What changed in this filing

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Item 1. Business

2025-04-15 compared with 2024-03-18 · 179 added, 211 removed, 781 unchanged (33% of the section changed)

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On October 6, 2014, we reincorporated in the State of Delaware by merging into Eyenovia, Inc., a Delaware corporation.

Our principal executive office is located at 295 Madison Avenue, Suite 2400, New York, NY 10017, and our phone number is (833) 393-6684.

Our principal executive office is located at 23461 South Pointe Drive, Suite 390, Laguna Hills, CA 92653, and our phone number is (833) 393-6684.

Our website is www.eyenovia.com .

Information contained on, or that can be accessed through, our website is not incorporated by reference into this report, and you should not consider information on our website to be part of this report.

We are an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine HCL ophthalmic spray) for inducing mydriasis for routine diagnostic procedures and in conditions where short term pupil dilation is desired, preparing for the commercialization of clobetasol propionate ophthalmic suspension 0.05% (“clobetasol propionate”), for the treatment of post-operative inflammation and pain following ocular surgery, and developing the Optejet® delivery system both for use in combination with our own drug-device therapeutic programs and for out-licensing for use in combination with therapeutics for additional indications.

Our aim is to improve the delivery of topical ophthalmic medication through the ergonomic design of the Optejet which facilitates ease-of-use and delivery of a more physiologically appropriate medication volume, with the goal to reduce side effects and improve tolerability, and introduce digital health technology to improve therapy compliance and ultimately medical outcomes.

We are an ophthalmic technology company developing our proprietary Optejet® topical ophthalmic medication dispensing platform.

In November 2024, we received a negative clinical trial result in the development of our development-stage drug-device combination product, MicroPine.

As a result, we restructured our company to minimize expenses and engaged an investment bank to explore strategic options in order to maximize shareholder value.

We have paused the national sales roll-out of our products clobetasol propionate and Mydcombi® until additional funding is obtained.

At the same time, we accelerated our development efforts relating to the Optejet in order to potentially increase the value of that asset in any strategic transaction or capital raising activities.

The ergonomic and functional design of the Optejet allows for horizontal drug delivery and eliminates the need to tilt the head back or the manual dexterity to squeeze a bottle to administer medications.

Drug is delivered in a microscopic array of droplets faster than the blink reflex to help ensure instillation success.

The precise delivery of a low-volume columnar spray by the Optejet device minimizes contamination risk with a non-protruding nozzle and self-closing shutter.

In clinical trials, the Optejet has demonstrated that its targeted delivery achieves a high rate of successful administration, with 98% of sprays being accurately delivered upon first attempt compared to the established rate reported with traditional eye drops of ~ 50%.

A more physiologically appropriate volume of medication in the range of seven to nine microliters is delivered by the Optejet, which is approximately one - fifth of the 35 to 50 microliter dose typically delivered in a single eye drop.

Lower volume of medication exposes the ocular surface to less active ingredient and preservatives, potentially reducing ocular stress and surface damage and improving tolerability.

Drug is delivered in a microscopic array of droplets that is both comfortable and matches the amount of fluid that the front of the eye can hold.

The precise delivery of a low-volume columnar spray by the Optejet device helps ensure instillation success while minimizing contamination risk with a non-protruding nozzle and self-closing shutter.

A more physiologically appropriate volume of medication in the range of seven to ten microliters is delivered by the Optejet, which is approximately one-fifth of the 35 to 50 microliter dose typically delivered in a single eye drop.

Lower volume of medication exposes the ocular surface to less active ingredients and preservatives, potentially reducing ocular stress and surface damage and improving tolerability.

The lower volume also minimizes the potential for drug to enter systemic circulation, with the goal of avoiding some common side effects that are related to overdosing of the eye.

We are developing versions of the Optejet with on-board digital technology that records the date and time of each use.

These data may be used to provide reminders via Bluetooth to smart devices and to allow healthcare practioners to monitor usage.

These data may be used to provide reminders via Bluetooth to smart devices and to allow healthcare practitioners to monitor usage.

This information can then be used by practitioners and health care systems to measure treatment compliance and improve medical decision making.

In this way, the Optejet could serve as an extension of the physician’s office by providing information that is not currently possible to collect except through the use of diaries.

Our drug-device product line includes Mydcombi (tropicamide and phenylephrine HCL ophthalmic spray), clobetasol propionate, and therapeutic programs MicroPine (atropine ophthalmic spray) and MicroLine (pilocarpine ophthalmic spray).

MicroPine is our first-in-class topical therapy for the treatment of progressive myopia, a disease associated with pathologic axial elongation of the eye and sclero-retinal stretching.

In the United States, myopia is estimated to affect approximately 25 million children, with up to five million considered to be at high risk for progressive myopia.

In February 2019, the FDA accepted our Investigational New Drug application (“IND”) to initiate the CHAPERONE study to reduce the progression of myopia in children.

The first patient was enrolled in the CHAPERONE study in June 2019.

MicroLine is our investigational pharmacologic treatment for presbyopia, a non-preventable, age-related hardening of the lens, which causes the gradual loss of the eye’s ability to focus on near objects and impairs near visual acuity.

We have completed two Phase III studies using our Optejet device.

In these studies, patients reported high satisfaction with using the device, and a strong preference over using an eye dropper bottle.

Since completing these studies, the market opportunity has markedly deteriorated, and we have chosen to put this program on hold and reallocate our resources towards larger opportunities.

When and if the market improves, we have kept open the option to continue development of MicroLine, which would include a meeting with the U.S.

Food and Drug Administration (the “FDA”) to review our clinical data to date.

Our first product using the Optejet technology, Mydcombi®, is the only FDA-approved fixed combination of the two leading mydriatic agents, tropicamide and phenylephrine, in the United States.

As an ophthalmic spray delivered with Optejet technology, Mydcombi may present a number of benefits for ophthalmic surgical centers, optometric and ophthalmic offices and patients.

Those benefits may include improved cost-effectiveness in centers that employ single-use bottles for mydriasis, more efficient use of office time and resources, and an overall improved doctor-patient experience.

The first commercial sale of Mydcombi occurred on August 3, 2023 as part of a targeted launch, and we expanded our launch with the hiring and onboarding of ten sales representatives through December 31, 2024.

On July 24, 2024, we received written comments

from the FDA providing direction for the design of a clinical bridging study to transition Mydcombi into our new Gen-2 Optejet device, which has a significantly lower cost to manufacture than the currently approved product.

On August 10, 2020, we entered into a license agreement with Arctic Vision (as amended on September 14, 2021, the “Arctic Vision License Agreement”) pursuant to which Arctic Vision may develop and commercialize MicroPine (Eyenovia’s proprietary drug-device combination of low-dose atropine and the Optejet platform), MicroLine and Mydcombi in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.

Under the terms of the Arctic Vision License Agreement, as amended, we received an upfront payment of $4.25 million before any payments to Senju Pharmaceutical Co., Ltd.

