AUSTIN, Texas--(BUSINESS WIRE)--Mati Therapeutics Inc. (“Mati”) announced that it has completed a planned interim analysis of an ongoing Phase II clinical trial evaluating the safety and efficacy of nepafenac delivered in Mati’s proprietary Evolute® sustained ocular drug delivery platform. The trial is a multi-center, 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. Post-operative 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 II trial are very encouraging, and we are looking forward to completing the trial in the near future,” said Bob Butchofsky, CEO of Mati. “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 III registration study in 2019.”
“We are very encouraged by these topline results for a very promising drug delivery platform,” said Eric Donnenfeld, M.D., 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.”
About Mati Therapeutics Inc.
Mati is developing the Evolute® sustained ocular drug delivery platform, which Mati believes has the potential to treat a range of ocular indications. The platform utilizes a device called a punctal plug, which is easily inserted into a patient’s punctum. The device has already been approved to treat dry eye syndrome, but Mati is the first to conduct clinical trials in the U.S. using punctal plugs as an anchoring device for a drug delivery platform. A drug-eluting core is inserted into Mati’s proprietary punctal plug, which allows medication to be continuously released into the tear film of the eye over a period of time. Mati believes the Evolute® platform has the potential to become a more reliable alternative to several eye drop therapies, which can be ineffective because many patients are unwilling or unable to adhere to self-administered eye-drop regimens.
Mati has completed multiple Phase II clinical trials using the Evolute® platform, including multiple trials in glaucoma, ocular hypertension, and allergy patients. Mati’s proprietary punctal plug design has demonstrated excellent lower punctum retention rates of 92% and 96% over a 12-week follow-up period in two separate multi-center U.S. clinical trials.
To learn more about Mati Therapeutics, visit www.MatiTherapeutics.com.