Shots:

• The P-III (COMET-2) & (COMET-3) clinical trials evaluate the safety & efficacy of AR-15512 vs vehicle control, randomized in a ratio 1:1, in patients (n=930) with signs & symptoms of dry eye disease
• The results from the 1EPs of the studies depicted that patients with at least a 10mm increase in unanesthetized Schirmer’s score achieved statistical significance at Day14, supporting the proposed MoA of AR-15512
• Moreover, the 2EPs showed rapid onset & sustained tear production associated with AR-15512 vs vehicle control. Based on these results, the company expects to file an NDA for the US FDA for AR-15512 (TRPM8 agonist) by mid-2024

Ref: Alcon | Image: Alcon

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