COMET-3 is the second of 3 studies in the AR-15512 Registrational Phase 3 Program, which is slated for completion by 2023.
Aerie Pharmaceuticals announced Monday that the first patient has been dosed in the phase 3 registrational “COMET-3” study evaluating AR-15513 ophthalmic solution for the treatment of dry eye disease (DED).
The COMET-3 study is a randomized, double-masked, vehicle-controlled, multi-center clinical study evaluating the safety and efficacy of AR-15512—which is a TRPM8 agonist—in patients diagnosed with DED, according to a company news release.
The clinical study anticipates enrolling an estimated 460 patients at 20 sites across the US. It is designed to be identical to the COMET-2 study that began enrolling earlier this year, in May 2022. COMET-3 study patients will be randomized in a 1:1 ratio to be administered either AR-15512 (0.003%) or AR-15512 vehicle as a twice-daily dosed drop in each eye for 3 months, the release stated.
Additional trial details include: primary efficacy assessment for the trial is tear production measured by the unanesthetized Schirmer’s Test (sign) ad well as a key secondary measure of dry eye symptoms based on the Symptom Assessment iN Dry Eye (SANDE) questionnaire.
All trial participants will be evaluated on multiple efficacy and safety assessments at multiple timepoints throughout the study, according to release.
As the second of three trials in AR-15512’s phase 3 registrational program, COMET-3 will be followed by the commencement of COMET-4 safety study in the 4th quarter of 2022, according to the release. COMET-4 will be the last of the trials.
According to Michelle Senchyna, PhD, head of Aerie’s clinical development and medical affairs, COMET program has strong momentum that is driven by the effective collaboration with the COMET-2 and COMET-3 trials’ 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,” Senchyna stated in the release. “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.”
The AR-15512 registrational program is slated for completion in 2023, providing clinical success. Aerie plans to file a New Drug Application (NDA) with the FDA in 2024, the release reported.