Alcon Announces FDA Approval of TRYPTYR (Acoltremon Ophthalmic Solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease
- On May 31, 2025, Alcon announced that the U.S. FDA granted approval for TRYPTYR 0.003% to treat the signs and symptoms associated with dry eye disease.
- The approval followed two phase 3 trials, COMET-2 and COMET-3, involving over 930 patients with dry eye disease who were randomized 1:1 to TRYPTYR or vehicle.
- TRYPTYR acts as a TRPM8 receptor agonist by activating corneal sensory nerves, which quickly enhances the eye’s natural tear flow and targets the inadequate tear levels that contribute to dry eye disease.
- In the COMET-2 study, 42.6% of patients treated with TRYPTYR showed an improvement of 10 mm or more in tear secretion by the two-week mark, compared to 8.2% of those receiving the vehicle, with statistically significant differences observed as early as Day 1.
- The approval suggests a new rapid-acting treatment option addressing limitations of prior therapies, potentially improving patient outcomes for the many who report unsatisfactory management of dry eye disease.
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13 Articles
Alcon Announces FDA Approval of TRYPTRY Drops for Dry Eye
Photo courtesy of Alcon. Alcon has announced the U.S. Food and Drug Administration (FDA) has approved TRYPTYR® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED).3 TRYPTYR is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production.3 DED is a complex, multifactorial condition driven…
US FDA approves Alcon’s Tryptyr ophthalmic solution for Dry Eye Disease
Previously known as AR-15512, Tryptyr is a transient receptor potential melastatin 8 (TRPM8) receptor agonist that stimulates corneal sensory nerves to increase production of natural tears rapidly. It The post US FDA approves Alcon’s Tryptyr ophthalmic solution for Dry Eye Disease appeared first on Pharmaceutical Business review.
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