Harrow announced the US Food and Drug Administration (FDA) has cleared an investigational new drug 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, the company said in a press release. 

Harrow said expanding on-label Triesence usage to all cataract surgery patients will increase the number of patients benefiting from a preservative-free, sustained anti-inflammatory therapy at the time of surgery, reducing reliance on patient self-administration of complex, multi-week, at-home eyedrop regimens. 

The phase 3 trial is expected to enroll approximately 250 patients, who will be randomized in a 2:1 ratio to receive either Triesence or placebo. The primary efficacy endpoints are the absence of anterior chamber cells in the study eye at Day 14 and the absence of pain in the study eye at Day 8 following cataract surgery. Each patient will participate in the study for approximately 120 days, with the final visit occurring on Day 90, Harrow stated in the press release.