Alcon announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a candidate treatment for 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. In these studies, additional data derived from secondary endpoints demonstrated the rapid onset and sustained tear production associated with AR-15512 compared to vehicle, as early as Day 1 and persistent to Day 90.

Overall, AR-15512 was well tolerated and no serious ocular adverse events were reported. AR-15512 is an investigational drug product that has not been submitted to the U.S. Food and Drug Administration (FDA) for approval and is not currently commercially available. Alcon anticipates filing the NDA for AR-15512 with FDA in mid-2024.

Alcon's ophthalmic pharmaceutical portfolio currently includes Rocklatan, Rhopressa, Simbrinz, Eysuvis, and Inveltys.