Mati Therapeutics announced that it has completed a planned interim analysis of an ongoing phase 2 clinical trial evaluating the safety and efficacy of nepafenac delivered in Mati’s proprietary Evolute sustained ocular drug delivery platform. The trial is a multicenter, randomized, masked evaluation of nepafenac vs. placebo in 75 patients undergoing cataract surgery. The primary endpoint is to evaluate pain and the secondary endpoint is to evaluate inflammation following surgery. This planned 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. Postoperative inflammation, as determined by cell and flare scores, also favored the Nepafenac Evolute arm. The treatment was generally well tolerated with no unexpected side effects reported.
“The interim results of this ongoing phase 2 trial are very encouraging, and we are looking forward to completing the trial in the near future,” Bob Butchofsky, CEO of Mati, said in a company news release. “We also plan on submitting updated study results and presenting the available data at the upcoming American Academy of Ophthalmology meeting held in Chicago in October. Based on these positive results we plan to initiate a larger phase 3 registration study in 2019.”
“We are very encouraged by these topline results for a very promising drug delivery platform,” said Eric Donnenfeld, MD, Ophthalmic Consultants of Long Island and Principle Investigator of the trial. “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. Additionally, 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.”