Alcon’s ‘Positive’ Dry Eye Phase 3 Trials

Alcon has announced “positive topline results” from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512 for treating the signs and symptoms of dry eye disease (DED). “In both COMET-2 and COMET-3, which enrolled more than 930 dry eye subjects in total (randomized 1:1 to AR-15512 or vehicle control), the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score (a measure of tear production) achieved statistical significance at Day 14 [p<0.0001],” the company says. “These data are consistent with the proposed mechanism of action of AR-15512.”

Additionally, Alcon says AR-15512’s data from secondary endpoints demonstrated rapid onset and sustained tear production compared to vehicle, and overall the therapy was well tolerated and no serious ocular adverse events were reported.