FDA Approves Tryptyr Eye Drops for Treatment of Dry Eye Disease

The U.S. Food and Drug Administration (FDA) has granted approval to the innovative ophthalmic solution, Tryptyr (acoltremon), developed by Alcon, marking a significant advancement in dry eye disease management. This first-in-class eye drop functions as a TRPM8 receptor agonist, uniquely stimulating corneal sensory nerves to promote natural tear production quickly.

Dry eye disease treatment options have historically faced challenges such as slow onset of relief, limited efficacy, and poor patient adherence. Tryptyr aims to overcome these issues by directly addressing tear deficiency, a fundamental cause of dry eye symptoms.

The approval is supported by the results from two large Phase III clinical trials, COMET-2 and COMET-3, which involved over 930 participants with a history of dry eye. The trials demonstrated that Tryptyr significantly increased tear production as early as the first day of treatment. By day 14, a notable proportion of patients experienced a ≥10-mm increase in natural tear production — 42.6% in COMET-2 and 53.2% in COMET-3 — compared to only 8.2% and 14.4% respectively in the placebo group. These effects persisted through 90 days of treatment.

Common side effects reported in the studies included instillation site pain. Dr. Marjan Farid from the University of California, Irvine, highlighted the importance of new treatment options: "Many patients continue to face challenges with dry eye management, and Tryptyr offers a new approach by directly stimulating tear production."

Alcon plans to launch Tryptyr in the United States during the third quarter of 2025, providing a new option for patients seeking faster and more effective relief from dry eye symptoms.

This approval represents a promising development in ophthalmology, potentially improving quality of life for millions affected by dry eye disease.

(Source: https://medicalxpress.com/news/2025-06-fda-tryptyr-eye-dry-disease.html)