United States: In the United States, the Food and Drug Administration (FDA) has introduced Tryptyr (acoltremon ophthalmic solution), the first TRPM8 receptor agonist for dry eye disease.
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At this time, dry eye treatments encounter problems due to slow initial results, patients being disappointed with them, and poor compliance.
The medication stimulates nerves in the eyes to lead to a quick rise in tear production, US News reported.
The ophthalmic solution will be found in single-dose vials with a dosage recommendation of one drop put into each eye two times a day.
The #FDA has approved Tryptyr (acoltremon ophthalmic solution 0.003%) for treating dry #eye disease. As a first-in-class TRPM8 receptor agonist, it stimulates corneal nerves to enhance natural tear production, offering rapid symptom relief.
— Pharmacy Times (@Pharmacy_Times) May 30, 2025
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The approval of Tryptyr was decided on by reviewing the outcomes of two phase 3 clinical trials (COMET-2 and COMET-3).
Among the patients with a history of dry eye, almost 1,000 were randomly distributed (1:1) to receive Tryptyr or the placebo.
Tryptyr started producing statistically significant natural tears from day 1.
The majority of participants in both clinical trials said that the most concerning side effect was pain where the medicine was given.
According to Marjan Farid, M.D., a professor of ophthalmology at the University of California, Irvine, “Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” US News reported.
“Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease,” he added.
Alcon obtained approval to sell Tryptyr. Alcon believes launching Tryptyr in the United States will take place in the third quarter of 2025.