AR-15512 shows promise in treating dry eye disease in Phase 3 studies

AR-15512, a selective TRPM8 agonist, has shown strong efficacy in increasing tear production and improving symptoms in patients with dry eye disease (DED) in two Phase 3 clinical trials, according to a poster presented at the 2024 American Academy of Optometry Annual Meeting

In these studies, AR-15512 was shown to significantly improve tear production compared to a vehicle treatment. The primary endpoint, defined as a ≥10 mm increase in unanesthetized Schirmer test score by day 14, was met in both studies. In the first study, 42.6% of patients receiving AR-15512 saw this improvement, compared to only 8.2% with the vehicle (P < 0.0001). In the second study, 53.2% of those on AR-15512 had the same improvement versus 14.4% with the vehicle (P < 0.0001). Rapid onset of tear production was observed as early as day 1, and sustained benefits were maintained throughout the 90-day treatment period.

Secondary endpoints also showed strong results, with treatment differences favoring AR-15512 ranging from 26.7% to 43.8%. The least squares mean change from baseline in Schirmer test scores was significantly higher for AR-15512 (ranging from 6.2 to 9.2 mm) compared to the vehicle (ranging from 2.3 to 3.7 mm).

Reference
Whitley, et al. Tear Production Associated with a Novel TRPM8 Agonist (AR-15512): Results from Phase 3 Pivotal Clinical Studies (COMET-2 and COMET-3). 2024 American Academy of Optometry Annual Meeting; November 6-9, 2024; Indianapolis, IN.