARITY 1 and 2 combined were assigned to use VIZZ over the 42-day safety study period and in CLARITY 3, 144 participants assigned to use VIZZ over the 180-day period, resulting in more than 30,000 VIZZ treatment days across all three CLARITY trials.

The primary efficacy endpoint in both CLARITY 1 and 2 is the percentage of participants who achieve three-lines or greater improvement in BCDVA at near without losing one-line or more (5 letters or more of distance vision) at three hours post-treatment relative to control.

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Summary Trial Results

As shown in the figure below (with all p-value <0.0001), both LNZ100 and LNZ101 achieved the primary endpoint of three-lines or greater improvement in near visual acuity at three hours post-treatment, without losing one or more lines in BCDVA, in both CLARITY 1 and CLARITY 2.

In the vehicle-controlled CLARITY 2, 71% (p<0.0001) and 91% (p<0.0001) of participants receiving our lead product candidate LNZ100 achieved three- and two-lines or greater improvement, respectively, compared to 12% and 22% for vehicle on Day 1.

For the brimonidine-controlled CLARITY 1, 64% (p<0.0001) and 83% (p<0.0001) of participants receiving LNZ100 achieved three- and two-lines or greater improvement, respectively.

VIZZ achieved the primary endpoint of three-lines or greater improvement in near visual acuity at three hours post-treatment (with all p-value <0.0001), without losing one or more lines in BCDVA, in both CLARITY 1 and CLARITY 2.

In the vehicle-controlled CLARITY 2, 71% (p<0.0001) and 91% (p<0.0001) of participants who received VIZZ achieved three- and two-lines or greater improvement, respectively, compared to 12% and 22% for vehicle on Day 1.

For the brimonidine-controlled CLARITY 1, 64% (p<0.0001) and 83% (p<0.0001) of participants who received VIZZ achieved three- and two-lines or greater improvement, respectively.

In the description of the results of our clinical trials herein, p or p-values represent the probability that random chance caused the result (e.g., p<0.0001 means that there is less than a 0.01% probability that the difference between the vehicle and the treatment groups is due to random chance).

A p-value ≤ 0.05 is a commonly used criterion for statistical significance and is usually considered supportive of a finding of efficacy by regulatory authorities.

Our other product candidate LNZ101 showed similar results, including achieving primary and secondary endpoints in both CLARITY 1 and 2, but did not show superiority to LNZ100.

Vehicle-controlled CLARITY 2 Efficacy Results

LNZ100 showed rapid onset with response rates of 71% (p<0.0001), at 30 minutes post-treatment, the earliest timepoint measured, and LNZ100 maintained statistical significance of three-lines or greater improvement in near visual acuity compared to vehicle for all timepoints measured.

At 10 hours post-treatment, the last measured timepoint, 40% (p<0.0001) of users dosed with LNZ100 maintained a three-lines or greater improvement in near visual acuity compared with 5% of users dosed with vehicle.

LNZ100 also achieved the pre-specified secondary endpoint of two-lines or greater improvement in BCDVA at near without losing one or more lines in distance visual acuity at three hours post-treatment, with a response rate of 91% (p<0.0001) compared to 24% for vehicle.

LNZ100 also showed rapid onset with response rates of 91% (p<0.0001) compared to 22% for vehicle at 30 minutes post-treatment, the earliest timepoint measured, and maintained statistical significance of two-lines or greater improvement in near visual acuity compared to vehicle for all timepoints measured.

At 10 hours post-treatment, the last measured timepoint, 69% (p<0.0001) of users dosed with LNZ100 maintained a two-lines or greater improvement, compared to 21% of users dosed with vehicle.

VIZZ showed rapid onset with response rates of 71% (p<0.0001), at 30 minutes post-treatment, the earliest timepoint measured, and VIZZ maintained statistical significance of three-lines or greater improvement in near visual acuity compared to vehicle for all timepoints measured.

At 10 hours post-treatment, the last measured timepoint, 40% (p<0.0001) of users dosed with VIZZ maintained a three-lines or greater improvement in near visual acuity compared with 5% of users dosed with vehicle.

VIZZ also achieved the pre-specified secondary endpoint of two-lines or greater improvement in BCDVA at near without losing one or more lines in distance visual acuity at three hours post-treatment, with a response rate of 91% (p<0.0001) compared to 24% for vehicle.

VIZZ also showed rapid onset with response rates of 91% (p<0.0001) compared to 22% for vehicle at 30 minutes post-treatment, the earliest timepoint measured, and maintained statistical significance of two-lines or greater improvement in near visual acuity compared to vehicle for all timepoints measured.

At 10 hours post-treatment, the last measured timepoint, 69% (p<0.0001) of users dosed with VIZZ maintained a two-lines or greater improvement, compared to 21% of users dosed with vehicle.

Standard clinical practice considers two-lines or greater improvement in near visual acuity to be clinically meaningful.

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CLARITY 2, day 1 results, full analysis set.

Near visual acuity was assessed at 40cm using Monocular BCDVA (best-corrected distance visual acuity), 3-line placebo 5-12%, 2-line placebo 17-24%

We believe the clinical benefit of LNZ100 is consistent, robust and reproducible.

We believe the clinical benefit of VIZZ is consistent, robust and reproducible.

As shown in the figure below, participants experienced similar near vision improvement across the four-week study period with 81% (p<0.0001) and 82% (p<0.0001) response on Day 15 and Day 28, respectively, at 30 minutes post-treatment compared to 71% (p<0.0001) on Day 1, with 78% (p<0.0001) and 78% (p<0.0001) response on Day 15 and Day 28, respectively, at three hours post-treatment compared to 71% (p<0.0001) on Day 1, and 35% (p<0.0001) on Day 28 at ten hours post-treatment compared to 40% (p<0.0001) on Day 1.

On Day 15, no measurements were taken beyond 3 hours post-treatment.

At 10 hours post-treatment, the last measured timepoint, 69% (p<0.0001) of users dosed with LNZ100 maintained a two-lines or greater improvement, compared to 21% of users dosed with vehicle.

At 10 hours post-treatment, the last measured timepoint, 69% (p<0.0001) of users dosed with VIZZ maintained a two-lines or greater improvement, compared to 21% of users dosed with vehicle.

