JCRS Publishes Phase 2 Nepafenac Clinical Trial With Evolute Sustained Drug Delivery System
Mati Therapeutics announced that a peer reviewed manuscript of a phase 2 clinical trial evaluating the safety and efficacy of Nepafenac delivered via Mati’s proprietary Evolute sustained ocular drug delivery platform has been published in the February Journal of Cataract and Refractive Surgery.
The trial is a multicenter, randomized, masked evaluation of Nepafenac vs. placebo in 56 patients undergoing cataract surgery. The primary endpoint was to evaluate pain and secondary endpoints including inflammation and visual acuity following surgery.
The Nepafenac Evolute patients had a significantly higher percentage of pain-free patients than the placebo group. This included 52% of patients in the Nepafenac group who were pain-free at all post-surgical visits compared to 0% in the placebo group (P=0.001). Postoperative inflammation, as determined by cell and flare scores, also favored the Nepafenac Evolute arm. Visual acuity was significantly better in the Nepafenac arm than the placebo arm. Device retention rates were 98.2% over the 2-week trial. All of the punctal plug delivery systems were placed prior to cataract surgery. The treatment was generally well tolerated with no unexpected side effects reported.
“The publication of these results is an important milestone for the company and highlights our commitment to bring sustained drug delivery technology forward to benefit patients with a number of different ocular diseases and conditions. In addition to focusing on managing postoperative pain and inflammation, we are also developing platforms for delivery of glaucoma, dry eye, and allergy medications and solutions,” Bob Butchofsky, CEO of Mati, said in a company news release.
“The results from the Nepafenac Evolute trial exceeded our expectations and were better than our prior experience with Nepafenac delivered as an eye drop. There is tremendous potential for the Mati Evolute sustained drug delivery platform,” said Eric Donnenfeld, MD, Ophthalmic Consultants of Long Island and lead author of the publication. “The ability to significantly reduce pain and inflammation while reducing or eliminating topical medications from one of the most critical procedures in ophthalmology is an important achievement. Additionally, showing that this platform can deliver an NSAID in effective, sustained therapeutic doses is further proof that the Evolute platform can be beneficial in treating multiple diseases where consistent dosing and delivery are important for eye health and patient comfort.”