DURHAM, N.C.– 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.
“We are very pleased to have achieved statistically significant improvements on multiple FDA-recognized symptoms and signs in our COMET-1 Phase 2b clinical study. Of particular note, we are excited at the number of symptom endpoints which demonstrated statistical significance given the importance of this for patients suffering from dry eye disease. While we did not achieve statistical significance at our pre-determined primary endpoints at Day 28, as a reminder, this is a Phase 2b study where selecting primary endpoints are not required. Therefore, we believe we have a clear path toward approval,” stated Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “We expect to have an end of Phase 2 meeting with the U.S. Food and Drug Administration in the first quarter of 2022. In order to complete development of AR-15512, we expect to conduct two additional three-month Phase 3 efficacy studies and an additional safety study.”
AR-15512, formerly AVX-012, was acquired by Aerie in November 2019 in connection with the acquisition of Avizorex Pharma, S.L., a Spanish ophthalmic pharmaceutical company. AR-15512 has intellectual property protection for pharmaceutical composition and method of use through 2031.