Standard clinical practice considers two-lines or greater improvement in near visual acuity to be clinically meaningful.

LNZ100 had no adverse impact on distance vision across all timepoints measured including 30 minutes and 1, 3, 5, 7, 8, 9 and 10 hours post-treatment in normal light conditions and 1, 3 and 10 hours in low light conditions.

In fact, at normal light, there was statistically significant improvement of two to four letters of distance vision at all time points.

VIZZ had no adverse impact on distance vision across all timepoints measured including 30 minutes and 1, 3, 5, 7, 8, 9 and 10 hours post-treatment in normal light conditions and 1, 3 and 10 hours in low light conditions.

In normal light conditions, there was statistically significant improvement of two to four letters of distance vision at all time points.

We believe these improvements are due to pupil constriction which block the peripheral light that is most likely to travel across aberrations, or nuanced distortions within the eye’s structure, and cause blurry vision.

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Pooled Safety Analysis

Across all three CLARITY trials, an aggregate of 378 participants received LNZ100.

LNZ100 was well tolerated with no drug-related serious adverse events in the more than 30,000 treatment days across all CLARITY trials.

The only reported adverse events with an incidence at 5% or more were instillation site pain, visual impairment, hyperemia and headaches.

95% of all the adverse events experienced were mild.

Of participants that reported a headache, 33% no longer experienced such transient response to installation after day 2 of product use, 44% after day 7 and 70% after day 28.

Across all three CLARITY trials, an aggregate of 378 participants received VIZZ.

VIZZ was well tolerated with no drug-related serious adverse events in the more than 30,000 treatment days across all CLARITY trials.

The only reported adverse events with an incidence over 5% were instillation site pain, visual impairment, hyperemia and headaches.

all the adverse events experienced were mild.

Of participants that reported a headache, 33% no longer experienced such transient response to instillation after day 2 of product use, 44% after day 7 and 70% after day 28.

Patient Reported Outcomes in CLARITY 1 and 2

On Day 28, each participant in CLARITY 1 and 2 completed a patient-reported outcome questionnaire regarding their experience across the prior 30 days.

90% of participants who received LNZ100 and were surveyed (n=223) indicated that they noticed improvement in near vision and 75% wished to continue to use drops after the study, of which 81% indicated that they were likely to use the drops at least four times a week.

Having successfully completed all three CLARITY trials, we submitted an NDA for LNZ100 to the FDA in August 2024 with a potential approval in mid-2025 and launch target date, if approved, in the second half of 2025.

90% of participants who received VIZZ and were surveyed (n=223) indicated that they noticed improvement in near vision and 75% wished to continue to use drops after the study, of which 81% indicated that they were likely to use the drops at least four times a week.

Having successfully completed all three CLARITY trials, we submitted an NDA for VIZZ to the FDA in August 2024, and VIZZ was subsequently approved by the FDA in July 2025.

Currently Marketed Eye Drops

On July 31, 2025, the FDA approved VIZZ, making it the first and only aceclidine-based product approved by the FDA for the treatment of presbyopia.

Vuity was approved as the first pharmaceutical treatment for presbyopia in October 2021.

Despite enthusiasm for the concept of an eye drop improving near vision throughout the full workday, Vuity’s reportedly lower than expected

efficacy, duration and adverse event profile, contributed to lower than anticipated prescription refill rates.

Despite enthusiasm for the concept of an eye drop improving near vision throughout the full workday, Vuity’s reportedly lower than expected efficacy, duration and adverse event profile, contributed to lower than anticipated prescription refill rates.

To resolve the duration issue, AbbVie tested a twice a day dosing of the same formulation following initial approval of Vuity and achieved FDA approval for this updated dosing frequency in March 2023.

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Vuity remains commercially available, but is no longer promoted.

Vuity’s FDA approval in October 2021 was based on results from two 30-day pivotal, Phase 3, randomized, double-masked, vehicle-controlled trials, GEMINI 1 and GEMINI 2.

A total of 750 participants aged 40 to 55 with presbyopia with best distance correction inclusion criteria of sphere ranging from -4.00D to +1.00D (inclusive) and cylinder ≤ ±2.00D were randomized in these two trials and patients were instructed to administer one drop of Vuity or vehicle daily in each eye.

In both trials, a statistically significant but minority portion of participants (31% of patients in GEMINI 1 and 26% of patients in GEMINI 2) showed three-lines or greater improvement in Distance Corrected Near Visual Acuity (“DCNVA”) which is equivalent to BCDVA measured at 40 centimeters, without losing more than 1 line of Corrected Distance Visual Acuity (“CDVA”) at three hours post-treatment (the last statistically significant timepoint in GEMINI 2) on Day 30.

The peak response rate at 1 hour post-treatment relative to vehicle in GEMINI 2 is 25%.

Although our CLARITY trials focused on enrolling presbyopes from ages of 45 to 75, the GEMINI trials enrolled a younger patient population ranging from ages 40 to 55 with an average age of 50 in each trial and predominantly emmetropic subjects (76% were emmetropes with sphere ranging from –0.50 D to +0.75 D and cylinder:

Moreover, data from the GEMINI 1 trial demonstrated that Vuity could not achieve a pupil diameter below 2 mm at any timepoint over the course of 10 hours post-treatment.

Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% received FDA approval in October 2023 as a once-daily treatment for presbyopia.

Like Vuity, Qlosi is a pilocarpine-based eye drop, carrying the same class-level concerns around adverse events, including the retinal detachment warning.

Commercialization

Our objective is to commercialize a product that we believe will most effectively meet the needs of the widest range of presbyopes and best create loyalty and value based on an “all eyes, all day” brand mission.

Based on the Phase 3 CLARITY results, we selected LNZ100 as our lead product candidate to prepare for commercialization and submitted an NDA in August 2024.

We are focused on commercializing in the United States on our own.

In addition, we are developing regulatory strategies and intend to opportunistically seek partnerships for Europe, Canada, and other markets.

We believe VIZZ has the unique characteristics to become the leading solution for the treatment of presbyopia, will most effectively meet the needs of the widest range of presbyopes and best create loyalty and value based on an “all eyes, all day” brand mission.

