Aerie Pharmaceuticals doses first participant in the COMET-3 study of candidate for treatment of dry eye

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According to the company, AR-15512 is a differentiated, novel, first-in-class product candidate for the treatment of the signs and symptoms of dry eye disease.

Aerie Pharmaceuticals Inc. this week 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).

The company noted in a news release that COMET-3 is the second of three trials in the Phase 3 registrational program for AR-15512. Aerie said in the release that it 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.

According to the company, COMET-3 is a randomly assigned, double-masked, vehicle-controlled, multi-center 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 and is identical in design to the COMET-2 study, which began enrolling in May 2022.

Study participants will be randomly assigned 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.

Michelle Senchyna, PhD, head of Clinical Development and Medical Affairs at Aerie, noted in the news release that the company was pleased at the prospects of enrolling the first participant in the COMET-3 study.

“The COMET program has strong momentum, driven by the effective collaboration with the COMET-2 and COMET-3 investigators,” she said in the news release. “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 top-line results for both studies in the second half of 2023.”

David Wirta, MD, 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 detailed the need for treatment options. 

“We see a large, unmet need for dry eye disease treatments that can provide rapid relief of DED signs and symptoms,” he said in eh news release. 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.

AR-15512 Phase 3 Registrational Program
According to the company y, 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.