Aerie Pharmaceuticals Announces First Participant Dosed in the Phase 3 COMET-2 Study of AR-15512 for the Treatment of Dry Eye Disease
Aerie Pharmaceuticals announced that the first participant has been dosed in the phase 3 registrational “COMET-2” study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye disease (DED). COMET-2 is the first of three trials in the phase 3 registrational program for AR-15512. Aerie plans to initiate the other two trials in the second half of 2022 in support of a potential new drug application (NDA) filing in 2024.
COMET-2 is a randomized, double-masked, vehicle-controlled, multicenter clinical study to evaluate the efficacy and safety of AR-15512, a TRPM8 agonist, in patients with DED. The study is expected to enroll approximately 460 participants at 20 U.S. sites. Study participants will receive AR-15512 (0.003%) or AR-15512 vehicle as a drop dosed twice daily in each eye for 3 months. The primary efficacy assessment is tear production, as measured by the unanesthetized Schirmer test (sign), and the key secondary measure is dry eye symptoms based on the Symptom Assessment iN Dry Eye (SANDE) questionnaire. Participants will be evaluated on multiple efficacy and safety assessments at multiple timepoints throughout the study. Topline results from the COMET-2 study are expected in the second half of 2023.
“Aerie is excited to mark the beginning of our registrational phase 3 program for AR-15512 with the enrollment of the first participant in the COMET-2 study,” said Michelle Senchyna, PhD, Head of Clinical Development and Medical Affairs at Aerie. “This study builds on the results of the COMET-1 study, which showed statistically significant, dose-dependent improvements on multiple validated sign, symptom, and quality of life endpoints across multiple timepoints.”
“There is a significant unmet need for an effective treatment that can provide a rapid and robust onset of efficacy, and meaningful relief of dry eye symptoms. AR-15512 has the potential to be the new standard of care for patients suffering from dry eye disease," Dr. Senchyna said.
About the AR-15512 Phase 3 Registrational Program
The AR-15512 phase 3 registrational program is comprised of three studies, the COMET-2 and COMET-3 efficacy studies and the COMET-4 safety study, that will evaluate AR-15512 (0.003%) compared to AR-15512 vehicle in participants with DED. COMET-2, which is currently enrolling, and COMET-3, which is expected to begin in the third quarter of 2022, are identical studies with topline results expected in the second half of 2023. COMET-4, which is expected to begin in the fourth quarter of 2022, is a 12-month safety study. Aerie will incorporate interim 6-month data from COMET-4 into the NDA filing for AR-15512, which is expected to be submitted in 2024.