Based on the Phase 3 CLARITY results, we selected VIZZ as our lead product candidate to prepare for commercialization and submitted an NDA in August 2024.

On July 31, 2025, the U.S.

FDA approved VIZZ as the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia, and on September 30, 2025, we announced VIZZ was available to consumers.

Professional product sample distribution by our sales force to optometrists and ophthalmologists and commercial product shipments to customers via our e-pharmacy partner were initiated in October 2025, and product became broadly available in retail pharmacies beginning in November 2025.

Our primary focus is the commercial success of VIZZ in the U.S.

In addition, we are developing regulatory strategies and intend to opportunistically seek partnerships for Europe and other international markets.

In 2022, we entered into the CORXEL License to develop product candidates and products containing aceclidine and brimonidine for the treatment of patients with presbyopia in Greater China.

For more details, see the subsection entitled “License and Collaboration Agreement with CORXEL.” We are continuing to evaluate potential partnerships to pursue regulatory and commercialization in other markets.

In 2025, we entered into the Lotus License to commercialize VIZZ in South Korea and Southeast Asia, the Théa License to commercialize VIZZ in Canada, and the Lunatus Distribution Agreement to sell VIZZ in the Middle East.

For more details, see the subsection entitled “Ex-U.S.

License and Distribution Agreements.”

In March 2026, we announced the submission of a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for the review and approval of VIZZ.

If approved, the EMA’s positive opinion would serve as a foundational step toward making VIZZ available to the millions of Europeans living with age-related blurry near vision.

The submission of the MAA in Europe represents the fifth ex-U.S.

regulatory submission for VIZZ.

We are continuing to evaluate potential partnerships to pursue regulatory and commercialization globally.

Experienced Commercial Team

We plan to use the cash and cash equivalents from the Merger, the March 2024 PIPE Financing and the July 2024 PIPE Financing, in part, to continue to build the sales and marketing infrastructure required to successfully commercialize our lead product candidate in anticipation of FDA approval.

We have substantially completed hiring of all senior leadership roles in the commercial team, including adding industry veterans with extensive experience in the pharmaceutical space.

We have a well-established senior leadership team in the commercial organization, including industry veterans with extensive experience in the pharmaceutical space.

Our commercialization effort is led by our Chief Commercial Officer Shawn Olsson, who manages a team of seasoned sales and marketing executives, who have helped launch and commercialize over a dozen ophthalmic products and therapies, including Acuvue, Alphagan P, Combigan, Dailies AquaComfort Plus, Durysta, Lumigan, Pred Forte, Refresh, Restasis, Truetear, and Vuity, as well as major user-focused brands such as Botox, Dermalogica, Herbalife, Ray-Ban and Red Bull.

To ensure immediate commercialization upon the potential approval of our lead product candidate, we are timing the expansion of our existing commercial capabilities and the establishment of a sales organization of 100 to 150 individuals to coincide with the expected timing of such potential approval.

Proactive Execution of Commercial Strategy

Our commercial team has already made substantial progress in executing on our foundational commercial strategy, including selection and submission of a proprietary name, selection of an advertising agency, development of sales organization size and design, ECP segmentation and targeting, selection of a sampling vendor, selection of an e-pharmacy

partner, selection of our third-party logistics (“3PL”) provider, obtaining relevant state licensures, and setting up a customer relationship management system.

In mid-2025, we recruited and hired an 88-territory sales force, who, combined with our inside sales team, are targeting approximately 15,000 ECPs.

We continue to strategically support our sales and commercial infrastructure with capabilities designed to scale, and in Q1 2026 initiated the expansion of an additional 29 territories to our sales force, which is expected to be fully deployed in Q2 2026.

ECP-Focused Sales Strategy

We plan to launch with our own sales organization in the United States, which we envision will expand to 100 to 150 individuals.

Our strategy involves initially targeting and partnering with the estimated 15,000 ECPs who prescribed over 85% of the pharmaceutical presbyopia prescriptions in the United States in 2022.

Additionally, we will expand beyond the initial set of high-prescribing ECPs by demonstrating the unique value proposition of providing a treatment for presbyopia.

We will leverage our strong relationships with key opinion leaders to facilitate awareness regarding the importance of reducing the pupil diameter below 2 mm and using a pupil-selective miotic to avoid overstimulating the ciliary muscle.

Our sales strategy will empower ECPs to be actively involved in the diagnosis and treatment of presbyopia for the aging population, including a consumer sampling program described in “Consumer Sampling Strategy.” If our product is approved, we expect to see more ECPs begin to prescribe prescription-based eye drops, which will drive more patients requesting prescriptions who otherwise may not have sought appointments with ECPs for other eye conditions.

During 2025, we recruited and hired our own 88-territory sales force in the U.S., which we are in the process of expanding to 117 territories.

Our strategy involves initially targeting and partnering with the estimated 15,000 ECPs who prescribed over 85% of the pharmaceutical presbyopia prescriptions in the U.S.

Additionally, we have expanded beyond the initial set of high-prescribing ECPs by demonstrating the unique value proposition of providing a treatment for presbyopia.

We have leveraged our strong relationships with key opinion leaders to facilitate awareness regarding the importance of reducing the pupil diameter below 2 mm and using a pupil-selective miotic to avoid overstimulating the ciliary muscle.

Our sales strategy empowers ECPs to be actively involved in the diagnosis and treatment of presbyopia for the aging population, including a consumer sampling program described in “Consumer Sampling Strategy.” Subsequent to FDA approval and commercial launch of VIZZ, we have seen more ECPs begin to prescribe prescription-based eye drops, which will drive more patients requesting prescriptions who otherwise may not have sought appointments with ECPs for other eye conditions.

If we elect to expand our product offerings in the future, we will be able to leverage a larger community of prescribing ECPs to support product uptake.

Consumer Focused Strategy

If the NDA is approved, we also plan to deploy, in parallel, a cost-effective, highly targeted and digitally-focused consumer strategy designed to efficiently target the early adopters among the estimated 128 million presbyopes in the United States.