On October 9, 2020, we entered into a license agreement (the “Bausch License Agreement”) with Bausch + Lomb (“B+L”), pursuant to which B+L had the rights to develop and commercialize MicroPine in the United States and Canada.

Under the terms of the Bausch License Agreement, we received an upfront payment of $10.0 million and we were eligible to receive up to a total of $35.0 million in additional payments, based on the achievement of certain regulatory and launch-based milestones.

B+L also agreed to pay royalties to Eyenovia on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from sales of MicroPine

in the United States and Canada, subject to certain adjustments.

Under the terms of the Bausch License Agreement, B+L assumed sponsorship of the IND as well as ownership and the costs related to the ongoing CHAPERONE study.

B+L also agreed to pay royalties to Eyenovia on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from sales of MicroPine in the United States and Canada, subject to certain adjustments.

Under the terms of the Bausch License Agreement, B+L assumed sponsorship of the IND as well as ownership and the costs related to the ongoing CHAPERONE study, which was a Phase III efficacy and safety trial of MicroPine.

On January 12, 2024, we entered into a subsequent agreement with B+L to repatriate our rights to MicroPine and take control of the CHAPERONE study.

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We also agreed to pay B+L a 2% royalty on net sales once MicroPine is commercialized in the United States, assuming receipt of regulatory approvals.

We believe that this new arrangement is in our and our shareholders’ best interests, as it may substantially increase the value of the asset significantly through potential improvements in the conduct of the study, including a planned interim analysis of the data in late 2024.

We have also successfully expanded our manufacturing capabilities through a partnership with Coastline International, Inc.

We believed that this revised arrangement was in our and our shareholders’ best interests, as it could have substantially increased the value of the asset through potential improvements in the conduct of the study, including a planned interim analysis of the data in late 2024.

On September 26, 2024, we announced the U.S.

launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%.

On November 15, 2024, we announced the outcome of an independent review of the clinical results of the three-year efficacy and safety data from the MicroPine Phase III CHAPERONE study conducted by a Data Monitoring Committee (“DMC”).

The DMC, made up of independent ophthalmologists and optometrists who specialize in pediatric myopia as well as a statistician, reviewed the safety and efficacy data from all evaluable patients.

After the completion of three-year therapy for myopia with MicroPine, statistical superiority was not observed and was deemed unlikely to occur in at least one of the active dose arms compared with placebo, which was the primary efficacy endpoint of the trial.

There were no safety issues or serious adverse events identified.

As a result of this finding, we closed out the CHAPERONE study and put the project on hold in December 2024.

In light of the results from the CHAPERONE study, the Company is considering a variety of steps to maximize value to all stakeholders, to reduce expenses and to evaluate its strategic options, which may include a business combination, reverse merger, asset sales or a combination of those alternatives.

Further information will be made available once the evaluation of strategic options has been completed.

The Company implemented a reduction in force affecting approximately 75% of its workforce.

The estimated total cost of severance-related expenses relating to this reduction in force is $0.3 million.

The remaining staff will be focused on Optejet® Gen-2 development, our dry eye collaborations and clobetasol propionate commercialization.

We successfully expanded our manufacturing capabilities through a partnership with Coastline International, Inc.

located in Tijuana, Mexico, as well as the construction of our new manufacturing facility in Reno, Nevada and the construction of our own fill and finish facility in Redwood City, California.

We have received FDA clearance for using both Coastline International and our Redwood City facility for the production of Mydcombi cartridges, and FDA clearance for using our Reno facility for the production of technical elements such as the base unit for the Optejet device.

There are two FDA-approved treatments for presbyopia which use pilocarpine, the same drug used in our investigational product.

We have completed two Phase III studies using our Optejet® device.

In these studies, patients reported high satisfaction with using the device, and a strong preference over using an eye dropper bottle.

We released positive top-line results from VISION-2 in the fourth quarter of 2022.

We are now planning to meet with the FDA in mid-2024 to discuss a transition of the product to our new Gen-2 Optejet device, which has a significantly lower cost to manufacture than the first generation device.

Mydcombi is our fixed combination formulation of tropicamide-phenylephrine for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.

Mydcombi is a novel approach for the over 106 million office-based comprehensive and diabetic eye exams and 7 million ocular surgeries performed every year in the United States.

As the only FDA-approved fixed combination of the two leading mydriatic agents in the United States and as an ophthalmic spray, Mydcombi may present a number of benefits for ophthalmic surgical centers, optometric and ophthalmic offices and patients.

We are currently commercializing the product starting with a targeted launch and continuing to expand during 2024, when we expect our ten sales representatives and internal manufacturing capabilities to come on-line.

On August 10, 2020, we entered into a license agreement with Arctic Vision (as amended on September 14, 2021, the “Arctic Vision License Agreement”) pursuant to which Arctic Vision may develop and commercialize MicroPine, MicroLine and Mydcombi in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.

Under the terms of the Arctic Vision License Agreement, as amended, we received an upfront payment of $4.25 million before any payments to Senju Pharmaceutical Co., Ltd.

In addition, we may receive up to a total of $37.7 million in additional payments, based on various development and regulatory milestones, including the initiation of clinical research and approvals in Greater China and South Korea, and development costs.

Arctic Vision also will purchase its supply of MicroPine, MicroLine and Mydcombi from Eyenovia or, for such products not supplied by Eyenovia, pay a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments.

We will pay between 30 and 40 percent of such payments, royalties, or net proceeds of such supply to Senju pursuant to an exclusive license agreement with Senju dated March 8, 2015, as amended (the “Senju License Agreement”).

In addition to our own development programs, on August 15, 2023, we entered into a license agreement (the “License”) with Formosa Pharmaceuticals Inc.

The FDA approved the use of both Coastline International and our Redwood City facility for the production of Mydcombi cartridges, and the use of our Reno facility for the production of technical elements such as the base unit for the Optejet device.

As part of the Company’s steps to maximize value to all stakeholders, to reduce expenses and to evaluate its strategic options, we made the decision to phase out the production and sale of Mydcombi in the GEN-1 device.

As a result, we have phased out the manufacturing line at Coastline International, Inc.

located in Tijuana, Mexico, and are also modifying the use of our manufacturing facility in Reno, Nevada and our fill and finish facility in Redwood City, California to focus on Optejet® Gen-2 development, our dry eye collaborations and clobetasol propionate commercialization.

In addition to our own development programs, on August 15, 2023, we entered into a license agreement with Formosa Pharmaceuticals, Inc.

(“Formosa”), whereby we acquired the exclusive U.S.

rights to commercialize any product related to a novel formulation of clobetasol propionate, which was approved by the U.S.

Food and Drug Administration (“FDA”) on March 4, 2024.

On March 13, 2024, the NDA for the product was transferred from Formosa to Eyenovia.

The License will remain in effect for ten years from the date of the first commercial sale of clobetasol propionate, unless earlier terminated.

