Closely-held Mati Therapeutics reported encouraging results from a planned interim analysis of an ongoing Phase 2 clinical trial evaluating the safety and efficacy of nepafenac delivered in Mati’s Evolute sustained ocular drug delivery platform.
The trial is a masked evaluation of nepafenac versus placebo in 75 patients undergoing cataract surgery, with a primary endpoint to evaluate pain and a secondary endpoint of inflammation following surgery. The interim analysis was conducted with approximately 50% of patients enrolled in the study.
Pain scores favored nepafenac over placebo at day 1, day 3 and day 7 following surgery. At day 3, 71% of patients treated with nepafenac experienced no pain versus 12% in the placebo arm. Post-operative inflammation also favored the nepafenac Evolute arm. The treatment was generally well tolerated with no unexpected side effects reported.
In a statement, Bob Butchofsky, CEO, said the company looks forward to completing the trial in the near future. Mati also plans to submit updated study results and present available data at the upcoming American Academy of Ophthalmology meeting in October.
“Based on these positive results, we plan to initiate a larger Phase 3 registration study in 2019,” he added.
Dr. Eric Donnenfeld, of Ophthalmic Consultants of Long Island and principal investigator of the trial, said the ability to significantly reduce pain and inflammation, while reducing or eliminating topical medications from the most important procedure in ophthalmology is an important achievement.
In addition, “showing that this platform can deliver an NSAID in effective, sustained therapeutic doses is further proof that this platform can be beneficial in treating multiple diseases within ophthalmology,” he added.
