Following positive topline results for AR-15512, a candidate treatment for the signs and symptoms of dry eye disease (DED), Alcon has announced it will submit a new drug application to the United States Food and Drug Administration in mid-2024.1

Two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) enrolled more than 930 dry eye subjects (randomised 1:1 to AR-15512 or vehicle control) and evaluated the efficacy and safety of AR-15512.

The primary endpoint of the proportion of subjects with at least a 10 mm increase in unanaesthetised Schirmer’s score (a measure of tear production) achieved statistical significance at day 14 [p<0.0001]; data consistent with the proposed mechanism of action of AR-15512.

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 one and persistent to day 90. Overall, it was well tolerated, and no serious ocular adverse events were reported.

“A key gap in dry eye medications is rapid speed of onset,” said Dr Edward Holland, 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.”

Reference
Alcon, Alcon announces positive topline results from phase 3 COMET trials of AR-15512, a novel topical drug candidate for dry eye (news release, 9 Jan 2024, available at: alcon.com/media-release/alcon-announces-positive-topline-resultsphase-3-comet-trials-ar-15512-novel-topical [accessed 11 Jan 2024].