Harrow reported third-quarter 2025 revenue of $71.6 million, up 45% year over year, returning to GAAP profitability with $1.0 million in net income and posting adjusted EBITDA of $22.7 million. The company highlighted new commercial momentum across its ophthalmic portfolio, including impending preferred formulary placement for Vevye beginning January 1, 2026, a broader patient access infrastructure via its Harrow Access for All program, an expanded specialty pharmacy network, and the relaunch of Triesence into what it calls its most significant market opportunity. Harrow also signed a deal to acquire Melt Pharmaceuticals, adding a sublingual midazolam/ketamine candidate for non-opioid, non-IV procedural sedation to its pipeline. Cash and cash equivalents stood at $74.3 million at quarter-end.
The step-change is less about a single product and more about a structural repositioning. Harrow is moving from a niche ophthalmic player with compounding and branded assets to a scaled specialty platform that aims to control access, distribution, and adherence in a PBM-dominated market, while planting a flag in peri-procedural care with Melt-300. That integration of payer strategy, specialty distribution, and adjacent-procedure innovation reflects how mid-cap specialty companies are competing: not by outspending category leaders, but by compressing friction between prescription and persistence.
For commercial leaders, Vevye’s preferred formulary status with several national payers, including the largest U.S. PBM by commercial lives, is the near-term catalyst. Dry eye remains crowded and rebate-driven, with cyclosporine and lifitegrast incumbents and newer entrants vying for share. Preferred placement can unlock prior authorization simplicity and lower out-of-pocket costs, but only if supply, coverage operations, and field pull-through align. Harrow’s expansion of its access programs and the addition of a third specialty pharmacy partner seek to close those gaps, promising broader insurance coverage, multilingual support, and streamlined fulfillment. If effective, this could increase initiation and persistence in a category where tolerability and time-to-benefit often erode adherence.
For Medical Affairs teams, the playbook now hinges on real-world evidence and HCP education to validate differentiation in outcomes and patient experience, particularly for Vevye in dry eye clinics and for Triesence across retina and surgical settings. The Melt-300 acquisition would extend Medical Affairs remit into office-based procedural sedation, an area aligned with systemwide efforts to reduce opioid exposure and simplify in-clinic workflows. Regulatory clarity, dose standardization, onset/offset data, and integration into outpatient pathways will determine whether sublingual sedation can displace entrenched IV protocols and whether payers reimburse it without onerous restrictions.
For payers and health systems, Harrow’s model signals more aggressive contracting and hub-enabled patient services that can lower access friction but raise the bar on evidence and economic value. Expect continued scrutiny of step therapy, prior authorization criteria, and net cost in dry eye, alongside careful assessment of site-of-care implications for procedural sedation. Competitors in ophthalmology should anticipate intensified access pressure and field activity through 2026 as formulary changes take effect.
The financials underscore both opportunity and constraint. Core gross margin reached 81%, operating cash flow turned positive for the nine months, and revenue growth is robust, yet loans payable of $242.9 million and quarterly interest expense of $6.0 million keep the execution bar high. The following year will test whether preferred access and a scaled specialty network can translate into durable market share gains and cash generation. At the same time, integration of Melt-300 introduces new regulatory and reimbursement gates. Can Harrow convert access wins into persistency-led growth fast enough to fund diversification, or will the cost of capital dictate a narrower focus in 2026?
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
