What changed in this filing

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Item 1. Business

2026-03-02 compared with 2025-03-27 · 587 added, 768 removed, 139 unchanged (91% of the section changed)

We are a leading eyecare pharmaceutical

company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S.

eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription

pharmaceutical products accessible and affordable to millions of Americans each year.

We own commercial rights to one of the largest

portfolios of branded ophthalmic pharmaceutical products in North America, all of which are marketed under the Harrow name.

and operate ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical-compounding businesses.

Branded Ophthalmic Pharmaceuticals

the past few years, we have invested in broadening our product portfolio of Food and Drug Administration (“FDA”)-approved

Our investments in this regard have led to the pursuit and completion of several announced transactions, all of which are focused

on eyecare pharmaceuticals primarily for the U.S.

and Canadian markets.

We believe that our continued investments in these and other

products will result in our ability to provide more physician prescribers and their patients with access to a complete portfolio of affordable

eyecare pharmaceuticals to address their clinical needs.

commercial rights to the following products that we market and sell:

(chloroprocaine hydrochloride ophthalmic gel) 3% a low-viscosity gel indicated for

ocular surface anesthesia.

(cyclosporine ophthalmic solution) 0.1%, utilizes a novel water-free vehicle (perfluorobutylpentane)

based on semifluorinated alkanes, indicated for the treatment of the signs and symptoms associated

with dry eye disease.

· TRIESENCE ®

(triamcinolone acetonide injectable suspension) 40 mg/ml, a steroid injection for the

treatment of certain ophthalmic diseases and for visualization during vitrectomy.

(moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic

eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms.

(nepafenac ophthalmic suspension) 0.3%, a non-steroidal, anti-inflammatory eye drop

indicated for pain and inflammation associated with cataract surgery.

(fluorometholone acetate ophthalmic suspension) 0.1%, a corticosteroid prepared as

a sterile topical ophthalmic suspension indicated for use in the treatment of steroid-responsive

inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment

(natamycin ophthalmic suspension) 5%, a sterile, antifungal drug for the treatment

of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including

Fusarium solani keratitis.

ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, a topical antibiotic

and corticosteroid combination for steroid-responsive inflammatory ocular conditions for

which a corticosteroid is indicated and where superficial bacterial ocular infection or a

risk of bacterial ocular infection exists.

(cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated

for treatment of ocular itching associated with allergic conjunctivitis.

(cyclosporine ophthalmic emulsion) 0.1%, an orphan designated drug that is a calcineurin

inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis.

(nepafenac ophthalmic suspension) 0.1%, a non-steroidal, anti-inflammatory eye drop

indicated for pain and inflammation associated with cataract surgery.

· FRESHKOTE ®

Preservative Free (PF) is a lubricant eye drop that does not require a prescription

and temporarily relieves burning, itching and other dry eye symptoms.

(neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is an eye

drop used to treat steroid-responsive inflammatory ocular conditions where bacterial infection

or a risk of bacterial ocular infection exist.

(dexamethasone ophthalmic suspension) 0.1%, a steroid eye drop for steroid-responsive

inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment

of the globe.

1% (apraclonidine hydrochloride) 0.5%, an ophthalmic solution in a sterile isotonic

solution indicated to control or prevent post-surgical elevations in intraocular pressure

that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG

posterior capsulotomy.

0.5% (apraclonidine hydrochloride) an ophthalmic solution indicated for short-term

adjunctive therapy in patients on maximally tolerated medical therapy who require additional

intraocular pressure (or IOP) reduction.

are a leading provider of ophthalmic disease management solutions in North America, and were founded with a commitment to deliver safe,

effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes.

For over a decade, we

have partnered with U.S.

eyecare professionals to develop a comprehensive portfolio of high-quality products used to manage ophthalmic

conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration,

cataracts, refractive errors, glaucoma, and a range of other ocular surface conditions and retina diseases.

By prioritizing clinical

value – to the provider and the patient – Harrow empowers professionals to enhance patient outcomes and preserve vision.

By combining our culture of creativity, entrepreneurship and groundbreaking innovation with operational discipline and strong financial

performance, we are building a future where life-changing ophthalmic treatments are within reach for all.

Ophthalmic Pharmaceuticals

the past several years, we have expanded our portfolio of the U.S.

Food and Drug Administration (the “FDA”)-approved ophthalmic

products through acquisitions, licensing transactions, and internal investment.

These efforts are focused primarily on the U.S.

We believe continued investment in our branded portfolio supports our ability to offer eyecare prescribers and patients access

to a broader range of ophthalmic therapies across multiple disease states.

commercial rights to the following products, which

we market and sell:

(chloroprocaine hydrochloride ophthalmic gel) 3%, a low-viscosity gel indicated for ocular surface anesthesia.

(cyclosporine ophthalmic solution) 0.1%, utilizes a novel water-free vehicle (perfluorobutylpentane) based on semifluorinated

alkanes, indicated for the treatment of the signs and symptoms associated with dry eye disease.

(triamcinolone acetonide injectable suspension) 40 mg/ml, a steroid injection for the treatment of certain ophthalmic diseases

and for visualization during vitrectomy.

(ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated

for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD),

Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization

We expect to commercially launch BYOOVIZ in mid-2026.

(aflibercept-yszy) 0.05mL injection, an FDA-approved EYLEA biosimilar indicated for the treatment

of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and

Diabetic Retinopathy (DR).

We expect to commercially launch OPUVIZ in mid-2027.

(clobetasol propionate ophthalmic suspension) 0.05% a high-potency ophthalmic corticosteroid

formulated using proprietary APNT® nanoparticle formulation technology, indicated for

the treatment of post-operative inflammation and pain following ocular surgery.

to commercially launch BYQLOVI in mid-2026.

(moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial

conjunctivitis caused by susceptible strains of organisms.

(nepafenac ophthalmic suspension) 0.3%, a non-steroidal, anti-inflammatory eye drop indicated for pain and inflammation associated

with cataract surgery.

(fluorometholone acetate ophthalmic suspension) 0.1%, a corticosteroid prepared as a sterile topical ophthalmic suspension

indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea,

and anterior segment of the eye.

