Alcon Receives FDA Approval of Tryptyr for the Treatment of the Signs and Symptoms of Dry Eye Disease
Alcon announced that the 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). Tryptyr is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production.[3] Tryptyr is Alcon's first prescription pharmaceutical treatment to be approved by the FDA since becoming an independent, publicly traded eye care company in 2019 after its separation from Novartis. Alcon acquired the rights to the drug in 2022 through its acquisition of Aerie Pharmaceuticals for nearly $770 million.
“We look forward to making this new treatment available to millions of patients affected by dry eye disease. We believe Tryptyr is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy," David Endicott, CEO of Alcon, said in a company news release.
This approval is supported by two phase 3 clinical trials evaluating more than 930 patients (randomized 1:1 to Tryptyr or vehicle) with a history of DED.[1-2] In COMET-2 and COMET-3, up to four times more Tryptyr patients experienced at least a 10 mm increase in natural tear production at Day 14, compared to vehicle, 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 (both P<0.0001). Consistent results were observed at all timepoints through Day 90. Tryptyr demonstrated statistically significant natural tear production as early as Day 1. In clinical trials, the most common adverse reaction was instillation site pain (50%).
Studies in animals suggest that acoltremon, the active substance in Tryptyr, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for Tryptyr in DED is unknown, according to Alcon.
Tryptyr is available in single dose vials: one drop per eye, two times a day.
Alcon expects to launch Tryptyr in the US in the third quarter of 2025 and anticipates bringing Tryptyr to other markets in the future.
References
- Data on File for COMET-2 Phase 3 Study. Alcon 2025.
- Data on File for COMET-3 Phase 3 Study. Alcon 2025.
- TRYPTYR® US FDA Prescribing Information. 2025.