Aerie Pharmaceuticals Announces First Participant Dosed in the Phase 3 Registrational COMET-2 Study of AR-15512 for the Treatment of Dry Eye Disease
AR-15512 is a differentiated, novel, first-in-class product candidate for the treatment of the signs and symptoms of Dry Eye Disease
COMET-2 is the first of three studies in the AR-15512 Phase 3 Program
COMET-2 is a randomized, 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. Study participants will receive AR-15512 (0.003%) or AR-15512 vehicle as a drop dosed twice daily in each eye for three 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
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.
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.
About Dry Eye Disease
Dry eye disease affects about 30 million people in the
The COMET-1 study evaluated two doses of AR-15512 compared to AR-15512 vehicle in 369 participants with DED. As reported in
AR-15512 is a development stage product candidate and is not approved by any regulatory agency.
Aerie is a pharmaceutical company focused on the discovery, development, and commercialization of first-in-class ophthalmic therapies for the treatment of patients with eye diseases and conditions including open-angle glaucoma, dry eye, diabetic macular edema (DME), and wet age-related macular degeneration (wet
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1. Market Scope 2021 Dry Eye Product Market Review