(natamycin ophthalmic suspension) 5%, a sterile, antifungal drug for the treatment of fungal blepharitis, conjunctivitis, and

keratitis caused by susceptible organisms, including Fusarium solani keratitis.

ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, a topical antibiotic and corticosteroid combination for

steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular

infection or a risk of bacterial ocular infection exists.

(cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated

with allergic conjunctivitis.

(cyclosporine ophthalmic emulsion) 0.1%, an orphan designated drug that is a calcineurin inhibitor immunosuppressant indicated

for the treatment of vernal keratoconjunctivitis.

(nepafenac ophthalmic suspension) 0.1%, a non-steroidal, anti-inflammatory eye drop indicated for pain and inflammation associated

with cataract surgery.

Preservative Free (PF) is a lubricant eye drop that does not require a prescription and temporarily relieves burning, itching

and other dry eye symptoms.

(neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is an eye drop used to treat steroid-responsive

inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exist.

(dexamethasone ophthalmic suspension) 0.1%, a steroid eye drop for steroid-responsive inflammatory conditions of the palpebral

and bulbar conjunctiva, cornea, and anterior segment of the globe.

1% (apraclonidine hydrochloride), an ophthalmic solution in a sterile isotonic solution indicated to control or prevent

post-surgical elevations in intraocular pressure that occur in patients after argon laser trabeculoplasty, argon laser iridotomy

or Nd:YAG posterior capsulotomy.

0.5% (apraclonidine hydrochloride) an ophthalmic solution indicated for short-term adjunctive therapy in patients on maximally

tolerated medical therapy who require additional intraocular pressure (or IOP) reduction.

also own U.S.

rights to some discontinued products.

In February 2024, we announced that we out-licensed Canadian rights for VERKAZIA,

Cationorm ® PLUS (a preservative-free formulation for dry eye or allergy relief), VEVYE, ZERVIATE and IHEEZO to Apotex

We also own worldwide rights to NATACYN and FRESHKOTE.

ImprimisRx is our ophthalmology-focused

pharmaceutical compounding businesses.

From its inception in 2014, ImprimisRx, whose business consists of integrated research and development,

production, dispensing/distribution, sales, marketing, and customer-service capabilities, has offered ophthalmologist and optometrist

customers and their patients access to critical medicines to meet their clinical needs.

ImprimisRx is focused on compounded medications

to serve needs unmet by commercially available drugs.

Our compounded medications include various combinations of drugs formulated into

one bottle and numerous preservative-free formulations.

Depending on the formulation, the regulations of a specific state, and ultimately

the needs of the patient, ImprimisRx products may be dispensed as patient-specific medications from our 503A pharmacy, or for in-office

use, made according to current good manufacturing practices (“cGMPs”) or other guidance documents from the FDA, in our FDA-registered

New Jersey outsourcing facility.

Our current ophthalmology formulary includes over 30 compounded formulations, many of which are patented

or patent-pending, that are customizable for the specific needs of a patient.

We make our formulations available at prices that are,

in most cases, lower than non-customized commercial drugs.

ImprimisRx’s customer base has grown to include more than 10,000 U.S.

rights to some discontinued products (MOXEZA, VEXOL, ECONOPRED and TOBRASONE).

In February 2024, we announced that we

out-licensed Canadian rights for VERKAZIA, Cationorm ® PLUS (a preservative-free formulation for dry eye or allergy

relief), VEVYE, ZERVIATE and IHEEZO to Apotex Inc.

We also own worldwide rights to NATACYN and

Development Pipeline

development pipeline is focused on developing and commercializing differentiated pharmaceutical therapies designed to address unmet needs

in eye care and selected adjacent markets.

The pipeline is weighted toward late-stage and near-commercial assets with demonstrated clinical

utility and clearer regulatory pathways, and we seek to advance programs through a disciplined, capital-efficient development strategy.

Current development-stage programs include:

(ketamine + midazolam ODT):

completed Phase 3 clinical program;

potential launch in 2028.

MELT-300 is a patented, sublingual/orally

disintegrating tablet that combines a fixed dose of midazolam (3 mg) and ketamine (50 mg) and is designed to provide rapid, predictable

sedation without IV administration, including in cataract and other outpatient procedures.

(triamcinolone acetonide):

current work is focused on chemistry, manufacturing and controls (CMC) optimization, and is expected to

move into the clinic before the end of 2026, with a potential launch in 2028.

H-N08 is an ophthalmic program built around triamcinolone

acetonide intended to support inflammatory indications such as uveitis and/or improve intraoperative visualization in posterior-segment

surgery (e.g., during vitrectomy).

(conjunctival delivery device):

is in the proof-of-concept evaluation stage, with potential launch as early as 2029.

CR-01 is a device-enabled

program intended to deliver therapy via the conjunctiva for ocular neoplasia, a rare disease.

(midazolam ODT):

is currently in clinical development stage;

with a potential launch in 2028.

MELT-210 is a sublingual/orally disintegrating

tablet being developed as a needle-free option for procedural sedation and related anxiolysis/amnesia needs, and has also been used

in MELT-300’s clinical program as a midazolam-only comparator.

timelines and potential launch timing are subject to change based on clinical results, regulatory feedback, manufacturing readiness,

and other factors.

believe MELT-300 represents a transformative opportunity, building on more than a decade of real-world experience with MKO Melt®

— a compounded sublingual sedation product sold by ImprimisRx and currently administered by over 800 U.S.

ophthalmic institutions,

primarily for used for procedural sedation during cataract surgery.

As a potential FDA-approved successor, MELT-300 is a patented, sublingually

delivered formulation of a fixed dose of midazolam (3mg) and ketamine (50mg) designed to provide rapid, predictable sedation without

the need for intravenous administration.

The MELT-300 Phase 2 and Phase 3 clinical programs previously demonstrated statistical superiority

to midazolam alone.

The innovative approach to sedation MELT-300 offers has the potential to transform patient experiences across a wide

range of office-based and outpatient procedures, addressing the healthcare system’s growing demand to reduce exposure to opioids,

including fentanyl.

MELT-300 program was the subject of a Special Protocol Assessment (SPA) with the FDA, confirming that the completed Phase 3 study design,

statistical approach, and endpoints adequately support a future regulatory submission.

