Alcon’s Tryptyr Approved by FDA for Dry Eye Disease Treatment

Alcon has received U.S. FDA approval for Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of dry eye disease (DED). Tryptyr is a first-in-class TRPM8 receptor agonist and represents a novel treatment option targeting neuromodulation to stimulate natural tear production.

FDA Approval Marks New Development in Alcon’s Prescription Portfolio

Tryptyr marks the first FDA-approved prescription pharmaceutical from Alcon since the company became an independent, publicly traded eye care company in 2019, following its separation from Novartis. Alcon acquired Tryptyr through its 2022 acquisition of Aerie Pharmaceuticals in a deal valued at approximately $770 million.

“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,”
said David Endicott, CEO of Alcon.

Clinical Trial Results Support FDA Approval

The FDA’s approval is supported by data from two Phase 3 clinical trials—COMET-2 and COMET-3—which evaluated over 930 patients with a history of DED, randomized 1:1 to receive Tryptyr or vehicle.

Key findings include:

• Day 14 tear production improvement:

• COMET-2: 42.6% (Tryptyr) vs. 8.2% (vehicle)

• COMET-3: 53.2% (Tryptyr) vs. 14.4% (vehicle)

• (Both P < 0.0001)

• Tryptyr demonstrated statistically significant improvement in natural tear production as early as Day 1 and maintained results through Day 90.

• The most common adverse reaction reported in clinical trials was instillation site pain (50%).

Novel Mechanism of Action: TRPM8 Receptor Agonism

Acoltremon, the active ingredient in Tryptyr, is believed to act as an agonist of TRPM8 thermoreceptors—sensory receptors involved in cool-temperature detection. Preclinical studies suggest that TRPM8 stimulation activates trigeminal nerve pathways, enhancing basal tear secretion.

Despite these findings, Alcon notes that the exact mechanism of action of Tryptyr in dry eye disease remains unknown.