Therapy Areas: AIDS & HIV
Mati Therapeutics Phase II Nepafenac Evolute Clinical Trial Results Show Significant Post-Operative Pain Reduction in Cataract Surgery Patients
10 May 2019 - - US-based drug delivery platform developer Mati Therapeutics Inc. 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 company said.

The trial was a multi-center, randomised, 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 Evoluteresulted 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).

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 utilises 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 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 US clinical trials.


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