Having completed the Phase 3 program, our focus

now turns to advancing MELT-300 toward FDA approval and commercialization.

support of a new drug application (an “NDA”) filing, we recently initiated one non-clinical animal study and three pharmacokinetic

(“PK”) studies to generate the balance of the data we believe is necessary for an NDA package.

Following completion of these

studies, we expect to prepare and submit an NDA for MELT-300 in the first half of 2027.

If promptly approved by the FDA, we expect to

commercially launch MELT-300 in the second half of 2028.

believe these next steps position MELT-300 to become the first FDA-approved, non-opioid, non-IV sublingual sedation therapy in the U.S.,

representing a meaningful growth opportunity for Harrow and a major advancement in patient-centric procedural care.

With patent coverage

and other international markets and potential applications beyond ophthalmology—including gastroenterology, dental

care, and other outpatient settings where sedation or anxiety management may be beneficial, such as diagnostic imaging, endoscopy and

pre-anesthesia—MELT-300 may provide us the opportunity to expand into procedural sedation and anxiety management indications outside

of eye care domestically and in international markets.

is our ophthalmology-focused pharmaceutical compounding business.

Since inception in 2014, ImprimisRx has provided ophthalmologists,

optometrists, and their patients access to compounded medications intended to address needs that may be unmet by commercially available

products, including combination therapies, alternative dosage strengths, and preservative-free formulations.

Depending on formulation,

applicable state requirements, and patient need, ImprimisRx products may be dispensed as patient-specific prescriptions from our 503A

pharmacy or manufactured for in-office use in our FDA-registered 503B outsourcing facility in New Jersey.

Our current ophthalmology formulary

includes over 30 compounded formulations, many of which are patented or patent-pending, and our customer base includes more than 10,000

eyecare-dedicated prescribers and institutions.

Pharmaceutical Compounding

operate two compounding facilities in Ledgewood, New Jersey.

One facility is registered with the FDA as an outsourcing facility under

Section 503B of the Federal Food, Drug and Cosmetic Act (the “FDCA”) (NJOF).

The other facility is a licensed pharmacy operating

under Section 503A of the FDCA (RxNJ).

All compounded products we sell, produce, and dispense are made in the United States.

our current infrastructure supports continued scaling within the current regulatory landscape, and we may pursue additional capacity,

redundancy, and market access through investments, partnerships, or strategic transactions.

Pharmaceutical

compounding is the science of combining different active pharmaceutical ingredients (APIs), all of which are approved by the FDA (either

as a finished form product or as a bulk drug ingredient), and excipients to create specialized pharmaceutical preparations.

and healthcare institutions use compounded drugs when commercially available drugs do not optimally treat a patient’s needs.

many cases, compounded drugs, such as ours, have wide market utility and may be clinically appropriate for large patient populations.

Examples of compounded formulations include medications with alternative dosage strengths or unique dosage forms, such as topical creams

or gels, suspensions, or solutions with more tolerable drug delivery vehicles.

revenue from our compounded products are derived from us making, selling and dispensing our compounded prescription drug formulations

as cash payment transactions between us and our end-user customers.

As such, the majority of our commercial transactions for compounded

products do not involve distributors, wholesalers, insurance companies, pharmacy benefit managers or other middle parties.

to our compounded formulations, by not being reliant on insurance company formulary inclusion and pharmacy benefit manager payment clawbacks,

we are able to simplify the prescription transaction process.

We believe the outcome of our compounding business model is a simple transaction,

involving a patient-in-need, a physician’s diagnosis, a fair price and great service for a quality pharmaceutical product.

ImprimisRx Compounding Facilities

Pharmaceutical compounding businesses

are governed by Sections 503A and 503B of the FDCA.

Section 503A of the Federal Food, Drug and Cosmetic Act (the “FDCA”)

provides that a pharmacy is only permitted to compound a drug for an individually identified patient based on a prescription for the

patient and is only permitted to distribute the drug interstate if the pharmacy is licensed to do so in the states where it is compounded

and where the medication is received.

503B of the FDCA provides that a pharmacy engaged in preparing sterile compounded drug formulations may voluntarily elect to register

as an “outsourcing facility.” Outsourcing facilities are permitted to compound large quantities of drugs without a prescription

and distribute them out of state with certain limitations, such as the formulation appearing on the FDA’s drug shortage list or

the bulk drug substances contained in the formulations appearing on the FDA’s “clinical need” list.

Entities voluntarily

registering with FDA as outsourcing facilities are subject to additional requirements that do not apply to compounding pharmacies (operating

under Section 503A of the FDCA), including adhering to standards such cGMPs or other FDA guidance documents and being subject to regular

FDA inspection.

two compounding facilities located in Ledgewood, New Jersey.

Our New Jersey operations are comprised of two separate entities and facilities,

one of which is registered with the FDA as an outsourcing facility (“NJOF”) under Section 503B of the FDCA.

The other New

Jersey facility (“RxNJ”) is a licensed pharmacy operating under Section 503A of the FDCA.

All of our compounded products

that we sell, produce and dispense are made in the U.S.

that, with our current compounding pharmacy facilities and licenses and FDA registration of NJOF, we have the infrastructure to scale

our business appropriately under the current regulatory landscape and meet the potential growth in demand we are targeting.

invest in one or both of our facilities to further their capacity and efficiencies.

Also, we may seek to access greater pharmacy and

production related redundancy and markets through acquisitions, partnerships or other strategic transactions.

Carved-Out Subsidiaries

(De-Consolidated Businesses)

ownership interests in Melt Pharmaceuticals, Inc.

(“Melt”) and Surface Ophthalmics, Inc.

(“Surface”) and hold

royalty interests in some of Surface’s and Melt’s drug candidates.

These companies are pursuing market approval for their

drug candidates under the FDCA, including in some instances under the abbreviated

pathway described in Section 505(b)(2), which permits the submission of a new drug application (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.

We previously held ownership interest in Eton Pharmaceuticals, Inc.

(“Eton”) and sold

such interests in April 2024.

Melt Pharmaceuticals,

is a clinical-stage pharmaceutical company focused on the development and commercialization of proprietary non-intravenous, sedation

and anesthesia therapeutics for human medical procedures in hospital, outpatient, and in-office settings.

Melt is seeking regulatory

approval for its proprietary technologies, where possible.

is a novel, sublingually delivered, non-IV, opioid-free drug candidate being developed for procedural sedation.