We paid Formosa an upfront payment in an aggregate amount of $2,000,000 which consisted of (a) cash in the amount of $1,000,000 and (b) 487,805 shares of common stock valued at $1,000,000.

We also capitalized $122,945 of transaction costs in connection with the License.

In addition, we must pay Formosa up to $4 million upon the achievement of certain development milestones and up to $80 million upon the achievement of certain sales milestones.

We are in active discussions with manufacturers of existing and late-stage ophthalmic medications to explore whether development with the Optejet technology can solve unmet medical and business needs.

Some of those business needs could include extension of exclusivity under the Optejet patents, improvement in a drug’s tolerability profile, or potential improvement in treatment compliance.

The following summarizes our product pipeline and anticipated milestones:

Product or Product

Next Expected Milestones

Pharmaceutical Mydriasis (Pupil Dilation)

Commercial Launch Underway

Clobetasol Propionate

Post Ocular Surgery Pain and Inflammation

Commercial Launch Pending

Improvement in Near Vision (Presbyopia)

Pre-NDA Meeting Mid-2024

Pediatric Myopia Progression (Near-Sightedness)

Phase III CHAPERONE Ongoing;

Planned Phase III Interim Analysis Q4 2024

Our goal is to become a leading developer and provider of advanced ophthalmic therapies based upon our microdose array print (MAP) platform technology and digital health platform for interactive patient care.

These unique products would be commercialized by us and/or our partners globally.

rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic suspension 0.05% (the “Formosa Licensed Product”), which was approved by the FDA, for post-operative inflammation and pain after ocular surgery, on March 4, 2024.

The Formosa License will remain in effect for ten years from the date of the first commercial sale of a Formosa Licensed Product, unless earlier terminated.

We paid Formosa an upfront payment in an aggregate amount of $2.0 million which consisted of (a) cash in the amount of $1.0 million and (b) 487,805 shares of common stock valued pursuant to the Formosa License Agreement at $1.0 million.

We also capitalized $122,945 of transaction costs in connection with the Formosa License.

In addition, we agreed to pay Formosa up to $4.0 million upon the achievement of certain development milestones and up to $80 million upon the achievement of certain sales milestones.

The trigger for the initial $2.0 million development milestone payment was FDA approval of the Formosa Licensed Product and the effective date of the acceptance by the Company of the transfer and assignment of the FDA approval, which occurred on March 14, 2024.

Based on the achievement of this milestone, we paid Formosa (a) cash in the amount of $1.0 million on April 26, 2024 and (b) 613,496 shares of common stock (calculated pursuant to the Formosa License Agreement at $1.0 million using a five-day volume-weighted average price on March 14, 2024, but valued at $0.4 million on the April 29, 2024 settlement date).

The remaining $2.0 million development milestone (to be fully paid in cash) was earned and accrued upon FDA approval, but payment will be triggered on the earlier of twelve months after FDA approval of the Formosa Licensed Product or six months following the first commercial sale of the Formosa Licensed Product.

On August 7, 2024, we entered into a non-binding collaboration agreement with Formosa under which the companies intend to work to develop EYEN-530, a combination of Formosa’s clobetasol propionate ophthalmic solution with our Optejet dispensing technology, as a potential treatment for acute dry eye flare-ups.

On November 22, 2024, we entered into the First Amendment (the “First Amendment”) to the Supplement to that certain Loan and Security Agreement, dated November 22, 2022 (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P., as administrative agent and collateral agent, Avenue Venture Opportunities Fund, L.P., as a lender and Avenue Venture Opportunities Fund II, L.P., as a lender (together, “Avenue”).

Pursuant to the First Amendment, Avenue agreed to defer principal and interest payments on amounts outstanding under the Loan and Security Agreement until the end of February 2025.

On February 21, 2025, we entered into the Second Amendment (the “Second Amendment”) to the Supplement to the Loan and Security Agreement with Avenue.

Pursuant to the Second Amendment, Avenue agreed to defer principal and interest payments on amounts outstanding until the end of September 2025.

Deferred interest will accrue on the outstanding principal amount at the interest rate (as defined in the Second Amendment).

On December 12, 2024, we announced the engagement of Chardan Capital Markets, LLC (“Chardan”), an investment bank, as the Company’s financial advisor in connection with its evaluation of strategic alternatives.

With assistance from Chardan, the Company will continue to assess a full range of strategic alternatives, including but not limited to, a business combination, sale of the Company, reverse merger, asset sale, or a combination of alternatives, while also carefully managing its expenses.

As part of restructuring to minimize expenses during this process, the Company temporarily halted sales and promotion activities and focused its development efforts on completing the verification and validation studies required for regulatory approval of the Optejet UFD.

This device is designed for users to fill with preserved artificial tears or contact lens rewetting solutions at home, providing greater flexibility while leveraging Optejet’s advanced delivery system.

As of March 2025, Eyenovia is progressing with its development of the Optejet UFD, aiming for a 510K submission in the United States in the fourth quarter of 2025.

On July 26, 2024, we received notice from the staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) providing notification that the Company had regained compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market under Listing Rule 5550(a)(2).

Previously, Nasdaq had notified us on July 2, 2024 that, for the preceding 30 consecutive business days, the closing bid price of our common stock had been below the minimum requirement of $1.00 per share.

The notification letter stated that we would be provided 180 calendar days to regain compliance.

In order to regain compliance, the closing bid price of our common stock had to be at least $1.00 for a minimum of 10 consecutive business days at any time before December 30, 2024.

Subsequently, the Staff determined that, from July 12 to July 25, 2024, the closing bid price of our common stock had been at $1.00 per share or greater.

Accordingly, the Company had regained compliance with Listing Rule 5550(a)(2).

On February 25, 2025, we received notice from the Staff of Nasdaq providing notification that the Company had regained compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market under Listing Rule 5550(a)(2).

Previously, Nasdaq had notified us on September 18, 2024 that, for the preceding 30 consecutive business days, the closing bid price of our common stock had been below the minimum requirement of $1.00 per share.

The notification letter stated that we would be provided 180 calendar days to regain compliance.

In order to regain compliance, the closing bid price of our common stock had to be at least $1.00 for a minimum of 10 consecutive business days at any time before March 17, 2025.

On January 31, 2025, the Company effected a reverse stock split of its common stock at a ratio of 1-for-80 (the “Reverse Split”).

Upon the effectiveness of the Reverse Split, every 80 issued shares of common stock were reclassified and combined into one share of common stock and the corresponding price per share increased by a multiple of 80.

Subsequently, the Staff determined that, from February 3 to February 14, 2025, the closing bid price of our common stock had been at $1.00 per share or greater.

Accordingly, the Company had regained compliance with Listing Rule 5550(a)(2).

Recent Development

On March 18, 2025 we entered into a non-binding letter of intent (the “Letter of Intent”) with Betaliq, a Delaware corporation, relating to a proposed business combination between Eyenovia and Betaliq.

