Aerie Shares Gain Following Patient Dosing In Late-Stage Dry Eye Disease Study

Aerie Pharmaceuticals AERI has initiated patient dosing 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 study is a multi-center clinical study to evaluate the efficacy and safety of AR-15512 in patients with DED. The study is expected to enroll approximately 460 participants at 20 U.S. sites.

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.

Michelle Senchyna, Head of Clinical Development and Medical Affairs, said, "Aerie is delighted to have enrolled 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. 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.”

Further, Aerie is planning to initiate the last of the trials, the COMET-4 safety study, in the fourth quarter of 2022. The topline results from COMET-3 and COMET-4 studies are expected in the second half of 2023.

Finally, the company intends to complete the AR-15512 registrational program in 2023 and plans to file a New Drug Application (NDA) with the regulatory agency in 2024.

Price Action : Aerie shares trading around 5 percent higher at $6.69 on Monday during after-hours session.