In November 2024, Melt

announced data from, and the successful completion of, its pivotal Phase 3 study for MELT-300.

The MELT-300 pivotal Phase 3 clinical

trial was a randomized, double-blind, three-arm study comparing, at a 4:1:1 ratio, MELT-300, sublingual midazolam, and sublingual placebo,

respectively, for procedural sedation in patients undergoing cataract surgery.

The study was conducted at 13 clinical sites in the U.S.

and enrolled over 530 patients.

Results from the clinical study are summarized below:

achieved its primary procedural sedation endpoint, demonstrating statistical superiority

for procedural sedation compared to all comparator treatment arms, including midazolam 3mg

(P=0.009) and placebo (P<0.001).

the validated Ramsey Sedation Scale (RSS), MELT-300 treatment arm patients were 50% less

likely to require rescue sedation compared to midazolam 3mg (P=0.0198).

of patients requiring rescue sedation was nearly two-fold higher for sublingual midazolam

compared with MELT-300 (P=0.003).

safety profile was generally comparable to the placebo arm.

Phase 3 study was conducted following the successful completion of the MELT-300 Phase 2 clinical trial in patients undergoing cataract

surgery, which compared MELT-300 against (i) sublingual placebo alone, (ii) sublingual midazolam, and (iii) sublingual ketamine in over

300 patients.

MELT-300 was statistically superior for procedural sedation compared to all individual comparator arms:

(i) sublingual

placebo (P<0.0001), (ii) sublingual midazolam (P=0.0129), and (iii) sublingual ketamine (P=0.0096).

2024, Melt reached an agreement with the FDA on a Special Protocol Assessment (“SPA”) for the MELT-300 Phase 3 study.

agreed the study would “adequately address the objectives necessary to support a regulatory submission.” The SPA agreement

establishes a binding agreement on key elements to support a future marketing application.

During 2025, we believe Melt intends to conduct

ancillary studies including a confirmatory pharmacokinetic, hepatic impairment, renal impairment and 28-day toxicity studies.

completion of those ancillary studies, in early 2026, we believe Melt intends to submit an NDA to the FDA for marketing approval of MELT-300.

A final decision regarding marketing approval will be based on the FDA’s review of the full MELT-300 submission package.

require ImprimisRx to cease compounding like products at the time of FDA approval of MELT-300.

December 31, 2024, we owned approximately 45% of Melt’s equity and voting interests issued and outstanding, along with a mid-single

Pharmaceutical

compounding involves preparing customized formulations for patients when commercially available products do not meet a patient’s

clinical needs.

Compounded formulations contain FDA-approved ingredients, but the compounded formulations themselves are not FDA-approved.

Compounding is subject to extensive federal and state regulation and oversight, which can affect permissible activities, cost structure,

and the ability to dispense into particular states.

Subsidiaries (De-Consolidated Businesses)

have an ownership interest in Surface Ophthalmics, Inc.

(“Surface”) and hold royalty interests in some of Surface’s

drug candidates.

Surface is pursuing market approval for its drug candidates under the FDCA, including in some instances under the abbreviated

pathway described in Section 505(b)(2), which permits the submission 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.

We previously

held ownership interests in Eton Pharmaceuticals, Inc.

(“Eton”) and sold the last of our interests in April 2024.

of the Remaining Equity Interests of Melt Pharmaceuticals

to November 2025, we held a minority ownership interest in Melt Pharmaceuticals, Inc.

(“Melt”), a clinical-stage pharmaceutical

company focused on the development and commercialization of proprietary non-intravenous, sedation and anesthesia therapeutics for human

medical procedures in hospital, outpatient, and in-office settings.

Melt sought regulatory approval for its proprietary technologies,

where possible.

of December 31, 2024, we owned approximately 45% of Melt’s equity and voting interests issued and outstanding, along with a mid-single

digit royalty on future net sales of MELT-300.

Surface Ophthalmics,

is a clinical-stage pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular surface

Surface is developing four product candidates for certain ocular surface related indications.

own 3,500,000 shares of Surface common stock, which represented approximately 20% of Surface’s equity and voting interests as

of December 31, 2024.

We own mid-single-digit royalty rights on future net sales of Surface’s drug candidates SURF-100,

SURF-200 and SURF-201.

Eton Pharmaceuticals,

is an innovative pharmaceutical company focused on developing, acquiring, and commercializing treatments for rare diseases.

created and formed as a wholly-owned subsidiary of Harrow.

In May 2017, we gave up our controlling interest in Eton.

In April 2024, we

sold all of our remaining equity interests in Eton which was 1,982,000 shares of common stock in a block trade at a gross price of $3.00

After deducting trading expenses and commissions of approximately $436,000, we received net proceeds of $5,510,000 and recorded

a loss of $3,171,000 related to the sale of our investment in Eton.

Sales and Marketing

The focus of our sales and marketing

is in the U.S.

We do, however, believe that our drug candidates and drug products could have commercial appeal in international markets,

and have engaged distributors and entered into out-licensing arrangements for certain of our products and proprietary formulations in

certain non-U.S.

September 2025, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) by and among Harrow, Harrow Acquisition

Sub, Inc., a wholly owned subsidiary of Harrow, Melt, and D.

Brad Osborne, as stockholder representative.

Under the terms of the Merger

Agreement and a related milestone payment agreement, we agreed to acquire the remaining equity interests of Melt in exchange for an initial

cash payment of approximately $4,300,000 at closing, and contingent consideration consisting of cash and Harrow equity upon achievement

of (i) FDA approval of the MELT-300 product candidate, (ii) coding and reimbursement of the MELT-300 product candidate, and (iii) various

one-time sales milestones.

The regulatory and commercial milestones must be achieved on or before December 31, 2035.

Melt acquisition closed on November 17, 2025, and was treated as an asset acquisition for accounting purposes.

As a result of such

transaction, Melt’s drug candidates are now owned by Harrow and its research and development (“R&D”)

activities subsequent to the acquisition are included in Harrow’s consolidated financial results as of the year ended December

and Marketing

focus of our sales and marketing is in the U.S.

We do, however, believe that our drug candidates and drug products could have commercial

appeal in international markets, and have engaged distributors and entered into out-licensing arrangements for certain of our products

and proprietary formulations in certain non-U.S.

markets, including Canada.