Betaliq is a clinical stage pharmaceutical company with a therapeutic focus on Glaucoma, founded in 2018 through a collaboration with Novaliq GmbH.The parties currently contemplate a reverse merger structure, pursuant to which (i) a newly-formed, wholly-owned subsidiary of Eyenovia would merge with and into Betaliq, with Betaliq as the surviving corporation and a wholly-owned subsidiary of Eyenovia, and (ii) Betaliq would then immediately merge with and into a second newly-formed wholly-owned subsidiary of Eyenovia (the “Second Merger Sub”), with the Second Merger Sub as the surviving corporation.

In connection with the closing of the transaction, Eyenovia expects to change its name to “Betaliq, Inc.” or such other name as determined by Betaliq and change its trading symbol as determined by Betaliq.

As contemplated by the Letter of Intent, Betaliq stockholders would receive (a) shares of Eyenovia common stock (“Eyenovia Common Stock”) and (b) securities convertible into Eyenovia Common Stock in exchange for their shares of Betaliq capital stock (“Betaliq Capital Stock”) based on the Exchange Ratio (defined below).

Outstanding equity awards, convertible notes, warrants, and any other equity interests or instruments convertible into Betaliq Capital Stock (“Betaliq Stock Rights”) would be assumed by Eyenovia and become the equity awards, convertible notes, warrants, and any other equity interests or instruments convertible into equity interests of Eyenovia, as applicable, based on the Exchange Ratio in a manner mutually agreeable to Betaliq and Eyenovia.

As contemplated by the Letter of Intent, the conversion of the Betaliq Capital Stock and Betaliq Stock Rights would be effected pursuant to an exchange ratio (the “Exchange Ratio”) intended to result in the following approximate aggregate post-closing percentage ownership:

(i) the equity holders of Betaliq immediately prior to the closing (including all Betaliq Stock Rights) would own approximately 83.7% of the equity of the combined company on a fully diluted basis, and (ii) the equity holders of Eyenovia immediately prior to the closing (including outstanding equity awards, convertible notes, warrants, and any other securities or instruments convertible into or exercisable for equity interests of Eyenovia) would own approximately 16.3% of the equity of the combined company on a fully diluted basis.

These ownership percentages assume a valuation of approximately $77 million for Betaliq and approximately $15 million for Eyenovia, Eyenovia “net cash” (which will include, among other things, unrestricted current assets in the form of cash and cash equivalents as of the closing minus current liabilities and all expenses related to the proposed transaction as of the closing) of zero at closing, and the inclusion of Optejet and related Eyenovia assets, and are subject to adjustment as described in the Letter of Intent.

Following the closing of the business combination, the combined company’s board of directors will be comprised of members to be mutually agreed upon by the parties.

Assuming signing and closing of the definitive agreement occurs, stockholder approval of the issuance of Eyenovia securities in excess of limits imposed by Nasdaq listing rules to the former Betaliq stockholders will be sought at a meeting to take place following the closing.

The parties intend to negotiate a definitive business combination agreement consistent with the provisions of the Letter of Intent as well as other terms and conditions typical for transactions of this nature.

During the binding exclusivity period set forth in the Letter of Intent, which ends on May 16, 2025 but is subject to extension, the parties have agreed not to solicit or encourage submission of, or participate in discussions or enter into any agreement regarding any other acquisition proposal.

We are currently exploring strategic business options intended to maximize shareholder value including, if possible, continued commercialization of Mydcombi and clobetasol propionate and completing the development of our Optejet device.

Our goal is to become a leading developer and licensor of the Optejet in multiple formats;

beginning with the UFD, then adding device-drug combinations and a digital health platform for improved patient care outcomes.

These unique products would be commercialized internally and/or with licensees and development partners globally.

The key elements of our strategy to achieve this goal are:

Establish a portfolio of first-in-class piezo-print micro-therapeutic products for multiple eye treatments through the 505(b)(2) pathway with the FDA.

Obtain clearance from the U.S.

FDA on the Optejet® UFD through the 510K pathway.

We are focused on submitting the Optejet for use with artificial tears and contact lens rewetting solutions as a device to the FDA.

Successful clearance from the FDA would then establish the existing device for later drug-device submissions through the 505(b)(2) registration pathway, which may reduce development risk compared to new molecular entity programs by working with known compounds with well-established safety and efficacy profiles.

Through partnerships and licensings agreements, establish a portfolio of first-in-class piezo-print micro-therapeutic products for multiple eye treatments through the 505(b)(2) pathway with the FDA.

We are focused on integrating our next-generation technology with therapeutic compounds already well established in the topical treatment of ophthalmic indications.

We believe that the 505(b)(2) registration pathway, which reduces development risk compared to new molecular entity programs by working with known compounds with well-established safety and efficacy profiles, will be available for our development pipeline.

We believe our pipeline of patented micro-therapeutic product candidates is highly differentiated by our improved tolerability and enhanced compliance profile and that our late-stage development programs could lead to additional NDA submissions in novel indications where the products can have unique dosing and therapeutic profiles.

We believe that the 505(b)(2) registration pathway, which may reduce development risk compared to new molecular entity programs by working with

known compounds with well-established safety and efficacy profiles, will be available for our development pipeline.

We believe a pipeline of patented micro-therapeutic product candidates would be highly differentiated by our improved tolerability and enhanced compliance profile and that our late-stage development programs could lead to additional NDA submissions in novel indications where the products can have unique dosing and therapeutic profiles.

We believe that this could lead to favorable pricing and a reduced risk of generic competition.

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Leverage our Optecare ™ technology to introduce and develop patient-specific compliance and treatment adherence enhancement programs.

The Optejet’s mobile e-health technology is designed to track when a patient administers treatments, allowing physicians to monitor patient compliance more accurately.

The Optejet’s mobile e-health technology, Optecare, is designed to track when a patient administers treatments, allowing physicians to monitor patient compliance more accurately.

We believe this could enhance patient compliance and improve compliance monitoring by empowering patients and physicians with access to dynamic, real-time monitoring and compliance data for a more intelligent, informed and personalized therapeutic paradigm.

Develop next-generation targeted microdose treatments for other ophthalmic diseases independently or in collaboration with third parties.

Develop next-generation targeted microdose treatments for other ophthalmic diseases in collaboration with third parties.

The Optejet also may be suitable for new molecular entities and applications.

Leveraging our existing platform technology, we plan to continue developing, either independently or through strategic relationships with third parties, other product candidates for various eye diseases that can be administered using the Optejet and additional applications for the Optejet.

Develop therapeutic solutions for ophthalmic conditions with high unmet needs and no approved therapy.

We plan to target chronic ophthalmic conditions with a high unmet medical need.

By leveraging our piezo-print microdosing technology, we aim to reach conditions where there are no approved drug therapies.

For example, our MicroPine program involves a proprietary formulation of low-dose atropine intended to slow myopia progression in the pediatric population.

