Alcon reports ‘positive’ topline results from Phase 3 COMET trials of AR-15512

Alcon announced positive topline results from the two pivotal Phase 3 clinical trials evaluating the efficacy and safety of AR-15512, a candidate treatment for the signs and symptoms of dry eye disease. In both COMET-2 and COMET-3, which enrolled more than 930 dry eye subjects in total, the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score achieved statistical significance at Day 14. These data are consistent with the proposed mechanism of action of AR-15512. “We are excited by AR-15512 as it has the potential to address the limitations of current dry eye prescription options and provide Eye Care Professionals (ECPs) and dry eye sufferers with a new and effective approach to the management of dry eye, a chronic and undertreated disease,” said David Endicott, CEO of Alcon. “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.”