The U.S. Food and Drug Administration granted clearance on March 4, 2026 for an Investigational New Drug application that will allow Harrow, Inc. to conduct a Phase 3 clinical trial of its preservative‑free triamcinolone acetonide injectable suspension, TRIESENCE, in patients undergoing cataract surgery. The trial will enroll approximately 250 patients across multiple U.S. sites, randomizing participants 2:1 to TRIESENCE versus placebo. It is randomized, placebo‑controlled, double‑masked, and will evaluate the safety and efficacy of a 40 mg/mL formulation for the treatment of ocular inflammation and pain after cataract removal. Primary endpoints include the absence of anterior chamber cells at Day 14 and the absence of pain at Day 8 post‑surgery.
This clearance marks a key milestone in Harrow’s strategy to broaden TRIESENCE’s indication beyond its current uses for ocular inflammation. By targeting the post‑cataract surgery population, the company could tap into more than 4 million cataract procedures performed annually in the United States, potentially creating a new revenue stream that complements its existing ophthalmic portfolio.
Harrow’s recent financial results underscore the company’s growth trajectory. In Q4 2025, revenue reached $89.1 million, up 33% year‑over‑year, while full‑year 2025 revenue totaled $272.3 million, a 36% increase from 2024. GAAP net income for Q4 was $6.6 million, and the full year reported a net loss of $5.1 million. Adjusted EBITDA was $24.2 million in Q4 and $61.9 million for the full year. Management guided 2026 revenue to $350 million–$365 million and adjusted EBITDA to $80 million–$100 million, reflecting confidence in continued demand and operational leverage.
"Last year was a defining year for Harrow, with revenue up 36% for the year and a record fourth quarter that reflected both accelerating demand and improving operating leverage," said CEO Mark L. Baum in the Q4 2025 earnings release. Chief scientific officer Amir Shojaei added, "The formulation and composition haven't changed at all. TRIESENCE remains the only preservative‑free corticosteroid approved for intraocular use and for visualization during surgery."
Analysts have maintained a strong‑buy consensus on Harrow, with 86% recommending a strong buy and 14% a buy. While the stock has experienced recent pressure, the company’s 1‑year total shareholder return stands at 49.41%, reflecting the market’s recognition of its growth potential.
The FDA clearance positions Harrow to potentially capture a large and growing market, supports its broader growth strategy, and may influence future guidance on revenue and profitability as the Phase 3 trial progresses.
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