There are currently no commercially-available medical therapies in the United States to treat this indication.

Limitations of Conventional Eye Therapies

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Severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate.

Mydcombi contains tropicamide and phenylephrine.

However, as demonstrated in our two Phase III studies for this product candidate, patients administering Mydcombi reported few ocular adverse events and no systemic adverse events when they administered our microdosed product candidate.

Compared with historical data for traditional eye drops, Mydcombi appeared to be much better tolerated, with low systemic absorption of phenylephrine alone.

With the Optejet platform technology, we believe that the known adverse event profile of pilocarpine, including headaches, also may be moderated to make MicroLine the preferred choice for presbyopia over other potential pilocarpine drop options.

The same is true with MicroPine, where we believe that microdosing may result in a better tolerated product for children using topical ophthalmic atropine.

Our Solution:

Optejet Base and Cartridge

The Optejet dispenser delivers doses of approximately 7-9 µL, directly coating the corneal surface where 80% of intraocular drug penetration occurs.

We believe that microdosing may reduce drug and toxic preservative exposure by more than 75%, thus reducing ocular irritation, and resulting in potentially gentler treatments without compromising the desired clinical effect.

We believe that we are one of the only companies with clinical stage technology for targeted microdosing of ophthalmic investigational therapies having fully completed the Phase III clinical studies needed and made an NDA submission.

The Optejet is based on MAP, which is also used for pixel-sharp high-precision inkjet printing.

We believe that we are the only company with an FDA-approved product that uses a targeted, metered microdosed spray of ophthalmic topical therapy.

The Optejet is based on microdose array print, or MAP, technology, which is also used for pixel-sharp high-precision inkjet printing.

The technology is optimized for and applied in ophthalmic delivery to achieve microdosing that can be many times more precise than conventional eye droppers.

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Thus, physicians can make decisions regarding therapeutic regimens with knowledge of patient compliance.

The FDA has determined that our Optejet products are treated as combination drug/device products, with CDER as the lead reviewing center.

As such, we do not anticipate needing separate FDA approval for the Optejet dispenser alone.

Microdose administration of topical ophthalmic drugs with the Optejet has been tested in preclinical models and clinical trials and shown to provide many advantages over administrations of eye drops.

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Shown below is mean pupil diameter change from baseline for the 24 eyes studied.

The asterisk at t=75 min indicates EYN is statistically better than PE 2.5% (p=0.009).

The asterisk at t=75 min indicates EYN was observed to be statistically better than PE 2.5% (p=0.009).

PUPIL DIAMETER, INCREASE FROM BASELINE, MM

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In 2018, Eyenovia completed a third early phase trial (EYN-POC-PG-21) to extend the findings of the two previous trials evaluating Optejet administration of mydriatic agents.

This study was a single-center, open-label, prospective, crossover design evaluating the usability, patient tolerability, and proof-of-concept of microdose administration of commercial latanoprost 0.005% using

Thirty healthy volunteer subjects (60 eyes) were evaluated for eligibility and consented to study participation.

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Based on the results of these studies further validating microdose delivery of ophthalmic medication, we initiated Phase III programs in mydriasis in late 2018, progressive myopia in 2019, and presbyopia in 2020.

Our Product and Product Candidates

Eyenovia currently has two FDA-approved products, Mydcombi and clobetasol propionate, and two research programs:

MicroLine (for presbyopia) and MicroPine (for progressive myopia).

On May 5, 2023, we received notification from the FDA of the approval of Mydcombi (tropicamide and phenylephrine metered ophthalmic spray) for diagnostic pupil dilation.

The approved label for the product was advantageous compared with eye drop formulations, with adverse events being infrequent and mild and the incidence of stinging at less than 1% in clinical studies.

Our Products and Product Candidate

Eyenovia currently owns or licenses two FDA-approved products, Mydcombi and clobetasol propionate.

Mydcombi is the only FDA-approved fixed combination of the two leading pupil dilation drugs, tropicamide and phenylephrine, delivered with our Optejet technology.

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The benefits of Mydcombi include effective, reliable dilation with low risk of cross-contamination as compared with eye dropper bottles, ease of use for technicians and doctors, and good tolerability for patients.

We believe the market for Mydcombi exceeds $250 million in the United States alone.

Background of Mydriasis and Market Opportunity

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Mydcombi (TR-PH) was statistically and clinically superior to its components (TR – tropicamide, PH – phenylephrine) as well as placebo at all timepoints post-dosing.

By twenty minutes post-dosing, the mean pupil dilation was above 6mm, more than sufficient for a thorough clinical examination.

By 20 minutes post-dosing, the mean pupil dilation was above 6mm, more than sufficient for a thorough clinical examination.

All adverse events were transient and mild and occurred in fewer than 2% of patients.

Commercial Plans

We plan to hire a ten-person sales team, managed by two experienced sales directors, to promote Mydcombi directly to institutions and key ophthalmic and optometric offices.

We have obtained wholesale licenses nation-wide and will be handling distribution internally to maintain control over the product and help ensure a good experience for this novel technology.

Ordering and reordering will be managed on-line at EyenoviaRx.com.

Clobetasol Propionate

We have licensed this topical ocular steroid from Formosa Pharmaceuticals and will have commercial rights to this product within the United States.

We have licensed this topical ocular steroid from Formosa and will have commercial rights to this product within the United States.

The product was approved by the FDA on March 4, 2024.

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Adverse events were few and mild, including 1% of patients experiencing elevated intraocular pressure, which may have been related to the surgery itself.

We plan to leverage our Mydcombi sales team to also cover promotion of this new, differentiated eye drop, with an anticipated launch in the second half of 2024.

MicroLine is our proprietary microdosed version of pilocarpine, a well-understood ophthalmic medication that can dose-dependently induce miosis, or a contraction of the pupil.

MicroLine is our investigational proprietary microdosed version of pilocarpine, a well-understood ophthalmic medication that can dose-dependently induce miosis, or a contraction of the pupil.

It is a direct acting cholinergic parasympathomimetic agent that stimulates muscarinic acetylcholine receptors present on smooth muscles, including those in the iris and ciliary body.

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There are psychological factors accompanying the use of spectacles and bifocals for the first time, as well as situational inconvenience for either not being able to see well or having to use a vision aiding device.

With MicroLine, we plan to introduce a pharmaceutical option for improving near vision that can work as a companion to spectacles, for when patients wish not to use their reading glasses.

We believe MicroLine may have the potential to be a pharmaceutical option for improving near vision that can work as a companion to spectacles, for when patients wish not to use their reading glasses.

Our market research indicates the highest interest in the product concept among people aged 40 to 55 years who otherwise have normal vision and household income in the top half of the country, representing a potential market of approximately 18 million people.

Phase III Clinical Development Programs

We are evaluating whether topical ocular microdosing of pilocarpine using the Optejet dispenser in presbyopic individuals can effectively improve near vision without compromising distance vision and without causing the undesirable side effects of traditionally administered pilocarpine.

