Clinical Endpoints and Outcomes From COMET-2 and -3 in Dry Eye Disease

In this segment, the expert panel reviews the COMET-1 and COMET-2 clinical trials, highlighting how these studies evaluated both signs and symptoms of dry eye disease to determine the therapeutic impact of Acoltremon. The faculty note that modern trial design has become more rigorous, minimizing the influence of “over-responders” and ensuring that outcomes reflect true drug activity. They emphasize that COMET trials demonstrated meaningful improvement in patient-reported symptoms—measured through tools such as the visual analog scale and the SANDE score—as well as objective measures of tear production and ocular surface health.

Panelists underscore the importance of rapid onset, noting that significant improvements in Schirmer scores were observed as early as two weeks. They also discuss the thoughtful design choice to avoid anesthetized Schirmer testing, which would suppress the very neural pathways Acoltremon targets. The faculty explain that conjunctival and corneal staining outcomes further validated efficacy and that safety results were strong, with very low discontinuation rates. Across the discussion, experts reiterate that symptom relief remains the ultimate clinical benchmark for sustained patient adherence.