The FDA has approved TRYPTYR® (acoltremon ophthalmic solution) 0.003%, a novel prescription eye drop developed by Alcon, for the treatment of both the signs and symptoms of the condition.

Dry eye disease is a chronic and often under-treated condition that affects an estimated 38 million people in the United States.¹ Dry eye disease is a complex condition that affects the surface of the eye and is marked by an imbalance in the tear film.² Despite its prevalence, fewer than 10% of diagnosed patients currently use a prescription therapy, in part due to slow onset of relief and challenges with treatment adherence.³

TRYPTYR is the first FDA-approved therapy to target TRPM8 receptors, thermosensitive ion channels found on corneal nerves. By activating these receptors, the drug is designed to stimulate natural tear production through neurosensory pathways. While the precise mechanism remains unclear, preclinical studies suggest TRPM8 activation can enhance basal tear secretion by stimulating the trigeminal nerve.

The FDA approval was based on results from two pivotal Phase III clinical trials, COMET-2 (NCT05285644) and COMET-3 (NCT05360966), which evaluated over 930 participants with a history of DED. In both trials, patients treated with TRYPTYR were significantly more likely to show an increase in natural tear production compared to those receiving a vehicle (placebo) drop. At Day 14, 42.6% of TRYPTYR-treated patients in COMET-2 and 53.2% in COMET-3 achieved at least a 10mm increase in Schirmer’s test scores, versus 8.2% and 14.4% respectively in the vehicle group (p<0.0001). Improvements were observed as early as Day 1 and sustained through Day 90.

TRYPTYR will be available in single-use vials, dosed as one drop per eye twice daily. Alcon plans to launch the product in the US during the third quarter of 2025, with international expansion anticipated in the future.

The long-term impact of TRYPTYR on patient outcomes and adherence will require continued observation in real-world settings.

References:

1.  Farrand KF, et al. Prevalence of Diagnosed Dry Eye Disease in the United States Among Adults Aged 18 Years and Older. Am J Ophthalmol. 2017;182:90–8.
2. Craig JP, et al. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017;15:276–83.
3. Holland EJ, et al. Summary of a Roundtable Discussion on Dry Eye Disease Treatment. Clin Ophthalmol. 2021;15:2053–63.

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Citation: FDA approves acoltremon ophthalmic solution for dry eye disease. touchOPHTHALMOLOGY.com. 9 June 2025.