One To Watch
Harrow
Company Overview
A Nashville-based ophthalmic pharmaceutical company that has built one of the broadest US eyecare portfolios — spanning FDA-approved branded drugs, compounded products, and an active pipeline — through a deliberate acquisition-led strategy targeting underleveraged ophthalmic assets. Trading on Nasdaq as HROW, Harrow, Inc. reaffirmed 2025 full-year revenue guidance of $270-280 million in February 2026, a figure that underlines how quickly the commercial model has scaled. The company operates across two distinct channels: its ImprimisRx ophthalmic compounding business and a growing branded portfolio built largely through in-licensing and acquisition from larger pharma players exiting niche eye categories.
Headquarters and Global Presence
Harrow is headquartered in Nashville, Tennessee, and operates primarily within the US market. Its commercial infrastructure covers both compounded and FDA-approved ophthalmic products, distributed nationally through ImprimisRx and its branded sales force.
Founding and History
Founded in 2011, Harrow pivoted exclusively to ophthalmology in 2014 and reached a structural milestone in 2021 as the first US ophthalmic company to offer both compounded and FDA-approved products simultaneously. The company formally rebranded from Harrow Health, Inc. to Harrow, Inc. in 2023, signaling a sharpened identity around eyecare pharmaceuticals. A pivotal moment came in 2023 when Harrow acquired US commercial rights to five FDA-approved ophthalmic products from Novartis — a deal that produced a 15% single-day share price gain and meaningfully widened the branded portfolio.
Therapy Areas and Focus
Harrow's portfolio addresses a range of ocular conditions across allergy, dry eye, inflammation, anesthesia, and surgical visualization — segments where specialist attention from large pharma has historically been inconsistent. Vernal keratoconjunctivitis, targeted by Verkazia, is a rare and serious allergic eye disease where access has been a persistent barrier for pediatric patients. IHEEZO fills a specific procedural need as the only needle-free ocular anesthetic approved for cataract and retinal surgery in the US, a workflow-improvement argument that has driven payer coverage above 90%.
Technology Platforms and Modalities
Harrow's model is less about novel mechanism discovery and more about acquiring, repositioning, and extending the commercial life of proven ophthalmic formulations. IHEEZO (chloroprocaine hydrochloride gel 3%) delivers topical anesthesia without injection, addressing both patient comfort and procedural efficiency — and carries patent protection to 2037, providing a durable commercial runway. Through its relationship with Melt Pharmaceuticals, Harrow is also moving into sublingual sedation for in-office ophthalmic procedures, a modality that could further reduce the need for intravenous anesthesia in outpatient settings.
Key Pipeline and Programs
TRIESENCE (triamcinolone acetonide injectable suspension 40 mg/mL) is the most advanced pipeline asset. Harrow received FDA IND clearance for a Phase III trial investigating TRIESENCE for ocular inflammation and pain following cataract surgery; study initiation was expected in Q1 2026, with enrollment from Q2 2026. This is a significant expansion beyond TRIESENCE's current approved uses in uveitis and vitrectomy visualization.
IHEEZO is the subject of a Harrow-sponsored Phase II study with a readout expected by end of 2026. The trial is expected to generate data supporting label expansion or new procedural indications for the chloroprocaine gel, building on an existing commercial base with strong payer access.
Via Melt Pharmaceuticals, Harrow is advancing MELT-300 and MELT-210 — sublingual sedation agents — toward NDA submission. The G-Melt NDA submission is targeted for early 2027. These assets address pre-procedural anxiolysis for ophthalmic office procedures, a gap in the current standard of care that could open a new product category for Harrow's commercial team.
Recent Developments
The most market-moving recent event was the June 10, 2026 re-launch of Verkazia (cyclosporine ophthalmic emulsion 0.1%) for vernal keratoconjunctivitis, which sent Harrow shares up 9% to $36.47 on the day — a reaction that reflects investor appetite for any expansion of the rare-disease portion of the portfolio. In July 2025, Samsung Bioepis entered a license, development, and commercialization agreement with Harrow covering Samsung Bioepis' ophthalmology biosimilar portfolio in the US, a deal that could add meaningful long-term revenue if ophthalmic biosimilars gain traction against branded anti-VEGF agents. TRIESENCE had previously been relaunched in late 2024 following supply-chain disruptions, returning a key surgical visualization product to full availability.
