Benzinga | Sep 15, 2021 04:03PM EDT

Aerie Pharmaceuticals Announces Novel Dry Eye Product Candidate AR-15512 Ophthalmic Solution Achieved Statistical Significance Over Multiple Symptoms And Signs In Successful Phase 2b Clinical Study For The Treatment Of Dry Eye Disease

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases, today reported positive topline results of its Phase 2b clinical study, named COMET-1, for AR-15512 (TRPM8 Agonist) ("AR-15512") ophthalmic solution for the treatment of patients with dry eye disease. Management will host a conference call and provide accompanying slides to discuss these results at 5:00 p.m. ET today.

The randomized, double-masked, vehicle-controlled Phase 2b clinical study was conducted at 15 sites throughout the United States and evaluated the efficacy and safety of AR-15512 in patients with dry eye disease. A total of 369 patients were randomized across three arms, AR-15512 (0.0014%), AR-15512 (0.003%) or AR-15512 vehicle, in each case dosed twice daily over 84 days. Patients were evaluated at Days 1, 14, 28 and 84.

AR-15512 Phase 2b Highlights

* The COMET-1 clinical study showed greatest efficacy in the higher concentration 0.003% BID which will be advanced to Phase 3 studies.

* The COMET-1 clinical study achieved statistical significance for multiple pre-specified symptom endpoints: Ocular discomfort at Day 84 (p=0.028), SANDE (Symptom Assessment iN Dry Eye) at Days 14, 28 and 84 (p-value between 0.025 and 0.0005) and eye dryness at Day 84 (p=0.03)

* The COMET-1 clinical study achieved statistical significance for multiple pre-specified sign endpoints: Efficacy was observed after the first dose Tear production at both time points measured (Day 1 and Day 14) based on unanesthetized Schirmer's score (p<0.0001), conjunctival redness at Day 84 (p=0.022) and ocular surface staining at Day 14 and Day 84 (p=0.012 and p=0.037, respectively)

* The COMET-1 clinical study showed statistically significant improvement in both symptoms and signs as early as Day 14 and continuous improvement through Day 84.

* Both formulations of AR-15512 were safe and well-tolerated. Ninety five percent of adverse events were mild with less than 3 percent of subjects discontinued due to adverse events.