FDA Clears Harrow's Phase 3 Trial for TRIESENCE in Cataract Surgery Patients
Key Insights
The U.S. FDA has cleared Harrow Inc. (search)'s Investigational New Drug application to support a Phase 3 clinical trial of TRIESENCE for treating ocular inflammation (search) and pain following cataract (search) surgery.
The randomized, placebo-controlled, double-masked, multicenter study is expected to begin in the first quarter of 2026, targeting the more than 4 million annual cataract (search) surgeries performed in the U.S.
Market research shows strong surgeon interest in "dropless" approaches, with nearly nine out of ten cataract (search) surgeons expressing interest and about half reporting high interest.
Harrow Inc. (search) (HROW) announced that the U.S. FDA has cleared its Investigational New Drug (IND) application to support a Phase 3 clinical trial of TRIESENCE (preservative-free triamcinolone acetonide injectable suspension, 40 mg/mL). The study will evaluate TRIESENCE for the treatment of ocular inflammation (search) and pain following cataract (search) surgery.
Phase 3 Trial Design and Timeline
The Phase 3 trial is designed as a randomized, placebo-controlled, double-masked, multicenter study and is expected to begin in the first quarter of 2026. This development comes as cataract (search) surgery represents one of the most common procedures in the U.S., with more than 4 million performed annually. As volumes rise, there is growing demand for therapies that simplify care, reduce reliance on post-operative eye drops, and improve patient outcomes.
Market Demand for Dropless Solutions
Market research cited by Harrow shows strong interest among surgeons in "dropless" approaches, with nearly nine out of ten cataract (search) surgeons expressing interest and about half reporting high interest. Patients also indicated preference for eliminating post-surgery drops, highlighting alignment between physician and patient needs.
Current TRIESENCE Applications and Potential Benefits
TRIESENCE is already FDA-approved for intraocular use and widely utilized by ophthalmologists to treat ocular inflammation (search). Expanding its label to include cataract (search) surgery patients could reduce challenges with eye drop adherence, particularly among older individuals facing dexterity or cognitive limitations. Harrow noted that broader use of TRIESENCE would give physicians greater control over post-operative inflammation management while easing the burden on patients.
Market Response
Despite the regulatory milestone, Harrow's stock fell significantly following the announcement. HROW has traded between $20.85 and $54.85 over the past year. The stock closed Monday's trading at $53.59, down 1.09%. Shares fell 12.97% to $46.64 in premarket trading Tuesday, and continued declining to $41.94, down 21.78 percent or $11.60 during Tuesday morning trading.