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Harrow to Initiate Phase 3 Clinical Trial Seeking to Expand TRIESENCE® Label to Include Ocular Inflammation and Pain Following Cataract Surgery Indication
NASHVILLE, Tenn., March 03, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America,
About this update from Harrow, Inc.
[{"type":"text","content":"NASHVILLE, Tenn., March 03, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to support a planned Phase 3 clinical trial evaluating TRIESENCE (preservative-free triamcinolone acetonide injectable suspension) 40 mg/mL for the treatment of ocular inflammation and pain following cataract surgery. The planned Phase 3 study is a randomized, placebo-controlled, double-masked, multicenter clinical trial designed to evaluate the safety and efficacy of TRIESENCE in patients undergoing cataract surgery. Harrow expects to initiate the study in the first quarter of 2026. Cataract surgery is among the most commonly performed surgical procedures in the United States, with more than 4 million procedures completed annually and volumes expected to grow as the population agesi. As procedure volumes continue to rise, solutions that improve efficiency, enhance patient experience, and reduce post-operative burden are becoming increasingly important to both surgeons and healthcare systems. Recent third-party market research further underscores this shift in surgical practice patterns. In a Market Scope survey of U.S. cataract surgeons, nearly nine out of ten respondents indicated interest in a dropless surgical approach, with roughly half characterizing themselves as highly interestedii. The same survey also reported meaningful patient preference for eliminating post-operative drops. Together, these findings underscore growing alignment between surgeon and patient demand for simplified perioperative care. TRIESENCE is an FDA-approved triamcinolone preservative-free formulation for intraocular use and is widely utilized by ophthalmologists for the treatment of ocular inflammation. Adoption has been particularly strong among surgeons treating cataract patients, for whom post-operative eye drop adherence can be challenging due to dexterity hurdles, cognitive limitations, compliance concerns, limited caregiver support, or other age-related comorbidities. By expanding on-label TRIESENCE usage to all cataract surgery patients, Harrow will increase the number of patients benefiting from a preservative-free, sustained anti-inflammatory therapy at the time of s...