Alcon has announced positive topline results from 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. 

The trials enrolled more than 930 dry eye subjects (randomised 1:1 to AR-15512 or vehicle control). The primary endpoint was the proportion of subjects with at least a 10mm increase in un-anesthetised Schirmer’s score who achieved statistical significance at day 14, consistent with the proposed mechanism of action for 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 1 and persistent to day 90. Overall, the results showed AR-15512 was well tolerated and no serious ocular adverse events were reported. 

“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 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.  

Alcon expects to file an Investigational New Drug (NDA) registration for AR-15512 with the US Food and Drug Administration in mid-2024.