This will drive user awareness and interest through digital, offline, and social marketing to create brand awareness, develop brand loyalty, and eventually enable long-term brand durability and recognition.

In January 2026, we deployed a cost-effective, highly targeted and digitally-focused consumer strategy designed to efficiently target the early adopters among the estimated 128 million presbyopes in the U.S, known as the “Make it VIZZable” campaign, with award-winning actor, producer and publisher, Sarah Jessica Parker (“SJP”) as a brand ambassador for VIZZ.

As part of the campaign, SJP will detail her own experiences with age-related blurry near vision and the ways in which VIZZ has made a real difference in her life.

We anticipate this to drive user awareness and interest through digital, offline, and social marketing to create brand awareness, develop brand loyalty, and eventually enable long-term brand durability and recognition.

Our strategy involves driving consumer awareness of an effective treatment of presbyopia with prescription eye drops and creating an emotional connection to returning to life prior to presbyopia.

A key component to consumer experience is our sampling program that will provide a free option for potential users to try as described in “Consumer Sampling Strategy”.

To meet the long-term usage needs of young and old presbyopes, we plan to offer both retail access and collaborate with e-pharmacy vendors to provide easy and convenient prescription fulfillment and home delivery.

A key component to consumer experience is our sampling program that provides a free option for potential users to try as described in “Consumer Sampling Strategy.” To meet the long-term usage needs of young and old presbyopes, we offer both retail access and collaborate with our e-pharmacy partner to provide easy and convenient prescription fulfillment and home delivery.

Consumer Sampling Strategy

If the NDA is approved, we intend to establish a consumer sampling program that will be a key component to the consumer experience and reduce barriers to trial and adoption.

We believe LNZ100 is highly suitable for a consumer sampling program as users in our clinical trials have experienced rapid onset and noticeable near vision improvement after a single dose.

Our commercial team has already engaged with vendors for storage and distribution of samples to support both field representative delivery and mail delivery to ECPs.

We have established a consumer sampling program that is a key component to the consumer experience and reduce barriers to trial and adoption.

We believe VIZZ is highly suitable for a consumer sampling program as users in our clinical trials experienced rapid onset and noticeable near vision improvement after a single dose.

With in-office samples, a potential customer can try the product at the ECP’s offices or at home without having to fill a prescription.

The sampling program is a strategy for potential customers to experience near vision improvement of the product at no-cost, which can accelerate customer acceptance and desire to use the product.

If the NDA is approved, we intend to commercialize our product through the self-pay healthcare marketplace, without third-party reimbursement.

We believe pursuing a non-reimbursed product strategy will allow for strategic advantages in the United States, including immediate user access without having to negotiate with formularies and insurers, pricing and marketing flexibility, and without being subject to the Inflation Reduction Act of 2022.

The sampling program is a strategy for potential customers to experience near vision improvement of the product at no-cost, which we expect will accelerate customer acceptance and desire to use the product.

We are commercializing VIZZ through the self-pay healthcare marketplace, without third-party reimbursement.

Pursuing a non-reimbursed product strategy allowed for strategic advantages in the U.S., including immediate user access without having to negotiate with formularies and insurers, pricing and marketing flexibility, and without being subject to the Inflation Reduction Act of 2022.

Manufacturing

Our LNZ100 product candidate is a ready-to-use, self-administered, once-daily eye drop that is a formulation of aceclidine hydrochloride together with commonly used excipients.

LNZ100 is delivered via a single-use Blow-Fill-Seal (“BFS”) container and is preservative-free.

VIZZ is a ready-to-use, self-administered, once-daily eye drop that is a formulation of aceclidine hydrochloride together with commonly used excipients.

VIZZ is delivered via a single-use Blow-Fill-Seal (“BFS”) container and is preservative-free.

We do not currently own or operate facilities for manufacturing, storing, distributing or testing our product candidates and products.

We currently use different contract manufacturing organizations (“CMOs”) to supply our active pharmaceutical ingredient (“API”), aceclidine hydrochloride, and formulate and fill LNZ100, our drug product (“DP”) submitted for approval to the FDA.

All of our CMOs, including analytical and distribution chain partners, have been inspected by the FDA for compliance with current Good Manufacturing Practices (“cGMP”) regulatory guidelines.

A Drug Master File (“DMF”) is on file with the FDA for the API.

Commercial supply agreements have been secured with our API suppliers with commercially reasonable terms to meet our planned clinical and commercial activities, and we are continuing to

negotiate and enter into additional contracts for secondary supply.

Similarly, we have secured both clinical and commercial-scale supply.

Our manufacturing and testing processes are common to the pharmaceutical and ophthalmic industry, and we have identified and are working with additional API suppliers for aceclidine hydrochloride and identified secondary DP manufacturers with similar equipment for additional commercial supply.

Commercial supply agreements have been secured with our API suppliers with commercially reasonable terms to meet our commercial activities, and we have additional contracts in place for secondary supply, and have sufficient inventory and supply chain capabilities to support the launch of VIZZ.

Our manufacturing and testing processes are common to the pharmaceutical and ophthalmic industry, and we have identified and are working with additional API

suppliers for aceclidine hydrochloride and identified secondary DP manufacturers with similar equipment for additional commercial supply.

We have initiated process transfer activities for both the API suppliers and DP manufacturers.

We have completed contracting with our 3PL provider.

We expect that the 3PL provider will support cold storage commercial warehousing and distribution activities, the drug product will ship directly from the DP CMO via a qualified shipping vendor at controlled cold storage temperature to the 3PL provider, and the 3PL provider will maintain inventory and comply with the Drug Supply Chain Security Act (“DSCSA”) requirements for product serialization and track and trace capabilities.

Our 3PL provider supports cold storage commercial warehousing and distribution activities, the drug product ships directly from the DP CMO via a qualified shipping vendor at controlled cold storage temperature to the 3PL provider, and the 3PL provider maintains inventory and comply with the Drug Supply Chain Security Act (“DSCSA”) requirements for product serialization and track and trace capabilities.

The biotechnology, pharmaceutical, and ophthalmology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on intellectual property.

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However, we face competition from many different sources, including large and specialty pharmaceutical, biotechnology and ophthalmology companies, academic research institutions and governmental agencies, and public and private research institutions.

