Good News For Dry Eye Disease Patients: Eye Care Focused Alcon's Treatment Shows Encouraging Benefit In Late-Stage Trials

Alcon ALC released topline results from the two Phase 3 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.

Also Read: Why Medical Device Company Alcon Shares Are Sliding Today.

DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., and about 18 million are diagnosed, and less than 10% of those diagnosed are treated with a prescription product.

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.

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

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

Price Action: ALC shares are up 4.55% at $80.16 during the premarket session on the last check Wednesday.

Image by Aline Berry from Pixabay