GENEVA — Alcon, a global leader in eye care, announced that the U.S. Food and Drug Administration (FDA) has approved TRYPTYR® (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of Dry Eye Disease (DED). The approval marks Alcon’s first FDA-approved prescription pharmaceutical since becoming an independent, publicly traded company.
TRYPTYR is a first-in-class TRPM8 receptor agonist designed to stimulate corneal nerves and rapidly promote natural tear production. It addresses a key cause of DED—tear deficiency—and is intended for patients who have struggled with slow-onset or ineffective treatments. According to Alcon, DED affects approximately 38 million people in the U.S., yet fewer than 10% of those diagnosed currently receive prescription therapies.
“This is a tremendous milestone for Alcon and a major advancement for patients,” said David Endicott, CEO of Alcon. “TRYPTYR offers a fast-acting and innovative treatment for millions suffering from dry eye and reflects our commitment to expanding pharmaceutical options in eye care.”
The FDA’s decision was based on data from two pivotal Phase 3 clinical trials, COMET-2 and COMET-3, which included over 930 patients with a history of DED. In both studies, TRYPTYR showed rapid and sustained improvement in tear production. By Day 14, up to four times more patients treated with TRYPTYR experienced at least a 10mm increase in tear production compared to those given a placebo. Improvements were seen as early as Day 1 and were sustained through Day 90.
“Many patients with dry eye still face limited options that fail to meet their expectations,” said Dr. Marjan Farid, Professor of Ophthalmology at the University of California, Irvine. “TRYPTYR is the first treatment that targets corneal nerves to directly stimulate tear production—a critical breakthrough for addressing a root cause of the disease.”
Although the precise mechanism of action is not fully understood, preclinical studies suggest that acoltremon activates TRPM8 thermoreceptors, triggering nerve signaling that increases basal tear production.
TRYPTYR will be offered in single-dose vials, with a recommended usage of one drop per eye twice daily. Alcon expects to make the product available in the U.S. beginning in the third quarter of 2025, with plans to expand into additional markets over time.
