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JCRS Publication of Phase II Nepafenac Clinical Trial With Evolute® Sustained Drug Delivery System Demonstrates Significant Post-Op Pain Reduction in Cataract Surgery Patients
Positive Results for Sustained Delivery Platform in Post-op Pain and Inflammation
AUSTIN, Texas--(BUSINESS WIRE)--Mati Therapeutics Inc. (“Mati”) announced that a peer reviewed manuscript of a Phase II 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 multi-center, 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,” said Bob Butchofsky, CEO of Mati.
“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, M.D., 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.”
Mati’s current focus is on the nepafenac punctal plug delivery system (“N-PPDS”) for the relief of pain and inflammation following cataract surgery. The program is currently in a Phase III multi-center clinical trial in the United States.
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.
Contacts: Mati Therapeutics Inc. Bob Butchofsky, CEO, 512-329-6360 bbutchofsky@matitherapeutics.com