Harrow announces U.S. FDA cleared an IND application for trial of Triesence

Harrow (HROW) announced that the U.S. Food and Drug Administration has cleared an Investigational New Drug, IND, application to support a planned Phase 3 clinical trial evaluating Triesence 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.