Our initial Phase III Study, VISION-1, showed that pilocarpine 2% provided a statistically superior improvement in functional near vision and an acceptable safety profile in presbyopic subjects with baseline distance-corrected near visual acuity better than 20/80.

We have completed two Phase III studies using our Optejet device.

Our initial Phase III study, VISION-1, showed that pilocarpine 2% provided a statistically superior improvement in functional near vision and an acceptable safety profile in presbyopic

subjects with baseline distance-corrected near visual acuity better than 20/80.

Our second Phase III study, VISION-2 evaluated the safety, tolerability, and efficacy of Optejet-administered microdosing of pilocarpine 2% as an ophthalmic spray versus placebo.

A key therapeutic program for Eyenovia is our first-in-class topical treatment for pediatric progressive myopia, a disease reaching epidemic proportions according to the American Academy of Ophthlmology.

Background of Progressive Myopia and Market Opportunity

Myopia is an ocular disorder that results in blurry vision when looking at distant objects.

This happens when the eyeball is too long or corneal curvature is too steep causing light entering the eye to be incorrectly focused.

Myopia is one of the most common refractive errors seen in children.

Myopia that is present in young children tends to increase through the school years.

As myopia progresses, so does the risk of retinal detachment, cataracts, myopia maculopathy and even blindness.

It is estimated that over 25 million children in the United States suffer from progressive myopia, with approximately 5 million children being at high risk.

Progressive Myopia with Retinal Atrophy Changes

While currently there are no FDA-approved therapies for myopia progression, there is growing evidence of the therapeutic benefit of topical atropine ophthalmic solution, an anticholinergic agent used for pupil dilation and treatment of lazy eye, as a treatment to slow progression.

Academic groups have demonstrated that low dose atropine solution reduces myopia progression 60-70%, with sustained effect through three years.

A recent therapeutic evidence assessment and review by the American Academy of Ophthalmology, indicates Level 1 (highest) evidence of efficacy for low dose atropine for reduction of progressive myopia (Ophthalmology 2017;124:1857-1866;

Ophthalmology 2016;

123(2) 391:399).

While atropine 1% ophthalmic solution is FDA-approved and commercially available in the United States for pupil dilation and treatment of lazy eye, commonly reported side effects such as burning and stinging during drop administration, and blurred vision and light sensitivity associated with its use make it undesirable for the

treatment of progressive myopia in the pediatric population, thus impeding the drug’s clinical utility and adoption for myopia progression.

Our MicroPine program involves the development of a micro-formulation (dilute and low volume) of atropine ophthalmic solution for reduction of myopia progression in children.

Delivered with the Optejet dispenser, the product is also intended to make use of the Optejet’s Optecare system to assist with compliance and adherence.

The potential market opportunity for MicroPine in the United States alone may be $1.2 billion, according to third party analysts.

Phase III Clinical Development Program

The FDA accepted Eyenovia’s IND to initiate our single Phase III registration trial of MicroPine (the CHAPERONE study) to reduce the progression of myopia in children.

Eyenovia enrolled its first patient in the CHAPERONE study in June 2019.

The trial is a U.S.-based, multi-center, randomized, double-masked study enrolling more than 400 children and adolescents.

Participants will be equally randomized to receive nightly treatment with either of two MicroPine treatment concentrations or a placebo control arm.

The primary assessment of efficacy is based on reduction in myopia progression after 3 years of medication use.

We expect that over half of the intended enrollment of CHAPERONE will have reached the three-year efficacy endpoint in late 2024.

At that time, we plan to discuss an interim analysis with the FDA to determine if there is a more efficient pathway towards approval for the product.

Since completing these studies, the market opportunity has markedly deteriorated, and we have chosen to put this program on hold and reallocate our resources towards larger opportunities.

When and if the market improves, we have kept open the option to continue development of MicroLine, which would include a meeting with the FDA to review our clinical data to date.

Our Technology

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Doses are delivered by attaching the cartridge to the base, pressing an activation button which loads a single drug dose, then, holding it between one and two inches from the eye while looking directly into an illuminated circle, pressing a second button to emit the micro-droplet delivered medication.

The micro-droplets are emitted in a

quickly repeating array, that in aggregate form a directed mist.

The micro-droplets are emitted in a quickly repeating array, that in aggregate form a directed mist.

Solution is dispensed to the ocular surface in less than 100 milliseconds between the time the first droplet hits the corneal surface to the completion of dose delivery, which is faster than the average involuntary blink response time.

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Our patented system takes aspects of piezo-driven printer technology, and applies it to the delivery of therapeutics to the eye.

Sales and Marketing

We are building a sales and distribution organization that will be staged to match with our planned product launches and size of the opportunities.

We have hired and plan to deploy ten sales representatives and two national sales directors who will focus on the promotion of Mydcombi as well as clobetasol propionate.

We have also built the infrastructure to act as a wholesaler for Mydcombi, and will be partnering with an online pharmacy for the launch of clobetasol propionate.

Our management team and directors, which are leading the commercialization planning of our lead product candidates in the United States, have substantial experience in the commercialization of ophthalmic therapeutics.

Mydcombi is a cash-pay pharmaceutical supply, administered and purchased by clinics and doctors for in-office use.

The cost of the product is folded into the established reimbursement for the comprehensive eye exam and thus lends itself to a single specialty-pharmacy distribution model without the need for formulary negotiations and contracting at the managed care level.

As such, we estimate Mydcombi sales and marketing costs will be significantly below that of a conventional prescription-based pharmaceutical product.

As a highly differentiated product with meaningful benefits for both providers and patients, we anticipate fast adoption, especially because part of our strategy is to maintain good economics for the practice.

Lastly, we believe that we can be successful with a limited in-person sales force as we are not aware of any active competition in this space.

Clobetasol propionate is our second product for commercialization.

Like Mydcombi, clobetasol will also be “cash-pay,” negating the need for infrastructure focused on managed care reimbursement.

Clobetasol will be sold in two ways:

(1) prescribed by ocular surgeons to patients through an online pharmacy, and (2) purchased directly from Eyenovia by offices who sell the medication directly to their patients as part of their overall fee.

MicroLine, if approved, would again be “cash-pay”.

If we decide to pursue approval, and receive approval, for this product, we would expand our sales force in the United States and focus on promotion in the optometrist office.

We also plan to leverage the experience that these offices have had with Mydcombi to speed acceptance and prescribing of MicroLine to appropriate patients.

MicroPine is our fourth expected product for commercialization.

MicroPine is planned to be launched as a reimbursed product, similar to glaucoma medications, where formulatory position is obtained through negotiations with payers.

We would make use of our planned sales force calling on optometrists, many who have a specialty in treating pediatric progressive myopia.

Manufacturing

For clinical supply, Eyenovia relies on internal manufacturing capabilities along with third-party contract manufacturing organizations (CMOs) to produce the Optejet® cartridges and bases.

