Acoltremon: FDA Approves New Dry Eye Treatment
- The food and Drug Administration has given the green light to acoltremon ophthalmic solution 0.003% (Tryptyr, Alcon) for treating the signs and symptoms of dry eye disease (DED).
- Dry eye disease, a multifactorial condition, arises from insufficient natural tear production or increased tear evaporation.
- Over half of those surveyed report difficulty driving at night, while others struggle with reading, computer use, or watching TV.
FDA Approves Tryptyr for Dry Eye Disease Treatment
Updated May 29, 2025
The food and Drug Administration has given the green light to acoltremon ophthalmic solution 0.003% (Tryptyr, Alcon) for treating the signs and symptoms of dry eye disease (DED). This first-in-class treatment works as a transient receptor potential melastatin 8 (TRPM8) receptor agonist, boosting natural tear production by stimulating corneal sensory nerves.
Dry eye disease, a multifactorial condition, arises from insufficient natural tear production or increased tear evaporation. Existing treatments often present challenges like slow onset and low patient satisfaction. Studies reveal that onyl a fraction of DED patients, around 13%, feel their condition is well-managed.
DED can significantly impair daily life. Over half of those surveyed report difficulty driving at night, while others struggle with reading, computer use, or watching TV. Patients frequently enough try various remedies with limited success,highlighting the need for more effective and accessible treatments for dry eye disease.
The FDAS approval of acoltremon ophthalmic solution 0.003% stems from two Phase 3 clinical trials involving over 930 participants with a history of DED. Participants were randomized to receive either the solution or a vehicle in a 1:1 ratio. The COMET-2 and COMET-3 trials showed that acoltremon led to a notable increase in natural tear production. At day 14,up to four times more patients in the acoltremon group experienced at least a 10 mm increase in tear production compared to the vehicle group. These findings remained consistent through day 90, with statistically significant tear production observed as early as day 1.
“Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” said Dr. Marjan Farid,a professor of ophthalmology at the University of california,Irvine. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.”
Animal studies suggest acoltremon activates TRPM8 thermoreceptors, which in turn stimulate trigeminal nerve signaling, leading to increased tear production.
What’s next
Pharmacists play a crucial role in helping patients manage dry eye disease, especially with new options like acoltremon. they can educate patients on proper usage, potential side effects like instillation site pain, and lifestyle adjustments to complement the medication. By providing comprehensive counseling, pharmacists can optimize the benefits of acoltremon and improve the quality of life for individuals with DED.