Any product candidate we develop and commercialize will have to compete with existing therapies as well as therapies currently in development and that may be developed in the future.

Any product or product candidate we develop and commercialize will have to compete with existing therapies as well as therapies currently in development and that may be developed in the future.

We believe that the key competitive factors affecting the success of any of our product candidates will include efficacy, safety profile, convenience, cost, level of promotional activity devoted to them and intellectual property protection.

As LNZ100 is being developed for the treatment of presbyopia, we may face competition from a variety of companies developing or marketing other pharmaceutical presbyopia therapies, including AbbVie (formerly Allergan), AceVision, Bausch & Lomb, Eyenovia, Glaukos, Johnson & Johnson, Orasis, OSRX Pharmaceuticals (an affiliate of Ocular Science), Viatris (through licensing of Ocuphire’s presbyopia products), Tenpoint Therapeutics, and Vyluma.

As VIZZ is marketed for the treatment of presbyopia, we may face competition from a variety of companies developing or marketing other pharmaceutical presbyopia therapies, including AbbVie (formerly Allergan), AceVision, Amneal Therapeutics, Bausch & Lomb, Eyenovia, Glaukos, Johnson & Johnson, Orasis, OSRX Pharmaceuticals (an affiliate of Ocular Science), Viatris (through licensing of Opus Genetics’ presbyopia products), Tenpoint Therapeutics, and Vyluma.

A large majority of the new pharmaceutical drops are miotic.

Other than Tenpoint which is developing a carbachol-based eye drop, most of the drops in clinical development are based on pilocarpine, similar to Vuity.

Other than VIZZ and Tenpoint, which is developing a carbachol-based eye drop, most of the drops are in clinical development or approved for use based on pilocarpine, similar to Vuity.

Many of our current or potential competitors, either alone or with their collaboration partners, have substantially greater financial resources and may have greater expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, and marketing approved products than we do.

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• marketing and product price.

We expect that any such treatment options that are successfully developed could eventually be available both within and outside the United States.

We expect that any such treatment options that are successfully developed could eventually be available both within and outside the U.S.

Consolidations and mergers and acquisitions in the pharmaceutical, medical device, and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.

Our commercial opportunity could be reduced or eliminated if our competitors develop or market products or other novel therapies that are more effective, safer, or less costly than our current or future products, or obtain regulatory approval for their products more rapidly than we may obtain approval for our products.

Our success will also be based in

part on our ability to identify, develop and manage a portfolio of products that are safer and more effective than competing therapies.

Our commercial success could be reduced or eliminated if our competitors develop or market products or other novel therapies that are more effective, safer, or less costly than our current or future products, or obtain regulatory approval for their products more rapidly than we may obtain approval for our products.

Our success will also be based in part on our ability to identify, develop and manage a portfolio of products that are safer and more effective than competing therapies.

Intellectual Property

We have developed and continue to expand our patent portfolio for the treatment of presbyopia with LNZ100.

We have developed and continue to expand our patent portfolio for our aceclidine ophthalmic product candidates, including VIZZ, for treating presbyopia, among other things.

As of December 31, 2025, we hold at least 85 issued patents.

16 of these patents are in the United States, and 28 of these patents are in other countries throughout the world, with granted patents in Australia, Brazil, Canada, China, India, Japan, Korea, Mexico, and Singapore.

17 of these patents are in the U.S., including 8 U.S.

patents covering VIZZ and methods of treating presbyopia with VIZZ, among other things.

68 of these patents are in other countries throughout the world, including 60 patents covering compositions for, and methods of treating, presbyopia with VIZZ, among other things, in countries including Australia, Brazil, Canada, China, India, Japan, Korea, Mexico, Singapore, and over thirty member states of the European Patent Organization.

These patents are expected to expire between 2034 and 2044.

Our patents cover compositions for and methods of treating presbyopia with LNZ100.

We also have at least 83 pending applications, with patent applications filed in Australia, Bolivia, Brazil, Canada, China, Europe, Hong Kong, India, Japan, Korea, Macao, Mexico, Singapore, Taiwan, the United States, Uruguay, and the Patent Cooperation Treaty system.

Patents related to LNZ100 may be eligible for patent term extensions in certain jurisdictions, including up to five years in both the United States and Europe, if granted, upon approval of commercial use of the corresponding product by a regulatory agency in the jurisdiction where the patent was granted.

No drug product containing aceclidine, an active pharmaceutical agent of LNZ100, has yet been approved in the United States under section 505(b) of the Federal Food, Drug and Cosmetic Act, for any indication.

Therefore, we believe LNZ100, if approved, could be eligible for five years of New Chemical Entity (NCE) exclusivity in the United States upon such approval so long as no other drug product containing aceclidine is approved by the FDA before approval of such product candidate.

Further, as LNZ100 has not previously been approved in Europe for any indication, LNZ100 may be eligible for eight years of data exclusivity, as well as two years of market exclusivity upon approval in Europe.

In Europe, an additional one year of exclusivity may be obtained if LNZ100 is approved for a new indication that provides a significant clinical benefit.

We also have at least 65 pending applications, with patent applications filed in Argentina, Australia, Bolivia, Brazil, Canada, China, Europe, Hong Kong, India, Japan, Korea, Macao, Mexico, Singapore, Taiwan, the U.S., Uruguay, and the Patent Cooperation Treaty system for our aceclidine ophthalmic product candidates, including VIZZ, and methods of treating presbyopia, among other things.

Patents related to VIZZ may be eligible for patent term extensions in certain jurisdictions, including up to five years in the U.S., if granted.

No other drug product containing aceclidine, an active pharmaceutical agent of VIZZ, has yet been approved in the U.S.

under section 505(b) of the Federal Food, Drug and Cosmetic Act, for any indication.

Therefore, VIZZ has five years of NCE exclusivity in the U.S., expiring in July 2030.

Further, as VIZZ has not previously been approved in Europe for any indication, VIZZ may be eligible for eight years of data exclusivity, as well as two years of market exclusivity upon approval in Europe.

In Europe, an additional one year of exclusivity may be obtained if VIZZ is approved for a new indication that provides a significant clinical benefit.