Key Personnel
Mark L. Baum serves as Chief Executive Officer, having led Harrow since its founding and architected the pivot to an exclusively ophthalmic focus. Andrew R. Boll serves as Chief Financial Officer, overseeing the financial strategy behind Harrow's acquisition-driven growth. The company's leadership team has been central to executing deal-making with counterparties including Novartis and Samsung Bioepis.
Strategic Partnerships
The Samsung Bioepis partnership, announced July 2025, gives Harrow US commercialization rights to Samsung's ophthalmology biosimilar portfolio — positioning the company ahead of anticipated biosimilar competition in the ophthalmic biologics space. Harrow's 2023 acquisition of five FDA-approved products from Novartis — including Verkazia and VEVYE — remains the single largest portfolio-shaping transaction in the company's history. The Melt Pharmaceuticals relationship adds a pipeline dimension focused on in-office procedural sedation, with NDA submissions targeted from early 2027.
FAQ Section
Harrow's model centers on acquiring under-commercialized or divested ophthalmic assets from larger pharma companies and relaunching them with focused US distribution. Rather than funding early-stage discovery, Harrow deploys capital toward licensing and M&A — the Novartis five-product deal in 2023 and the Samsung Bioepis biosimilar partnership in 2025 are the clearest expressions of this. The strategy produces faster revenue visibility but depends on continued deal flow and the company's ability to extract commercial value that larger players left on the table.
VKC is a rare, chronic allergic eye disease affecting predominantly children and young adults, with limited approved treatment options in the US. Verkazia (cyclosporine ophthalmic emulsion 0.1%) holds FDA approval for this indication, placing it in an orphan-adjacent commercial category where specialist prescribing and patient access programs can drive outsized returns relative to market size. The 9% share price reaction on the day of Verkazia's June 2026 re-launch suggests investors view rare ophthalmic disease as a meaningful growth vector for Harrow.
IHEEZO (chloroprocaine hydrochloride gel 3%) is the only FDA-approved needle-free ocular anesthetic for use in cataract and retinal procedures in the US. Eliminating the injection step addresses a tangible workflow and patient-comfort concern in high-volume surgical settings. With payer coverage exceeding 90% and patent protection running to 2037, IHEEZO carries a durable commercial position that is difficult to replicate quickly — and an ongoing Phase II study could extend its label further.
TRIESENCE is a triamcinolone acetonide injectable suspension (40 mg/mL) currently approved for uveitis management and visualization during vitrectomy. Harrow received FDA IND clearance for a Phase III trial in ocular inflammation and pain following cataract surgery — a much larger patient population than the existing label covers, given that cataract surgery is among the most commonly performed procedures in the US. Enrollment was expected to begin from Q2 2026, making this the most proximate late-stage clinical catalyst on Harrow's timeline.
The portfolio spans dry eye (VEVYE), ocular allergy (Verkazia), surgical anesthesia (IHEEZO), post-surgical inflammation (TRIESENCE), and potentially procedural sedation via the Melt Pharmaceuticals sublingual pipeline. The unifying logic is the ophthalmology procedure suite and specialist prescriber base — each product touches either the ophthalmic surgeon or the cornea/anterior segment specialist. This concentration on a defined customer means Harrow's commercial infrastructure can cross-promote across indications without the cost of building multiple disease-specific sales organizations.
Harrow is primarily a commercial-stage company with an active late-stage pipeline layer. The near-term clinical milestones include the IHEEZO Phase II readout expected by end of 2026 and TRIESENCE Phase III enrollment through 2026. On the regulatory side, the G-Melt NDA submission (sublingual sedation via Melt Pharmaceuticals) is targeted for early 2027. The Samsung Bioepis ophthalmic biosimilar partnership represents a longer-horizon revenue stream dependent on biosimilar uptake in the anti-VEGF market.
Key catalysts and watchpoints include:
- IHEEZO Phase II readout by end of 2026: positive data could support label expansion and further justify premium pricing against payers.
- TRIESENCE Phase III enrollment progress: successful initiation would validate the cataract surgery opportunity and open a substantially larger addressable market.
- G-Melt NDA submission in early 2027: FDA acceptance and review timeline will determine whether in-office sedation becomes a meaningful revenue contributor.
- Samsung Bioepis biosimilar partnership: ophthalmic biosimilar uptake has been slower than systemic markets; the commercial timeline here is genuinely uncertain.
- Revenue guidance execution: sustaining the $270-280 million trajectory while integrating new launches (Verkazia, potential biosimilars) is operationally complex.
- Deal dependency: the acquisition-led model requires continued availability of attractive ophthalmic assets at prices that preserve margin — a risk that grows as the company's profile rises.
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