Alcon has secured approval from the US Food and Drug Administration (FDA) for Tryptyr (acoltremon ophthalmic solution) 0.003% to treat symptoms of Dry Eye Disease (DED).
Tryptyr is a first-in-class TRPM8 receptor agonist that rapidly stimulates natural tear production, providing a new option for patients suffering from the multifactorial condition.
The FDA approval is based on two Phase 3 trials, COMET-2 and COMET-3, involving over 930 patients with a history of DED.
Results showed up to four times more patients using Tryptyr experienced a significant increase in tear production compared to those using a vehicle.
By Day 14, 42.6% of patients in COMET-2 and 53.2% in COMET-3 showed improvements, compared to 8.2% and 14.4% in the vehicle groups, respectively.
In the Phase 3 trials, Tryptyr showed rapid tear production, with significant results.
Alcon CEO David Endicott said: “Today marks a tremendous milestone for Alcon as Tryptyr becomes our first prescription pharmaceutical treatment to be approved by the FDA since becoming an independent, publicly traded eye care company.
“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.”
DED is characterised by a deficiency in natural tears, causing discomfort and vision issues, and existing treatments often face challenges such as slow onset and patient dissatisfaction.
Tryptyr’s active ingredient, acoltremon, acts as an agonist of TRPM8 thermoreceptors, stimulating corneal sensory nerves to enhance tear production.
While the exact mechanism in DED remains unknown, studies indicate that TRPM8 activation increases basal tear production through trigeminal nerve signalling.
Alcon plans to launch Tryptyr in the US in the third quarter of 2025, with plans to expand to other markets.
The dry eye disease medication will be available in single-dose vials, with a recommended dosage of one drop per eye, twice daily.
University of California, Irvine professor of ophthalmology Marjan Farid said: “Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options.
“Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of Dry Eye Disease.”