In addition to patent protection, we rely on trade secret protection and know-how to expand our proprietary position around our chemistry, technology, and other discoveries and inventions that we consider important to our business.

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We also require our employees, commercial contractors, and certain consultants and investigators, to enter into invention assignment agreements that grant us ownership of any discoveries or inventions made by them while in our employ.

License and Collaboration Agreement with CORXEL

Additionally, we have developed and continue to expand our portfolio for trademarks, including for the marks VIZZ and VIZZABLE.

As of December 31, 2025, we hold at least 47 trademark filings.

11 of these are in the U.S.

36 of these filings are in other countries throughout the world, including Australia, Brazil, Canada, China, EU, Finland, France, Germany, India, Indonesia, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Portugal, South Korea, Singapore, Spain, Sweden, Thailand, UK, and Vietnam.

License and Distribution Agreements

In addition to license agreements we have previously entered into, we continue to develop regulatory strategies and intend to opportunistically seek partnerships for Europe and other international markets to obtain regulatory approvals for, commercialize and distribute VIZZ outside of the U.S.

CORXEL License and Collaboration Agreement

In April 2022, we entered into the CORXEL License.

Under this agreement, we granted CORXEL (i) an exclusive (even as to us), royalty-bearing, nontransferable license, with the right to grant sublicenses (our prior written consent is required for sublicenses for commercialization purposes), under the technology we control including know-how and patents for CORXEL to develop, use, import and sell pharmaceutical products containing aceclidine and brimonidine for the treatment of presbyopia in humans in mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (collectively, “Greater China”), (ii) a non-exclusive, nontransferable license, with the right to grant sublicenses, under the same technology we control to manufacture the same products for the same use in Greater China, and (iii) a first right of negotiation for CORXEL to license any other product that we develop or commercialize containing aceclidine or brimonidine for uses outside of the treatment of presbyopia in Greater China.

We retain the rights to use the same technology to perform our obligations in the agreement and the non-exclusive right to manufacture and have manufactured such products in Greater China.

The agreement provides that we shall refrain from developing or commercializing any competing product, or knowingly enabling a third party to develop or commercialize a product containing aceclidine or brimonidine that would reasonably be expected to result in off-label sales of such products, for the treatment of presbyopia in humans in Greater China.

Under the terms of the agreement, we received an upfront, non-refundable payment of $15.0 million, and an investment from three funds managed or advised by RTW Investments, LP for an aggregate purchase price of approximately $10.0 million in exchange for shares of our Series A-1 preferred stock.

We are also eligible to receive an additional up to $15.0 million in development milestone payments, $80.0 million in sales milestone payments, tiered, escalating royalties in the range of 5% to 15% on net sales of such products by CORXEL, its affiliates or sublicensees in Greater China during the royalty term, and tiered, deescalating royalties in the range of 15% to 5% of CORXEL’s sublicensing income prior to the regulatory approval of the first such product in Greater China.

Royalties are subject to adjustment if no valid claim of a patent is covering such product, if a generic product exceeds 10% of the market share on a volume basis, or if a third-party license is necessary to manufacture or sell such products.

The royalty term in each region is on a product-by-product basis and the longer of (a) expiration of the last valid claim of a patent covering such product in such region, (b) expiration of regulatory exclusivity for such product in such region, and (c) ten years from the date of first commercial sale of such product in such region.

CORXEL may terminate the agreement

in its entirety at any time upon 180 days’ prior written notice.

Either party may terminate the agreement for the other’s uncured and material breach, subject to a disputed breach resolution mechanism.

Either party may also terminate the agreement upon the other party’s insolvency.

We may terminate the agreement upon 60-days’ prior written notice if CORXEL or its affiliates or sublicensees challenge the validity, enforceability, or scope of any licensed patent.

On October 27, 2024, CORXEL and the Company announced positive topline data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China.

In this China Phase 3 safety and efficacy trial, LNZ100 achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in BCDVA at near, without losing one-line or more in distance visual acuity.

Under the terms of the agreement, we received an upfront, non-refundable payment of $15.0 million, and we are also eligible to receive an additional up to $15.0 million in development milestone payments, $80.0 million in sales milestone payments, tiered, escalating royalties in the range of 5% to 15% on net sales of such products by CORXEL, its affiliates or sublicensees in Greater China during the royalty term, and tiered, deescalating royalties in the range of 15% to 5% of CORXEL’s sublicensing income prior to the regulatory approval of the first such product in Greater China.

On October 27, 2024, CORXEL and the Company announced positive topline data from the Phase 3 JX07001 clinical trial of VIZZ in patients with presbyopia in China.

In this China Phase 3 safety and efficacy trial, VIZZ achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in BCDVA at near, without losing one-line or more in distance visual acuity.

On July 28, 2025 CORXEL and the Company announced the NDA for VIZZ was submitted to the Center for Drug Evaluation of the National Medical Products Administration of the People’s Republic of China, resulting in a $5.0 million milestone

payment to the Company.

The FDA approval of VIZZ on July 31, 2025 triggered another $5.0 million milestone payment to the Company.

Lotus Pharmaceutical Co., LTD.

License and Commercialization Agreement

In May 2025, we entered into the Lotus License.

Under this agreement, we granted Lotus an exclusive license to certain of the Company's IP to commercialize VIZZ for the treatment of presbyopia in adults in the South Korea and Southeast Asia.

Under the terms of the Lotus License, the Company received a $5.0 million nonrefundable, non-creditable upfront payment, which represents the transaction price at inception, and is eligible to receive up to $120.0 million of regulatory and sales milestones, as well as tiered, escalating royalties in the range of 10% to 20% on future net sales in South Korea and Southeast Asia.

On December 1, 2025, we and Lotus announced the NDA submission to the Ministry of Food and Drug Safety for the review and approval of VIZZ, for the treatment of presbyopia in adults in South Korea.

The NDA submission was supported by positive data from three randomized, double-masked, controlled Phase 3 studies (CLARITY trials) conducted in the U.S.

Laboratoires Théa License and Commercialization Agreement

In July 2025, we entered into the Théa License.

Under this agreement we granted Théa an exclusive license to register and commercialize VIZZ for the treatment of presbyopia in adults in Canada.

