Aerie Pharmaceuticals, Inc. AERI has dosed the first patient in the Phase 3 COMET-2 study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye disease (DED).
This study is the first of three trials in the Phase 3 registrational program for AR-15512.
Aerie Pharmaceuticals is expected to enroll approximately 460 patients at 20 sites in United States.
The enrolled subjects will be evaluated on multiple efficacy and safety assessments at multiple timepoints throughout the study.
Michelle Senchyna, Ph.D., Head of Clinical Development and Medical Affairs, said, “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, 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."
Topline results from the COMET-2 study are expected in the second half of 2023.
Aerie Pharmaceuticals lost 8.35% Tuesday, closing at $5.93.
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