NASDAQ: HROW

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

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VEVYE®
(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.

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TRIESENCE®
(triamcinolone acetonide injectable suspension) 40 mg/ml, a steroid injection for the treatment of certain ophthalmic diseases
and for visualization during vitrectomy.

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BYOOVIZ®
(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
(mCNV). We expect to commercially launch BYOOVIZ in mid-2026.

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OPUVIZ®
(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.

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BYQLOVITM
(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. We expect
to commercially launch BYQLOVI in mid-2026.

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VIGAMOX®
(moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial
conjunctivitis caused by susceptible strains of organisms.

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ILEVRO®
(nepafenac ophthalmic suspension) 0.3%, a non-steroidal, anti-inflammatory eye drop indicated for pain and inflammation associated
with cataract surgery.

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FLAREX®
(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.

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NATACYN®
(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.

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TOBRADEX®
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.

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ZERVIATE®
(cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated
with allergic conjunctivitis.

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VERKAZIA®
(cyclosporine ophthalmic emulsion) 0.1%, an orphan designated drug that is a calcineurin inhibitor immunosuppressant indicated
for the treatment of vernal keratoconjunctivitis.

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NEVANAC®
(nepafenac ophthalmic suspension) 0.1%, a non-steroidal, anti-inflammatory eye drop indicated for pain and inflammation associated
with cataract surgery.

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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.

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MAXITROL®
(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.

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MAXIDEX®
(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.

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IOPIDINE®
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.

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IOPIDINE®
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.

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We
also own 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. (“Apotex”). We also own worldwide rights to NATACYN and
FRESHKOTE.

R&D
Development Pipeline

Our
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:

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MELT-300
(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.

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H-N08
(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).

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CR-01
(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.

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MELT-210
(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.

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

MELT-300

We
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.

The
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.

In
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.

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We
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
in the U.S. 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.

ImprimisRx

ImprimisRx
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
U.S. eyecare-dedicated prescribers and institutions.

We
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. We believe
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

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.

Carved-Out
Subsidiaries (De-Consolidated Businesses)

We
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.

Acquisition
of the Remaining Equity Interests of Melt Pharmaceuticals

Prior
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.

As
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.

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In
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.

The
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
31, 2025.

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. 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. 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.

We
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. As we execute this strategy, we will continue to expand our sales and
marketing team, expertise and expenses.

Supply
Chains

100%
of our ImprimisRx finished compounded products are made in the U.S. at our compounding facilities located in New Jersey.

We
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. 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:

Product

Country
Finished Product Is Manufactured

IHEEZO

France

VEVYE

U.S.
and Spain

TRIESENCE

U.S.

VIGAMOX

Belgium

ILEVRO

Belgium

FLAREX

U.S.,
by end of 2026 production is expected to be in Taiwan

NATACYN

U.S.

TOBRADEX
ST

U.S.;
by end of 2026 production is expected to be in Taiwan

ZERVIATE

France;
by end of 2026 production is expected to be in Spain

VERKAZIA

France

NEVANAC

U.S.;
by end of 2026 production is expected to be in Belgium

FRESHKOTE

France;
by end of 2026 production is expected to be in Spain

MAXIDEX

U.S.;
by end of 2026 production is expected to be in Belgium

MAXITROL

Belgium

IOPIDINE
1%

France

BYQLOVI

Taiwan

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Ophthalmology
Market

Ophthalmic
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.

Competition

The
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. Competitors
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.

Competition
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.

To
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.

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Factors
Affecting Our Performance

We
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
opportunities for certain of our ophthalmology and other assets that we have not yet made commercially available or have been recently
launched. We believe we have built a tangible and intangible infrastructure that will allow us to scale revenues efficiently in the near
and long-term. All of these activities will require increased costs and other resources, which we may not have or be able to obtain from
operations or other sources. See Item 7. “Management’s Discussion and Analysis of Financial Condition and Result of Operations
- Liquidity and Capital Resources.”

Medicare,
Medicaid and Other Reimbursement Options

Sales
in the U.S. of our marketed products are dependent, in large part, on the availability and extent of reimbursement from third-party payors,
including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid. See