In order to streamline our manufacturing process and reduce costs, Eyenovia has invested in two of its own facilities, one in Redwood City, CA that was recently FDA-approved for Mydcombi cartridge production, and one in Reno, NV that has recently been FDA-approved for ejector and base unit manufacturing.

In order to streamline our manufacturing process and reduce costs, Eyenovia has invested in two of its own facilities, one in Redwood City, CA that is FDA-approved for Mydcombi cartridge production, and one in Reno, NV that is FDA-approved for ejector and base unit manufacturing.

We also use a CMO, Coastline International in Mexico, for production of certain subassemblies as well as a CMO for the production of our drug substances.

We are currently developing and manufacturing the second generation of our device, and we expect our strategy for moving from the first to the second generation device to be the subject of an FDA meeting this summer.

Assuming we come to an agreement with the FDA to demonstrate comparability between the two devices, this should provide a path for Eyenovia to introduce the second generation platform to the commercial market in 2026.

We are currently developing and manufacturing the second generation of our device, and on July 24, 2024, we received written comments from the FDA broadly outlining the design of a clinical bridging study to transition Mydcombi into our new Gen-2 Optejet device.

Assuming we come to an agreement with the FDA to demonstrate comparability between the two devices, this should provide a two-year path for Eyenovia to introduce the second generation platform.

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.

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Many of our competitors have significantly greater financial and human resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.

Smaller and other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Smaller and other early stage companies may also prove to be significant competitors, particularly

through collaborative arrangements with large and established companies.

These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient enrollment for clinical trials, as well as in acquiring products, product candidates or other technologies that we may target to in-license or acquire in pursuit of our updated business plan.

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Additionally, we believe our “value pricing” approach, where patients can expect to pay a fixed amount regardless of their insurance coverage or status, will further differentiate us in this market.

For MicroLine, Allergan has launched Vuity, a pilocarpine eye drop for the treatment of presbyopia.

Along with Allergan, there are other pharmaceutical companies developing therapies for presbyopia, none of which makes use of microdosing technology or deliver medication as a spray.

For MicroPine, we are not aware of any FDA-approved drugs to slow the progression of myopia.

There are other versions of traditional eye drop atropine under development by other pharmaceutical companies for this indication.

There also are versions of compounded topical atropine that have not been tested for their safety or efficacy that are dispensed on an individual basis to patients.

Intellectual Property

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and foreign patent applications for our future innovations.

We are currently engaged in an appeal taken from three inter partes review (“IPR”) proceedings successfully challenging the validity of certain patents owned by Sydnexis, Inc.

The Patent Trial and Appeal Board instituted IPR2022-00384, filed by Eyenovia on December 29, 2021 and challenging claims in U.S.

and IPR2022-00414 and IPR2022-00415, both filed by Eyenovia on January 7, 2022, and challenging claims in U.S.

10,940,145 and 10,888,557, respectively.

All three IPR proceedings were instituted and then consolidated for trial.

On July 13, 2023, the Board determined in a final written decision that all claims across the three challenged Sydnexis patents were unpatentable.

Sydnexis subsequently appealed to the U.S.

Court of Appeals for the Federal Circuit, and briefing is currently in progress, with a decision anticipated in 2025.

As of December 31, 2023, we owned seventeen U.S.

issued and allowed utility patents or design patents, and ten pending U.S.

patent applications, as well as 97 issued foreign patents, and 26 pending foreign patent applications, and one pending international PCT application.

As of December 31, 2024, we owned twenty-two U.S.

issued and allowed utility patents or design patents, and nine pending U.S.

patent applications, as well as 101 issued foreign patents, and 23 pending foreign patent applications.

Patent coverage within the portfolio includes issued and pending patent applications related to the following devices and methods:

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patent will be obtained and, if obtained, the duration of such extension.

Similar patent term

extension/reduction provisions are available in the European Union and other jurisdictions.

Similar patent term extension/reduction provisions are available in the European Union and other jurisdictions.

In the future, if and when our product candidates receive approval by the FDA or foreign regulatory authorities, we will apply for patent term extensions on issued patents covering our products to the extent available under the applicable law, depending upon the length of any such clinical trials for any product and other factors.

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The following words are trademarks in our Company’s trademark portfolio and are the subject of either registration, or application for registration, in the United States:

APERSURE TM , EYENOVIA®, OPTEJET®, EYELATOVA TM , EYETANO TM , MYDCOMBI TM .

APERSURE TM , EYENOVIA®, OPTEJET®, EYELATOVA TM , EYETANO TM and MYDCOMBI TM .

In addition to the trademarks noted above, we will file trademark applications for new trademarks registrations to protect our market positions in the United States and other jurisdictions on an ongoing basis.

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Government authorities in the United States, at federal, state and local levels, and in other countries and jurisdictions, including the European Union, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of pharmaceutical products.

The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.

The processes for obtaining regulatory approvals in the United States and

in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.

Government Regulation

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117-328) amended the FDCA and the Public Health Service Act to specify that nonclinical testing for drugs and biologics may, but is not required to, include in vivo animal testing.

According to the amended language, a sponsor may fulfill nonclinical testing requirements by completing various in vitro assays (e.g., cell-based assays, organ chips, or microphysiological systems), in silico studies (i.e., computer modeling), other human or nonhuman biology-based tests (e.g., bioprinting), or in vivo animal tests.

According to the amended language, a sponsor may fulfill nonclinical testing requirements by completing various in vitro assays (e.g., cell-based assays, organ chips, or

microphysiological systems), in silico studies (i.e., computer modeling), other human or nonhuman biology-based tests (e.g., bioprinting), or in vivo animal tests.

The results of the nonclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among other things, are submitted to the FDA as part of an IND.

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Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved NDA.

of a request for an IND, applicants must submit a protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND.

In support of a request for an IND, applicants must submit a protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND.

In addition, the results of the nonclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among other things, are submitted to the FDA as part of an IND.

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Disclosure of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial.

Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and may prevent the non-compliant party from receiving future grant funds from the federal government.

Failure to timely register a covered clinical study or to submit study results as provided for in the law can give

rise to civil monetary penalties and may prevent the non-compliant party from receiving future grant funds from the federal government.

The NIH’s Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and the government has brought enforcement actions against non-compliant clinical trial sponsors.

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Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include, among other things, the requirement that all research subjects provide their informed consent in writing before their participation in any clinical trial.

Clinical trials are conducted in accordance with

written study protocols detailing, among other things, study objectives, participant inclusion and exclusion criteria, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

Clinical trials are conducted in accordance with written study protocols detailing, among other things, study objectives, participant inclusion and exclusion criteria, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

A protocol for each phase of a clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND.

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The FDA is, however, authorized to approve an alternative type of NDA under Section 505(b)(2) of the FDCA.

This type of application allows the applicant to rely, in part, on the FDA’s previous findings of safety and efficacy for a drug product previously

approved under an NDA, published literature, or a combination of both.