Under the terms of the Théa License, we received a $2.5 million nonrefundable, non-creditable upfront payment, and are eligible to receive up to $67.5 million in regulatory and commercial milestone payments, as well as tiered, escalating royalties in the range of 10% to 20% on future net sales in Canada.

Lunatus Global Medical Supplies Distribution Agreement

In January 2026, we entered into the Lunatus Distribution Agreement.

Under this agreement, we appointed Lunatus as our exclusive distributor for the marketing and sale of VIZZ in the Middle East.

Under the terms of the Lunatus Distribution Agreement, we received a nonrefundable, non-creditable upfront payment, and are eligible to receive regulatory and commercial milestone payments and a per unit fee for each unit sold to Lunatus for distribution in the Middle East, pending regulatory approval.

Government Regulation

Our product candidates and operations are subject to extensive regulation by the Food and Drug Administration (“FDA”) and other federal and state authorities in the United States, as well as comparable authorities in other countries.

For example, our current product candidate, LNZ100, which is ophthalmic pharmaceutical product delivered through a single-use eye dropper device, is subject to regulation as drug-device combination products in the United States.

Our product and operations are subject to extensive regulation by the Food and Drug Administration (“FDA”) and other federal and state authorities in the U.S., as well as comparable authorities in other countries.

For example, VIZZ, which is ophthalmic pharmaceutical product delivered through a single-use eye dropper device, is subject to regulation as drug-device combination products in the U.S.

The FDA and other federal, state, local, and foreign authorities regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug and combination products.

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Drug Development

In the United States, the FDA regulates drugs under the Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations.

In the U.S., the FDA regulates drugs under the Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations.

Drug products and substances are subject to other federal, state and local statutes and regulations.

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Any agency or judicial enforcement action could have a material adverse effect on us.

Our lead product candidate and any future small molecule product candidates must be approved by the FDA through the new drug application (“NDA”) process before they may be legally marketed in the United States.

Any future small molecule product candidates must be approved by the FDA through the new drug application (“NDA”) process before they may be legally marketed in the U.S.

The process generally involves the following:

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• Potential FDA audit of the preclinical study and/or clinical trial sites that generated the data in support of the NDA;

• FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the United States;

• FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the U.S.;

• Compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”), and the potential requirement to conduct post-approval studies.

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Preclinical tests generally involve laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, including pharmacology, pharmacokinetics, toxicokinetic, and metabolism studies that support subsequent clinical testing in humans.

The results of the preclinical studies, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, are submitted to the FDA as part of the Investigational New Drug (“IND”) application.

An IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before clinical trials may begin.

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Sponsors are also subject to ongoing reporting requirements, including submission of IND safety reports for any serious adverse experiences associated with use of the investigational drug or findings from preclinical studies suggesting a significant risk for human subjects, as well as IND annual reports on the progress of the investigations conducted under the IND.

Clinical studies involve the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with Good Clinical Practice (“GCP”) requirements, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial.

Clinical studies involve the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial.

Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety and assess efficacy.

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National Institutes of Health, ClinicalTrials.gov.

A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND.

A sponsor who wishes to conduct a clinical trial outside of the U.S.

may, but need not, obtain FDA authorization to conduct the clinical trial under an IND.

If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical trial to the FDA in support of an NDA.

The FDA will generally accept a well-designed and well-conducted foreign clinical trial not conducted under an IND if the trial was conducted in accordance with GCP requirements and the FDA is able to validate the data through an onsite inspection if deemed necessary.

Clinical trials in the United States generally are conducted in three phases, known as Phase 1, Phase 2, and Phase 3.

Clinical trials in the U.S.

generally are conducted in three phases, known as Phase 1, Phase 2, and Phase 3.

Although the phases are usually conducted sequentially, they may overlap or be combined.

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Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee.

This group provides authorization for whether a trial may move forward at designated check-points based on access to certain data from the trial.

This group provides authorization for whether a trial may move forward at designated

check-points based on access to certain data from the trial.

Concurrent with clinical trials, companies usually complete additional animal safety studies and also must develop additional information about the chemistry and physical characteristics of the drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

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To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of the FDA.

FDA approval of an NDA must be obtained before a drug may be marketed in the United States.

FDA approval of an NDA must be obtained before a drug may be marketed in the U.S.

Under the Prescription Drug User Fee Act, as amended (“PDUFA”), each NDA must be accompanied by an application user fee.

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The FDA may refer applications for novel drug products or products which present difficult questions of safety or efficacy to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions.

Of note, the FDA notified the Company in its letter to notify its acceptance to review the NDA that they do not plan to hold an advisory committee meeting, which was reiterated during the mid-cycle review.

Before approving an NDA, the FDA typically will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMP requirements.

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After approval, if there are any changes to the approved product, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require the development of additional data or preclinical studies and clinical trials.

There also are continuing user fee requirements, under which FDA assesses an annual program fee for each product identified in

an approved NDA.

There also are continuing user fee requirements, under which FDA assesses an annual program fee for each product identified in an approved NDA.

In addition, quality control, drug manufacture, packaging, and labeling products must continue to conform to cGMP requirements after approval.

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Failure to comply with the applicable regulatory requirements at any time during the product development process, approval process or after approval may subject an applicant or manufacturer to, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties.

mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties.

FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, clinical hold, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties.

Regulation of Drug/Device Combination Products

We expect LNZ100 to be subject to regulation in the United States as a combination product comprised of a drug product candidate and a device delivery system.

VIZZ is subject to regulation in the U.S.

as a combination product comprised of a drug product and a device delivery system.

A combination product is the combination of two or more regulated components, such as a drug/device, that are combined or mixed and produced as a single entity, packaged together in a single package or a drug or device packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug or device where both are required to achieve the intended use, indication or effect.

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The Office of Combination Products will review the request and make its jurisdictional determination within 60 days of receiving a Request for Designation.

For LNZ100, which is an ophthalmic pharmaceutical product prefilled and packaged in a single-use eye dropper device, the mechanism of action and the pharmacological effect are attributable to the drug component of the drug-device combination product.