Our sales and marketing activities consist primarily of efforts to educate doctors, ambulatory

surgery centers, healthcare systems, hospitals and other users throughout the U.S.

Our sales and marketing activities consist primarily of efforts

to educate doctors, ambulatory surgery centers, healthcare systems, hospitals and other users throughout the U.S.

about our drug products.

We expect that we may experience

growth in the sales of our products in future periods, particularly in light of our recent product launches and commercial campaigns.

However, we may not be successful in doing so, whether due to the size of the markets for such products, which could be smaller than

we expect, the timing of market entry relative to competitive products, the availability of alternative compounded formulations or FDA-approved

drugs, the price of our products relative to alternative products or the success of our sales and marketing efforts, which is dependent

on our ability to further build and continue to grow a qualified and adequate internal sales function.

to continue to acquire and/or develop additional FDA-approved ophthalmic products that allow us to leverage our existing commercial infrastructure

We expect that we may experience growth in the sales of our products in future periods, particularly in light of our recent product launches

and commercial campaigns.

However, we may not be successful in doing so, whether due to the size of the markets for such products, which

could be smaller than we expect, the timing of market entry relative to competitive products, the availability of alternative compounded

formulations or FDA-approved drugs, the price of our products relative to alternative products or the success of our sales and marketing

efforts, which is dependent on our ability to further build and continue to grow a qualified and adequate internal sales function.

expect to continue to acquire and/or develop additional FDA-approved products that allow us to leverage our existing commercial infrastructure

to promote, sell, and ultimately bring these products to market.

1 unchanged sentence

marketing team, expertise and expenses.

Supply Chains

of our ImprimisRx finished compounded products are made in the U.S.

at our compounding facilities located in New Jersey.

not manufacture any of our branded pharmaceutical products and rely on third party manufacturing partners to make these finished goods.

do not manufacture any of our branded pharmaceutical products and rely on third party manufacturing partners to make finished goods.

The following table describes by product the country where our finished branded products are made.

Country Finished Product Is Manufactured

Ophthalmology Market

For any ocular procedure, a surgeon

may require drugs for sedation, dilation, anesthesia, inflammation and infection prevention, and ocular surface preservation.

surgery market continues to experience significant growth.

According to Market Scope , approximately 4.8 million lens procedures

were performed in the U.S.

in 2021, 97% of which were cataracts, with the number expected to grow to 5.5 million lens procedures in 2026.

Nearly 96% of the refractive surgery procedures performed are LASIK (laser in situ keratomileusis) surgeries, an outpatient surgical

procedure used to treat nearsightedness, farsightedness, and astigmatism.

According to an article published in 2021 in Clinical Ophthalmology ,

an estimated 800,000 eyes were treated with laser correction surgery (such as LASIK) each year for the previous ten years.

Dry eye occurs when the eye does

not produce enough tears, or when the tears are not of the correct consistency and evaporate too quickly.

Inflammation of the surface

of the eye may also occur.

According to a 2023 Market Scope report, there are 39 million people in the U.S.

that suffer from both

signs and symptoms of dry eye, with 49% of diagnosed dry eye patients having moderate to severe dry eye.

The same report stated the global

dry eye product market is expected to grow from $5.8 billion in 2023 to $7.5 billion in 2028.

Dry eye is among the most common conditions

seen by eyecare professionals.

injections are one of the most common procedures performed by ophthalmologists in the U.S.

According to a 2023 article published in

Healio , approximately 8 million intravitreal injections were expected to be performed that year.

These injections are utilized

to administer critical medications into the eye that treat diseases including but not limited to proliferative diabetic retinopathy,

diabetic macular edema, wet age-related macular degeneration, neovascular glaucoma, retinal vein occlusions, intraocular tumors, and

endophthalmitis.

In addition, products and product candidates are being developed and used to treat symptoms associated with an eye disease

known as geographic atrophy.

Most of the medicines in these products and product candidates are administered via intravitreal injection.

Therefore, we believe as these products and product candidates gain commercial adoption, the number of annual intravitreal injections

should increase further and at an increased rate as compared to recent years.

is a surgical procedure undertaken by a specialist where the vitreous humor gel that fills the eye cavity is removed to provide better

access to the retina.

This allows for a variety of repairs, including the removal of scar tissue, laser repair of retinal detachments

and treatment of macular holes.

According to data from Definitive Health from 2023, U.S.

surgeons perform about 420,000 vitrectomies

The number is likely to continue to grow as eye care providers find more uses for vitrectomy.

non-infectious uveitis affecting the posterior segment of the eye is an inflammatory disease that afflicts people of all ages, producing

swelling and destroying eye tissues, which can lead to severe vision loss and blindness.

Based on internal estimates and information

published on the MedScape website (which was updated as of March 2023) that cites various ranges of prevalence of uveitis, we estimate

this disease affects approximately 100,000 people each year in the U.S.

The standard of care treatment for this disease typically involves

the use of short-acting corticosteroids to reduce uveitic flares (such as TRIESENCE) followed by additional treatments of sustained release,

lower dose steroids to minimize the risk of further flares.

The pharmaceutical and pharmacy

industries are highly competitive.

We compete against branded drug companies, generic drug companies, outsourcing facilities and compounding

We are smaller than some of our competitors, and we may lack the financial and other resources needed to develop, produce,

distribute, market and commercialize any of our branded products and proprietary formulations or compete for market share in these sectors.

The drug products available through branded and generic drug companies with which our products and formulations compete have been approved

for marketing and sale by the FDA and are required to be manufactured in facilities compliant with cGMP standards.

Although we prepare

some of our compounded formulations in accordance with cGMP standards and our other formulations are produced according to the standards

provided by U.S.

Pharmacopoeia (USP) Chapter <795> (“USP 795”) and USP Chapter <797> (“USP 797”)

and applicable state and federal law, our compounded formulations are not required to be, and have not been, approved for marketing and

sale by the FDA.

As a result, some physicians may be unwilling to prescribe, and some patients may be unwilling to use, our compounded

formulations.

Additionally, under federal and state laws applicable to our current compounding pharmacy operations operating under Section

503A of the FDCA, we are not permitted to prepare significant amounts of a specific formulation in advance of a prescription, compound

quantities for office use or utilize a wholesaler for distribution of our formulations;

instead, our compounded formulations must be

prepared and dispensed in connection with a physician prescription for an individually identified patient.