This type of application allows the applicant to rely, in part, on the FDA’s previous findings of safety and efficacy for a drug product previously approved under an NDA, published literature, or a combination of both.

Specifically, Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

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The FDA may refer an application for a novel drug product to an advisory committee.

Typically, an advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions.

Typically, an advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation

as to whether the application should be approved and under what conditions.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

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The accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit.

As a result, a drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase IV or post-approval clinical trials to

confirm the effect on the clinical endpoint.

As a result, a drug candidate approved on this basis

is subject to rigorous post-marketing compliance requirements, including the completion of Phase IV or post-approval clinical trials to confirm the effect on the clinical endpoint.

Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, would allow the FDA to withdraw the drug from the market on an expedited basis.

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There also are continuing, annual program fee requirements for any marketed products, as well as new application fees for supplemental applications with clinical data.

In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies, and are subject to periodic announced or unannounced inspections by

the FDA and these state agencies for compliance with cGMP requirements.

Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented.

FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use.

FDA regulations also require investigation and correction of any

deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use.

Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance.

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In 1984, with passage of the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, that established an abbreviated regulatory scheme authorizing the FDA to approve generic drugs based on an innovator or “reference” product, Congress also enacted Section 505(b)(2) of the FDCA, which provides a hybrid pathway combining features of a traditional NDA and a generic drug application.

To obtain approval of a generic drug, an applicant must submit an abbreviated new drug

application, or ANDA, to the agency.

To obtain approval of a generic drug, an applicant must submit an abbreviated new drug application, or ANDA, to the agency.

In support of such applications, a generic manufacturer may rely on the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference-listed drug, or RLD.

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If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months, including orphan drug exclusivity.

This is not a patent term extension,

but it effectively extends the regulatory period during which the FDA cannot approve another application.

This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application.

The FDA’s issuance of a Written Request does not require the sponsor to undertake the described studies.

Patent Term Restoration and Extension

A patent claiming a new drug product may be eligible for a limited patent term extension under the Hatch-Waxman Amendments, which permits a patent restoration of up to five years for patent term lost during product development and the FDA regulatory review.

regulatory review.

The restoration period granted is typically one-half the time between the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the ultimate approval date.

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Although the FDA is not bound by the advisory panel decision, it considers such recommendations when making final decisions on approval.

In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with the QSR.

In addition, the FDA will conduct

a preapproval inspection of the manufacturing facility to ensure compliance with the QSR.

New PMA applications or PMA application supplements are also required for product modifications that affect the safety and efficacy of the device.

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● post-market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Under the FDA medical device reporting, or MDR, regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or a similar device of such manufacturer were to

The decision to file an MDR involves a judgment by the manufacturer.

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Additionally, the FDA has the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture.

The authority to require a recall must be based on an FDA finding that there is reasonable probability that the device would cause serious adverse health consequences or death.

The authority to require a recall must be based on an FDA finding that there is reasonable probability

that the device would cause serious adverse health consequences or death.

Manufacturers may, under their own initiative, recall a product if any distributed devices fail to meet established specifications, are otherwise misbranded or adulterated, or if any other material deficiency is found.

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The FDA’s Office of Combination Products, or OCP, was established to provide prompt determination of the FDA Center with primary jurisdiction over the review and regulation of a combination product;

ensure timely and effective premarket review by overseeing the timeliness of and coordinating reviews involving more than one center;

ensure timely and effective premarket review by

overseeing the timeliness of and coordinating reviews involving more than one center;

ensure consistent and appropriate post-market regulation;

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NMPA’s Drug Evaluation Center (CDE) is responsible for the review of drug clinical trial applications and drug marketing authorization applications for overseas manufactured drugs.

After completing the pre-clinical studies and clinical trials supporting the drug registration, the applicant submits the drug marketing authorization application according to the applicable requirements.

After completing the pre-clinical studies and clinical trials supporting the drug registration, the applicant submits the drug marketing authorization application according to the applicable

requirements.

After the formal examination of the application materials, acceptance will be given if they meet the requirements.

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In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable regulatory approvals.

Obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained.

coverage and adequate reimbursement will be obtained.

Nonetheless, product candidates might not be considered medically necessary or cost effective.

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The United States and some foreign jurisdictions are considering enacting or have enacted a number of additional legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our product candidates profitably, if approved.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

In addition, the containment of healthcare costs has become a priority of federal and state governments and the prices of therapeutics have been a focus in this effort.

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Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease utilization of and reimbursement for any approved products we may market in the future.

While Medicare regulations apply only to drug benefits for Medicare beneficiaries, private payors

often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates.

While Medicare regulations apply only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates.

Therefore, any reduction in reimbursement that results from federal legislation or regulation may result in a similar reduction in payments from private payors.

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There has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries, presidential executive orders and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for pharmaceutical products.

Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products and services, implementing reductions in Medicare and other healthcare funding and

applying new payment methodologies.

In addition to the sweeping reforms contained in the ACA, other legislative changes have been proposed and adopted in the United States that may affect healthcare expenditures.

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As of March 15, 2025, we had 14 total employees.

All 57 are full-time employees and there are no part-time employees.

Thirteen are full-time employees and one is part-time.

We also engage various consultants and contractors.

We consider our relations with our employees to be good.

To successfully commercialize our product candidates, we must be able to attract and retain highly skilled personnel.

We anticipate hiring additional employees during 2024.

To successfully develop our product candidates, we must be able to attract and retain highly skilled personnel.

We continually evaluate the business need and opportunity and balance in-house expertise and capacity with outsourced expertise and capacity.

Currently, we outsource substantial clinical trial work to clinical research organizations and manufacturing to contract manufacturers.

We believe that our future success largely depends upon our continued ability to attract and retain highly skilled employees.

Biotechnology and pharmaceutical companies both large and small compete for a limited number qualified applicants to fill specialized positions.

Biotechnology and pharmaceutical companies both large and small compete for a limited number of qualified applicants to fill specialized positions.

To attract qualified applicants, we offer a total rewards package potentially consisting of base salary and cash target bonus, a comprehensive benefit package and equity compensation.

5 unchanged sentences

Information About Our Directors and Executive Officers

Tsontcho Ianchulev, M.D., M.P.H.

Charles Mather IV

Chairman and Director of Eyenovia

Tsontcho Ianchulev, M.D., M.P.H.

Director of Eyenovia

Michael Geltzeiler

1 unchanged sentence

Rachel Jacobson

Director of Eyenovia and President of the Drone Racing League (DRL)

Charles Mather

Director of Eyenovia

3 unchanged sentences

Director of Eyenovia

Chief Executive Officer and Director of Eyenovia

John Gandolfo

Chief Financial Officer and Secretary of Eyenovia

Chief Operating Officer of Eyenovia

Chief Executive Officer, Principal Financial Officer and Director of Eyenovia

Chief Operating Officer

Available Information

2 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