Consistent with our communications with FDA to date and the regulatory pathway for other ophthalmic pharmaceutical products, we submitted an NDA for LNZ100 in August 2024, and we do not expect that the FDA will require a separate marketing authorization for the device component.

However, each component of LNZ100 will need to meet the applicable quality and manufacturing standards set by FDA, meaning the drug product must be manufactured in accordance with GMPs for drugs, and the device component must be manufactured in a manner consistent with the device GMPs set forth in FDA’s Quality Management System Regulation, as amended.

For VIZZ, which is an ophthalmic pharmaceutical product prefilled and packaged in a single-use eye dropper device, the mechanism of action and the pharmacological effect are attributable to the drug component of the drug-device combination product.

Consistent with our communications with FDA to date and the regulatory pathway for other ophthalmic pharmaceutical products, we submitted an NDA for VIZZ in August 2024, and the FDA did not require a separate marketing authorization for the device component.

However, each component of VIZZ needs to meet the applicable quality and manufacturing standards set by FDA, meaning the drug product must be manufactured in accordance with GMPs for drugs, and the device component must be manufactured in a manner consistent with the device GMPs set forth in FDA’s Quality Management System Regulation, as amended.

Patent-Term Restoration and Marketing Exclusivity

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The patent term restoration period is generally one-half the time between the effective date of an IND or the issue date of the patent, whichever is later, and the submission date of an NDA plus the time between the submission date of an NDA or the issue date of the patent, whichever is later, and the approval of the NDA application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence.

Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent.

Only one patent applicable to an approved

drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent.

The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.

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Market exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications.

The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity.

A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance.

The FDCA provides a five-year period of non-patent marketing exclusivity within the U.S.

to the first applicant to gain approval of an NDA for a NCE.

A drug is a NCE if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance.

During the exclusivity period, the FDA may not approve an abbreviated new drug application (“ANDA”), or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.

However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement.

The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than

bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, new indications, dosages or strengths of an existing drug.

This three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent.

The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, new indications, dosages or strengths of an existing drug.

This three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving NDAs for drugs containing the original active agent.

Such three-year and five-year exclusivity will not delay the submission or approval of a full NDA.

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Regulatory Matters

Although we do not expect any of our products, if approved, would be covered by any government healthcare programs or other third-party payors, we may still be subject to state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including self-pay patients;

Although VIZZ is not covered by any government healthcare programs or other third-party payors, we may still be subject to state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including self-pay patients;

state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers;

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Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions or safe harbors, it is possible that some of our activities could be subject to challenge under one or more of such laws.

The growth of our business and sales organization and our expansion outside of the United States may increase the potential of violating these laws or our internal policies and procedures.

The growth of our business and sales organization and our expansion outside of the U.S.

may increase the potential of violating these laws or our internal policies and procedures.

The risk of us being found in violation of these or other laws and regulations is further increased by the fact that many have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to various interpretations.

Any action brought against us for violations of these laws or regulations, even successfully defended, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

If our operations are found to be in violation of any of the federal, state and foreign laws described above or any other current or future fraud and abuse or other healthcare laws and regulations that apply to us, we may be subject to penalties, including significant civil, criminal and administrative penalties, including damages, fines, disgorgement, individual imprisonment, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, injunctions, requests for recall, seizure of products, total or partial suspension of production, denial or withdrawal of product approvals or refusal to allow a firm to enter into supply contracts, including government contracts, and we could be required to curtail or cease our operations.

and we could be required to curtail or cease our operations.

Any of the foregoing consequences could seriously harm our business and our financial results.

Healthcare Reform

Although we do not expect any of our products, if approved, would be covered by any government healthcare programs or other third-party payors, legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

Although VIZZ is not covered by any government healthcare programs or other third-party payors, legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

We cannot be sure whether additional legislative changes will be enacted, or whether FDA or other agency regulations, guidance or interpretations will be changed, or what the impact of such changes on the regulatory approvals of our product candidates, if any, may be.

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Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous.

interpretations of market exclusivities and the “substantial evidence” requirements for drug approvals, which could undermine FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions.

Further, changes in the leadership of the FDA and other federal agencies under the Trump administration may lead to new policies and changes in the regulations, which may impact our clinical development plans.

This landmark Supreme Court decision may invite various stakeholders to bring lawsuits against the FDA or other agencies to challenge longstanding decisions and policies of the FDA, including FDA’s statutory interpretations of market exclusivities and the “substantial evidence” requirements for drug approvals, which could undermine FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions.

Further, changes in the leadership of the FDA and other federal agencies may lead to new policies and changes in the regulations, which may impact our commercial strategy.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future litigation, legislation or administrative or executive action, and their impact on our business and the pharmaceutical industry as a whole.

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In addition, different pricing and reimbursement schemes exist in different countries.

In the United States, federal and state governments have become increasingly active in implementing regulations designed to control pharmaceutical product pricing.

In the U.S., federal and state governments have become increasingly active in implementing regulations designed to control pharmaceutical product pricing.

Cost-containment measures on prescription drugs and alternative treatment options covered and reimbursed by payors could exert a downward pressure on the pricing of other treatment options, even if not covered or reimbursed by payors.

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There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products.

Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to be significantly lower.

For more information, see the section titled “Risk Factors—Risks Related to Our Company—we may face difficulties from changes to current regulations and future legislation.

Historically, products launched in the European Union do not follow price structures of the U.S.

and generally prices tend to be significantly lower.

For more information, see the section titled “Risk Factors—Risks Related to Our Company—we may face difficulties from changes to current regulations and future

Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.”

Foreign Regulation

In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our product candidates to the extent we choose to develop or sell any product candidates outside of the United States.

In addition to regulations in the U.S., we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our product candidates to the extent we choose to develop or sell any product candidates outside of the U.S.

The approval process varies from country to country and the time may be longer or shorter than that required to obtain FDA approval.

1 unchanged sentence

Employees and Human Capital Resources

As of December 31, 2024, we had 42 employees, 21 of whom were engaged in research and development activities.

As of December 31, 2025, we had 152 employees, none of whom were engaged in research and development activities.

We also engage contractors and consultants.

19 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business