Mati Therapeutics has completed a phase II clinical trial to evaluate the safety and efficacy of nepafenac delivered in Mati’s proprietary Evolute sustained ocular punctal plug drug delivery platform.
Mati Therapeutics has carried out the trial as a multi-center, randomized, masked evaluation of Nepafenac Evolute vs. placebo in 56 patients undergoing cataract surgery.
In the clinical trial, the company has set the pain as a primary endpoint while inflammation following surgery as a secondary endpoint.
Mati said that its Nepafenac Evolute has shown a statistically significant difference compared to placebo for pain scores at Day 3 following surgery.
The trial showed that 70% of patients treated with Nepafenac Evolute have experienced no pain on the third day versus 38% in the placebo arm and 42% of patients using Nepafenac Evolute PPDS were pain-free throughout the trial period, while it was 0% for placebo.
Mati said that its Nepafenac Evolute has also showed a significant difference in post-operative inflammation for subjects with none-to-mild anterior chamber cells at day 3 and the treatment was tolerated with no serious or unexpected adverse events reported.
Mati CEO Bob Butchofsky said: “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. We believe these exceptional results in pain and inflammation control with an NSAID Evolute can be of great benefit to patients and physicians alike.”
The company said that the control of pain and inflammation using Nepafenac Evolute after the cataract surgery has resulted in improved clinical outcomes as evidenced by best corrected and uncorrected visual acuity scores.
In addition, 65% of the subjects treated with Nepafenac Evolute have shown 20/20 or better corrected visual acuity while those treated with placebo shown 29% and 53% of subjects treated with Nepafenac Evolute shown 20/25 or better while 14% patients with placebo.
Clinical trial principle investigator Eric Donnenfeld said: “We are very pleased and encouraged by these results for a very promising drug delivery platform. 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.”