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news.Alcon has received the US Food and Drug Administration (FDA) approval for its Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of signs and symptoms of Dry Eye Disease (DED).
Tryptyr is intended for the treatment of Dry Eye Disease. Credit: Towfiqu barbhuiya on Unsplash.
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Previously known as AR-15512, Tryptyr is a transient receptor potential melastatin 8 (TRPM8) receptor agonist that stimulates corneal sensory nerves to increase production of natural tears rapidly. It is available in single-dose vials, with one drop recommended per eye twice daily.
DED is a complex condition characterised by a deficiency in natural tears, which can result from decreased tear production or increased evaporation of tears.
The active ingredient in Tryptyr , acoltremon, functions as an agonist of TRPM8 thermoreceptors. Stimulation of these receptors showed to activate trigeminal nerve signalling pathways that lead to enhanced basal tear production.
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 DED. We believe Tryptyr is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy.”
The FDA’s approval was supported by two Phase III clinical trials comparing Tryptyr against a vehicle control. These randomised studies were carried out in more than 930 patients with DED history.
In the COMET-2 and COMET-3 trials, up to four times more patients receiving the therapy experienced a minimum of a 10mm increase in production of natural tears by day 14 compared to those on the vehicle, 42.6% versus 8.2% in COMET-2 and 53.2% versus 14.4% in COMET-3.
Consistent results were observed across all timepoints through day 90, with increase in natural tear production noted as early as day one post-treatment initiation.
Alcon anticipates to launch Tryptyr in the US during the third quarter of 2025 and plans to introduce it into additional markets thereafter.