Pharmaceutical companies,

on the other hand, are able to sell their FDA-approved products to large pharmaceutical wholesalers, who can in turn sell to and supply

hospitals and retail pharmacies.

Even though we have registered NJOF with the FDA, our compounding business may not be scalable on the

scope available to our competitors that produce FDA-approved drugs, which may limit our potential for profitable operations.

of our operations may subject our business to limitations our competitors offering only FDA-approved drugs may not face.

Biotechnology and related pharmaceutical

technologies are subject to rapid and significant change.

Our future success will depend in large part on our ability to maintain a competitive

position with respect to these technologies.

Products developed by our competitors, including FDA-approved drugs and compounded formulations

created by other pharmacies, could render our products and technologies obsolete or unable to compete.

Any products that we develop may

become obsolete before we recover expenses incurred in developing the products, which may require that we seek additional funds that

may or may not be available to continue our operations.

The competitive environment requires an ongoing, extensive search for medical

and technological innovations and the ability to develop and market these innovations effectively, and we may not be competitive with

respect to these factors.

Other competitive factors include the safety and efficacy of a product, the size of the market for a product,

the timing of market entry relative to competitive products, the availability of alternative compounded formulations or approved drugs,

the price of a product relative to alternative products, the availability of third-party reimbursement, the success of sales and marketing

efforts, brand recognition and the availability of scientific and technical information about a product.

Although we believe we are positioned

to compete favorably with respect to many of these factors, if our proprietary formulations are unable to compete with the products of

our competitors, we may never gain a significant market share or achieve profitability.

Factors Affecting Our Performance

the primary factors affecting our performance are our ability to increase revenues of our ophthalmic products, grow and gain operating

efficiencies in our pharmacy operations, successfully adjust our operations to account for any future regulatory-related restrictions,

In some instances, multiple countries

are listed to reflect either (i) expected changes in our contract manufacturer and location;

and (ii) in certain cases, to reflect the

country of a second contract manufacturer site:

Finished Product Is Manufactured

by end of 2026 production is expected to be in Taiwan

by end of 2026 production is expected to be in Spain

by end of 2026 production is expected to be in Belgium

by end of 2026 production is expected to be in Spain

by end of 2026 production is expected to be in Belgium

Ophthalmology

pharmaceuticals are used across several major categories of eye care, including high-volume procedures (such as cataract/lens procedures

and refractive surgeries like LASIK), chronic ocular surface conditions (including dry eye disease), retina disease management (often

involving physician-administered therapies delivered by intravitreal injection), and posterior-segment surgical care (including vitrectomy

and related visualization and inflammation management).

These settings drive demand for different classes of ophthalmic products—such

as anesthetics, anti-infectives, anti-inflammatories (including corticosteroids and NSAIDs), immunomodulators, and ocular surface lubricants—used

before, during, and after procedures and for ongoing disease management.

Utilization across these categories is influenced by procedure

volumes and clinical practice patterns, the availability of therapeutic alternatives (including generics and biosimilars), and market

access factors such as formulary placement, prior authorization/step therapy, reimbursement, and patient out-of-pocket costs.

Our portfolio

is focused on these major ophthalmic categories and spans products used in ocular surface disease, perioperative care, posterior-segment

surgical and retina settings.

We have limited exposure to glaucoma therapies.

pharmaceutical industry is highly competitive.

We compete with branded and generic pharmaceutical companies, biosimilar manufacturers,

and other companies developing or commercializing ophthalmic therapies, including products used in ocular surface disease, perioperative

care, and retina.

Certain competitors have substantially greater financial, technical, manufacturing, and commercial resources than we

do, and may be able to develop, obtain regulatory approval for, manufacture, market, and sell products more effectively than we can,

including through larger sales forces, broader distribution networks, and greater access to capital.

As a result, we may face competitive

disadvantages in gaining or maintaining market share, achieving favorable formulary placement and reimbursement, securing manufacturing

capacity and supply chain reliability, and sustaining pricing and margins.

Biotechnology

and pharmaceutical technologies are subject to rapid and significant change.

Our success depends in part on our ability to maintain a

competitive position with respect to new therapies, delivery methods, and competitive entrants, including generics and biosimilars.

may introduce products that are safer, more effective, easier to use, more durable, more convenient, or more cost-effective than our

products, or that achieve greater market access through reimbursement or contracting advantages.

New competitive products could reduce

demand for, or the market opportunity of, our existing products and could render our product candidates or lifecycle management initiatives

less attractive or commercially viable before we recover development or commercialization investments.

also depends on factors such as clinical performance, physician adoption and practice patterns, timing of market entry, regulatory developments,

product availability and supply reliability, pricing and patient affordability, third-party reimbursement, and the effectiveness of sales,

marketing, and distribution efforts.

If we are unable to compete effectively with current or future products of our competitors, our

revenues, profitability, and growth prospects could be materially and adversely affected.

the extent we offer compounded formulations through our pharmacy operations, those products also face competition from FDA-approved alternatives

and other compounded products, and utilization may be affected by physician and patient preferences and applicable regulatory requirements.

Affecting Our Performance

believe the primary factors affecting our performance are our ability to increase revenues of our ophthalmic products, grow and gain

operating efficiencies in our pharmacy operations, successfully adjust our operations to account for any future regulatory-related restrictions,

optimize pricing and obtain reimbursement options for our ophthalmic products, and continue to pursue development and commercialization

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operations or other sources.

See “Liquidity and Capital Resources” below.

Medicare, Medicaid and Other Reimbursement Options

“Management’s Discussion and Analysis of Financial Condition and Result of Operations

- Liquidity and Capital Resources.”

Medicaid and Other Reimbursement Options

of our marketed products are dependent, in large part, on the availability and extent of reimbursement from third-party payors,

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“Risk Factors” for risks related to reimbursement and government

We participate

in, and have certain price reporting obligations to, the Medicaid Drug Rebate program, state Medicaid supplemental rebate program(s),

and other governmental pricing programs.

