5 September 2018 - - US-based drug delivery platform developer Mati Therapeutics Inc. 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 company said.

The trial is a multi-center, randomised, 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.

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 US 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 has completed multiple Phase II clinical trials using the Evolute platform, including multiple trials in glaucoma, ocular hypertension, and allergy patients.

The company'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-centre US clinical trials.