The first participant has been dosed in the phase 3 registrational COMET-2 study of AR-15512 ophthalmic solution for the treatment of dry eye disease signs and symptoms, according to a press release from Aerie Pharmaceuticals.
Approximately 460 participants at 20 US sites will receive AR-15512 0.003% or AR-15512 vehicle twice daily in each eye for 3 months in the randomized, double-masked, vehicle-controlled multicenter clinical study. Tear production measured by Schirmer test is the primary efficacy assessment, with the key secondary measure consisting of dry eye symptoms based on the SANDE questionnaire.
Topline study results are expected in the second half of 2023.
“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,” Michelle Senchyna, PhD, head of clinical development and medical affairs at Aerie, said in the release.
Two other trials in the phase 3 registrational program are expected to begin later this year to support a potential new drug application filing in 2024.