Dosing of AR-15512 for dry eye begins in next step of COMET program
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The first subject has been dosed in the phase 3 registrational COMET-3 study investigating AR-15512 for the treatment of dry eye disease, according to a press release from Aerie Pharmaceuticals.
The randomized, double-masked, vehicle-controlled multicenter clinical study will enroll approximately 460 participants with dry eye disease who will be randomly assigned to receive either AR-15512 0.003% or AR-15512 vehicle as a drop twice daily in each eye for 3 months. Tear production, measured by unanesthetized Schirmer’s test, is the primary efficacy assessment, with a secondary measure of dry eye symptoms based on the SANDE questionnaire. In addition, efficacy and safety will be assessed throughout the study.
“The COMET program has strong momentum, driven by the effective collaboration with the COMET-2 and COMET-3 investigators,” Michelle Senchyna, PhD, head of clinical development and medical affairs at Aerie, said in the 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.”
Aerie plans to initiate the COMET-4 safety study later this year and file a new drug application with the FDA for AR-15512 in 2024, according to the release.
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