Mati Therapeutics announced that it has completed a phase 2 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 multicenter, 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 = 0.032). In addition, 42% of patients using Nepafenac Evolute PPDS were pain-free throughout the trial period versus 0% for placebo (P < 0.001). Nepafenac Evolute also demonstrated a statistically significant difference for postoperative 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 2 trial are very exciting and we are looking forward to initiating our phase III trial in the near future,” Bob Butchofsky, CEO of Mati, said in a company news release. “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,” Eric Donnenfeld, MD, Ophthalmic Consultants of Long Island and Principle Investigator of the trial, said in the news release. “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.”