We also have obligations to report the average sales price for certain drugs to the Medicare

Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient

drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being

made available for our drugs under Medicaid and Part B of the Medicare program.

participate in, and have certain price reporting obligations to, the Medicaid Drug Rebate program, state Medicaid supplemental rebate

program(s), and other governmental pricing programs.

We also have obligations to report the average sales price for certain drugs to

the Medicare program.

Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our

covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having

federal funds being made available for our drugs under Medicaid and Part B of the Medicare program.

is a federal program that is administered by the federal government that covers individuals age 65 and over or that are disabled as well

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other legislative change could impact the market conditions for our products.

and TRIESENCE are covered under Medicare Part B and we may develop other product candidates and/or acquire drug products that are

also covered under Medicare Part B.

In February 2023, we announced that CMS had issued a permanent, product specific J-code for

IHEEZO (J2403) which became effective under the Healthcare Procedure Coding System (HCPCS) on April 1, 2023.

TRIESENCE has a

permanent product specific J-code (J3300) as well, which physicians can use for reimbursement purposes of that product.

approved by the FDA that are used in surgeries performed in a hospital outpatient departments or ambulatory surgical centers may

receive a transitional pass-through reimbursement under Medicare, provided they meet certain criteria, including a “not

insignificant” cost criterion.

Pass-through status allows for separate payment (i.e., outside the packaged payment rate for

the surgical procedure) under Medicare Part B, which consists of Medicare reimbursement for a drug based on a defined formula for

calculating the minimum fee that a manufacturer may charge for the drug.

Under current regulations of CMS, pass-through status

applies for a period of three years;

OPUVIZ, IHEEZO and TRIESENCE are covered under Medicare Part B and we are developing other product candidates and may acquire drug products

that are also covered under Medicare Part B.

In February 2023, we announced that CMS had issued a permanent, product specific J-code

for IHEEZO (J2403) which became effective under the Healthcare Procedure Coding System (HCPCS) on April 1, 2023.

TRIESENCE has a permanent

product specific J-code (J3300) as well, which physicians can use for reimbursement purposes of that product.

Similarly, BYOOVIZ and

OPUVIZ have permanent product specific reimbursement codes of Q5124 and Q5153, respectively, which healthcare professionals can use for

reimbursement of those biosimilar products.

drugs approved by the FDA that are used in surgeries performed in a hospital outpatient departments or ambulatory surgical centers may

receive a transitional pass-through reimbursement under Medicare, provided they meet certain criteria, including a “not insignificant”

cost criterion.

Pass-through status allows for separate payment (i.e., outside the packaged payment rate for the surgical procedure)

under Medicare Part B, which consists of Medicare reimbursement for a drug based on a defined formula for calculating the minimum fee

that a manufacturer may charge for the drug.

Under current regulations of CMS, pass-through status applies for a period of three years;

which is measured from the date Medicare makes its first pass-through payment for the product.

Following the three-year period, the product would be incorporated into the cataract bundled payment system, which could

significantly reduce the pricing for that product.

Temporary pass-through reimbursement for IHEEZO was awarded by CMS and made

effective in the second quarter of 2023 and temporary pass-through reimbursement for TRIESENCE was made effective April 1, 2025.

Following the expiration of pass-through status, under current CMS policy, non-opioid pain

management surgical drugs when used on Medicare Part B patients in an outpatient setting can qualify for ongoing separate payments.

CMS’ current non-opioid separate payment policy, like other CMS policies, can be changed by CMS through its annual rulemaking

and comment process.

Following the three-year period, the product

would be incorporated into the cataract bundled payment system, which could significantly reduce the pricing for that product.

pass-through reimbursement for IHEEZO was awarded by CMS and made effective in the second quarter of 2023 and temporary pass-through

reimbursement for TRIESENCE was made effective April 1, 2025.

We expect pass-through status for IHEEZO to expire March 31, 2026.

the expiration of pass-through status, under current CMS policy, non-opioid pain management surgical drugs when used on Medicare Part

B patients in an outpatient setting can qualify for ongoing separate payments.

CMS’ current non-opioid separate payment policy,

like other CMS policies, can be changed by CMS through its annual rulemaking and comment process.

is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries.

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removed, and our rebate liability could increase accordingly.

become aware that our reporting for a prior quarter was incorrect or has changed as a result of recalculation of the pricing data, we

are obligated to resubmit the corrected data for up to three years after those data originally were due, which revisions could affect

we become aware that our reporting for a prior quarter was incorrect or has changed as a result of recalculation of the pricing data,

we are obligated to resubmit the corrected data for up to three years after those data originally were due, which revisions could affect

our rebate liability for prior quarters.

44 unchanged sentences

manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.

to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain

federal agencies and grantees, we participate in the U.S.

Department of Veterans Affairs (“VA”) Federal Supply Schedule (“FSS”)

pricing program.

FSS participation is required for our products to be purchased by the VA, Department of Defense (“DoD”),

Coast Guard, and Public Health Service (“PHS”).

Prices for innovator drugs purchased by the VA, DoD, Coast Guard, and PHS

are subject to a cap (known as the “Federal Ceiling Price”) equal to 76% of the annual non-federal average manufacturer price

(“non-FAMP”) minus, if applicable, an additional discount.

The additional discount applies if non-FAMP increases more than

inflation (measured by reference to the Consumer Price Index - Urban).

We also participate in the Tricare Retail Pharmacy Program, under

which we pay quarterly rebates to DoD for prescriptions of our innovator drugs dispensed to Tricare beneficiaries through Tricare Retail

network pharmacies.

The governing statute provides for civil monetary penalties for failure to provide information timely or for knowingly

submitting false information to the government.

order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by

certain federal agencies and grantees, we participate in the U.S.

Department of Veterans Affairs (“VA”) Federal Supply Schedule

(“FSS”) pricing program.

FSS participation is required for our products to be purchased by the VA, Department of Defense

(“DoD”), Coast Guard, and Public Health Service (“PHS”).

Prices for innovator drugs purchased by the VA, DoD,

Coast Guard, and PHS are subject to a cap (known as the “Federal Ceiling Price”) equal to 76% of the annual non-federal average

manufacturer price (“non-FAMP”) minus, if applicable, an additional discount.

The additional discount applies if non-FAMP

increases more than inflation (measured by reference to the Consumer Price Index - Urban).

