FDA approves Tryptyr eye drops for dry eye disease

The U.S. Food and Drug Administration has approved the first-in-class TRPM8 receptor agonist Tryptyr (acoltremon ophthalmic solution) for the treatment of signs and symptoms of dry eye disease. Approval of Tryptyr was granted to Alcon.

Currently, dry eye disease treatment options are limited due to slow therapeutic onset, patient dissatisfaction, and poor adherence. Tryptyr works by stimulating corneal sensory nerves to rapidly increase natural tear production. The ophthalmic solution will be available in single-dose vials with a recommended dosage of one drop in each eye twice a day.

Approval of Tryptyr was based on the results of two Phase III clinical trials (COMET-2 and COMET-3). More than 930 patients with a history of dry eye disease were randomly assigned (1:1) to Tryptyr or vehicle.

As early as day one, Tryptyr delivered statistically significant natural tear production. Patients taking Tryptyr (versus vehicle) experienced a ≥10-mm increase in natural tear production at day 14 (42.6% versus 8.2% in COMET-2; 53.2% versus 14.4% in COMET-3). The results were consistent across all timepoints through day 90. The most common adverse reaction reported by patients in both studies was instillation site pain.

“Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” Marjan Farid, M.D., a professor of ophthalmology at the University of California, Irvine, said in a statement.

“Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.”

Alcon anticipates launching Tryptyr in the United States during the third quarter of 2025.

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