AUSTIN, Texas--(BUSINESS WIRE)--Mati Therapeutics Inc. (“Mati”) announced that it has completed a Phase II clinical trial evaluating the safety and efficacy of nepafenac delivered in Mati’s proprietary Evolute® sustained ocular punctal plug drug delivery platform. The trial was a multi-center, randomized, masked evaluation of Nepafenac Evolute® vs. placebo in 56 patients undergoing cataract surgery. The primary endpoint was pain with a secondary endpoint of inflammation following surgery.
Nepafenac Evolute® demonstrated a statistically significant difference compared to placebo for pain scores at Day 3 following surgery. At Day 3, 70% of patients treated with Nepafenac Evolute® experienced No Pain versus 38% in the placebo arm (p value = 0.032). In addition, 42% of patients using Nepafenac Evolute® PPDS were pain-free throughout the trial period versus 0% for placebo (p value < 0.001). Nepafenac Evolute® also demonstrated a statistically significant difference for post-operative inflammation, as determined by cell and flare scores, for subjects with None-to-Mild anterior chamber cells at Day 3. The treatment was very well tolerated with no serious or unexpected adverse events reported. In addition, Mati’s punctal plug delivery platform demonstrated a 98% retention rate in 48 subjects over 215 patients visits.
The effective control of pain and inflammation with Nepafenac Evolute® following cataract surgery resulted in improved clinical outcomes as evidenced by best corrected and uncorrected visual acuity scores. Treatment with Nepafenac Evolute® resulted in statistically significant improvements over placebo at Day 14. The percentage of subjects with 20/20 or better best corrected visual acuity was 65% for subjects treated with Nepafenac Evolute® versus 29% for those treated with placebo (p=0.021). The percentage of subjects with an uncorrected visual acuity of 20/25 or better was 53% for Nepafenac Evolute® versus 14% for placebo (p=0.001).
“The final results of this Phase II trial are very exciting and we are looking forward to initiating our phase III trial in the near future,” said Bob Butchofsky, CEO of Mati. “We believe these exceptional results in pain and inflammation control with an NSAID Evolute can be of great benefit to patients and physicians alike.”
“We are very pleased and encouraged by these 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 a very effective, sustained therapeutic dose, which led to a clinical and statistically significant number of patients seeing 20/20 or better verses placebo, 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.