Alcon, the world’s leading eye care company, announced that TRYPTYR® (acoltremon ophthalmic solution) 0.003% has received approval from theFood and Drug Administration (FDA). It is indicated to treat the symptoms and signs of Dry Eye Disease (DED), previously known as AR-15512.
TRYPTYR is a first-in-class TRPM8 receptor agonist that increases natural tear production by stimulating corneal sensory nerves. DED is a multifaceted disorder caused by increased tear evaporation or decreased tear production, which results in a lack of natural tears. A number of widely used DED therapy approaches show drawbacks such as sluggish onset, poor adherence, and patient sadness.
The CEO of the Alcon company stated that this is a big achievement, marking the company’s first prescription pharmaceutical treatment, which is approved under the FDA after registering separately. The FDA approval was supported by two Phase 3 clinical trials (COMET-2 and COMET-3), which evaluated over 930 patients with DED in randomized 1:1 trials comparing TRYPTYR to a vehicle control.
On Day 14, when compared to the vehicle, there are four times TRYPTYR patients observed in COMET-2 and COMET-3 has minimum 10 mm increase in natural tear production. The results with 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 are recorded. The outcomes remained consistent across all timepoints through Day 90. TRYPTYR demonstrated a statistically significant increase in natural tear production as early as Day 1. TRYPTYR is the first eye drop that directly addresses tear deficit, which is noted as a proven cause of DED, by stimulating corneal nerves.
Transient receptor potential melastatin 8 (TRPM8) thermoreceptors may be agonistically stimulated by acoltremon, the active ingredient in TRYPTYR, according to animal studies. The third quarter of 2025 is when Alcon plans to introduce TRYPTYR in the United States, and it plans to expand to additional markets in the future. TRYPTYR is available in single-dose vial form, with the quantity of one drop in both eyes twice daily.
Patients should be advised not to touch the tip of the vial to their eyes or other surfaces to prevent contamination and possible eye injury. Before applying the solution, any patient wearing contact lenses should remove them. Lenses can be inserted again in 15 minutes after TRYPTYR is administered.
DED is considered the most prevalent ocular surface condition, which affects around 38 million adults in the United States and an additional 719 million people worldwide. Many eye care specialists believe that the current prescription choices for DED are not sufficient because of their poor tolerability, late onset of action, and limited efficacy.
Reference: Alcon. Alcon Announces FDA Approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease. Published May 28, 2025. Accessed June 2, 2025. Alcon – Alcon Announces FDA Approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease
