Aerie Pharmaceuticals Announces First Patient Dosed in the COMET-3 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-3” study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye disease (DED). COMET-3 is the second of three trials in the phase 3 registrational program for AR-15512. Aerie plans to initiate the last of the trials, the COMET-4 safety study, in the fourth quarter of 2022. Aerie intends to complete the AR-15512 registrational program in 2023 and, assuming clinical success, plans to file a new drug application (NDA) with the FDA in 2024.
COMET-3 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 US sites and is identical in design to the COMET-2 study, which began enrolling in May 2022. Study participants will be randomized in a 1:1 ratio to receive either 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’s 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.
“Aerie is delighted to have enrolled the first participant in the COMET-3 study,” Michelle Senchyna, PhD, Head of Clinical Development and Medical Affairs at Aerie, said in a company news release. “The COMET program has strong momentum, driven by the effective collaboration with the COMET-2 and COMET-3 investigators. The clinical data from the COMET-1 study showed statistically significant, dose-dependent improvements on multiple validated sign, symptom, and quality of life endpoints across multiple timepoints that informed our selection of the proper dose, primary and secondary endpoints and inclusion/exclusion criteria for the phase 3 program. With enrollment now underway in both registrational efficacy studies, we remain on track to announce topline results for both studies in the second half of 2023.”
Dr. David Wirta, an oculoplastic surgeon and Medical Director at the Eye Research Foundation in Newport Beach, California and an investigator in the COMET-1 and COMET-3 studies observed, “We see a large, unmet need for dry eye disease treatments that can provide rapid relief of DED signs and symptoms. We are pleased to participate in the COMET-3 study and, based on the encouraging results of the COMET-1 study, believe that AR-15512 could represent a novel and attractive treatment option for patients with dry eye disease.”
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. Enrollment is underway in COMET-2 and COMET-3, which are identical studies, and topline results are 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.
About AR-15512
AR-15512 is a first-in-class TRPM8 agonist which acts as a cold thermoreceptor modulator to stimulate the cold sensing receptors found on the nerve endings that innervate the cornea and eyelids. By stimulating these receptors, AR-15512 leads to natural tear production and a cooling sensation across the surface of the eye that may result in a reduction in dry eye symptoms.