Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512 for Dry Eye Disease

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 [P < 0.0001]. 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,” David Endicott, CEO of Alcon, said in a company news release. “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.”

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.

“A key gap in dry eye medications is rapid speed of onset,” said Edward Holland, MD, Professor of Ophthalmology at the University of Cincinnati, a key advisor on COMET-2 and -3 and Senior Scientific Advisor at Alcon. “AR-15512 demonstrated this important achievement in both pivotal efficacy and safety studies and it represents a first-in-class candidate for chronic dry eye.”

Alcon anticipates filing the NDA for AR-15512 with FDA in mid-2024.