We also participate in the Tricare Retail

Pharmacy Program, under which we pay quarterly rebates to DoD for prescriptions of our innovator drugs dispensed to Tricare beneficiaries

through Tricare Retail network pharmacies.

The governing statute provides for civil monetary penalties for failure to provide information

timely or for knowingly submitting false information to the government.

Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that are not administered by a physician).

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reimburse for use of our products or may do so at levels that disadvantage them relative to competitive products.

Intellectual Property

Our success and ability to compete

depends upon our ability to protect our intellectual property.

We conduct a fulsome analysis of the intellectual property landscape prior

to acquiring rights to formulations and filing patent applications.

In addition, as of March 1, 2025, we owned and/or licensed more than

50 total issued and pending patent applications, which include U.S.-issued patents, international-issued patents, and U.S.

and foreign/international

patent pending applications.

success and ability to compete depends upon our ability to protect our intellectual property.

We conduct a fulsome analysis of the intellectual

property landscape prior to acquiring rights to formulations and filing patent applications.

In addition, as of March 2, 2026, we owned

and/or licensed more than 50 issued and pending patent applications, which include U.S.-issued patents, international-issued patents,

and foreign/international patent pending applications.

We expect to file additional patent applications in the U.S.

and pursue patent protection for certain of

our formulations in other important international jurisdictions in the future.

As of March 1, 2025, we had,

on a worldwide basis, more than 100 issued trademarks, pending trademark and copyright applications, or registered copyrights and/or

We also rely on unpatented trade secrets and know-how and continuing technological innovation in order to develop our products

and formulations, which we seek to protect, in part, by confidentiality agreements with our employees, consultants, collaborators and

others, including certain service providers.

We also have invention or patent assignment agreements with our current employees and certain

However, our employees and consultants may breach these agreements, and we may not have adequate remedies for any breach,

or our trade secrets may otherwise become known or be independently discovered by competitors.

In addition, inventions relevant to us

could be developed by a person not bound by an invention assignment agreement with us, in which case we may have no rights to use the

applicable invention.

following table lists our outstanding material patents in the U.S.

for certain branded products, general subject matter and latest expiry

One or more patents with the same or earlier expiry dates may fall under the same general subject matter and are not listed separately.

General Subject Matter

Methods using topical formulations

Compositions compromising chloroprocaine

September 2038

Formulation composition for treatment of dry

Ophthalmic composition comprising cyclosporine

Semiflourinated compounds for ophthalmic administration

Topical administration method

December 2030

September 2037

November 2038

Composition of injectable suspension

Methods for treating ophthalmic disorder

December 2029

Composition comprising carbomer, galactomannan and borate

Carboxyvinyle polymer-containing nanoparticle suspension

December 2030

Methods for treating inflammation where infection may occur

Compositions containing tobramycin and dexamethasone

December 2027

Methods for treating eye disease

Compositions of oil-in-water cationic emulsion

Compositions containing quaternary ammonium compounds

November 2027

Governmental Regulation

Our business is subject to federal,

state and local laws, regulations, and administrative practices, including, among others:

federal, state and local licensure and registration

requirements concerning the operation of pharmacies and the practice of pharmacy;

the Health Insurance Portability and Accountability

Act of 1996 (“HIPAA”);

patent protection for certain of our formulations in other important international jurisdictions in the future.

of March 2, 2026, we had, on a worldwide basis, more than 100 issued trademarks, pending trademark and copyright applications, or registered

copyrights and/or trademarks.

We also rely on unpatented trade secrets and know-how and continuing technological innovation in order

to develop our products and formulations, which we seek to protect, in part, by confidentiality agreements with our employees, consultants,

collaborators and others, including certain service providers.

We also have invention or patent assignment agreements with our current

employees and certain consultants.

However, our employees and consultants may breach these agreements, and we may not have adequate remedies

for any breach, or our trade secrets may otherwise become known or be independently discovered by competitors.

In addition, inventions

relevant to us could be developed by a person not bound by an invention assignment agreement with us, in which case we may have no rights

to use the applicable invention.

following table lists some of our outstanding material patents in the U.S.

covering certain branded products we own commercial rights

to, general subject matter and latest expiry date.

One or more patents with the same or earlier expiry dates may fall under the same

general subject matter and are not listed separately.

Subject Matter

using topical formulations

comprising chloroprocaine

composition for treatment of dry eye syndrome

composition comprising cyclosporine

Semiflourinated

compounds for ophthalmic administration

administration method

of injectable suspension

for treating ophthalmic disorder

comprising carbomer, galactomannan and borate

Carboxyvinyle

polymer-containing nanoparticle suspension

suspension comprising nanoparticles

method of treating an eye inflammatory or infectious disease

for treating eye disease

of oil-in-water cationic emulsion

containing quaternary ammonium compounds

business is subject to federal, state and local laws, regulations, and administrative practices, including, among others:

federal, state

and local licensure and registration requirements concerning the operation of pharmacies and the practice of pharmacy;

the Health Insurance

Portability and Accountability Act of 1996 (“HIPAA”);

the Health Care Reform Law;

statutes and regulations of the FDA, the U.S.

Federal Trade Commission

(the “FTC”), the U.S.

statutes and regulations of the FDA, the

Federal Trade Commission (the “FTC”), the U.S.

Drug Enforcement Administration and the U.S.

Consumer Product Safety Commission, as well as regulations

promulgated by comparable state agencies concerning the sale, advertisement and promotion of the products we sell.

The regulatory and

quality compliance environment for compounded drugs has become significantly more rigorous, complex and strict since the passage of The

Drug Quality and Security Act of 2013 (the “DQSA”).

The complexity of the current state and federal regulatory environment,

as well as the expected continued evolution of state and federal laws governing pharmaceutical compounding, have presented, and will

continue to present, potentially significant challenges to our business model and the fulfillment of our mission as a company.

are descriptions of some of the various federal and state laws and regulations which may govern or impact our current and planned operations.

FDA New Drug Application (NDA)

As discussed in other sections

of this Annual Report, we are pursuing, and may continue to pursue, alone or with project partners, FDA approval to market and sell one

or more of our product candidates through the FDA’s NDA process.

As a condition of approval, the FDA or other regulatory authorities

may require further studies, including Phase 4 post-marketing studies, to provide additional data.

What changed 10-K

Item 1. Business