Alcon Inc. (ALC)’s TRYPTYR Wins FDA Nod for Dry Eye Disease

Alcon Inc. (NYSE:ALC) has announced that the U.S. Food and Drug Administration (FDA) has approved TRYPTYR (acoltremon ophthalmic solution) 0.003% for the treatment of signs and symptoms of Dry Eye Disease (DED), marking a major milestone for Alcon Inc. (NYSE:ALC) and patients alike.

TRYPTYR is the first-in-class TRPM8 receptor agonist eye drop, designed to rapidly stimulate natural tear production by targeting corneal sensory nerves, a novel approach for DED management.

A healthcare professional wearing a health communications device discussing patient data with a colleague.

In pivotal Phase 3 trials (COMET-2 and COMET-3), TRYPTYR demonstrated a significant increase in natural tear production as early as Day 1, with up to four times more patients achieving at least a 10mm increase in tear production at Day 14 compared to placebo (42.6% vs 8.2% in COMET-2; 53.2% vs 14.4% in COMET-3). These results were consistent through Day 90, highlighting its rapid and sustained efficacy.

With nearly 38 million Americans affected by DED but less than 10% receiving prescription treatment, TRYPTYR addresses a critical unmet need, especially given the dissatisfaction and slow onset associated with existing therapies. Alcon Inc. (NYSE:ALC) expects to launch TRYPTYR in the U.S. in the third quarter of 2025.

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Disclosure: None.