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# Alcon Dry Eye Drug Tryptyr Approved
- URL: https://www.fdaweb.com/alcon-dry-eye-drug-tryptyr-approved/
- Published: 2025-05-29T12:00:00.000Z
- Updated: 2026-09-14T15:12:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159267

FDA has approved an Alcon NDA for Tryptyr (acoltremon ophthalmic solution) 0.003% for treating the signs and symptoms of dry eye disease (DED). Tryptyr is described as a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production.

Approval is based on data from two Phase 3 clinical trials evaluating more than 930 patients with a history of DED. “In COMET-2 and COMET-3, up to four times more Tryptyr patients experienced at least a 10mm increase in natural tear production at Day 14, compared to vehicle, 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 (both p<0.0001),” the company says.