Alcon has received US Food and Drug Administration (FDA) approval for TRYPTYR (acoltremon ophthalmic solution) 0.003%.

TRYPTYR is a neuromodulator designed to stimulate the TRPM8 (transient receptor potential melastatin 8) cold-sensing receptors on corneal sensory nerves. Activation of these receptors is believed to enhance basal tear production by triggering trigeminal nerve signaling, although the precise mechanism of action remains undetermined, according to a press release.

The FDA approval was supported by data from 2 pivotal phase 3 studies—COMET-2 and COMET-3—which collectively enrolled more than 930 patients who had a history of dry eye disease. Participants were randomized 1:1 to receive either TRYPTYR or a vehicle control.

In COMET-2, 42.6% of TRYPTYR patients achieved at least a 10mm increase in Schirmer’s score by Day 14, compared with 8.2% in the vehicle group (P<.0001). In COMET-3, 53.2% of TRYPTYR patients met the same endpoint at Day 14 compared with 14.4% in the vehicle group (P<.0001).

TRYPTYR demonstrated statistically significant tear production as early as Day 1, as well as consistent efficacy through Day 90 in both trials, according to a press release.

TRYPTYR will be provided in single-dose vials, with a recommended regimen of 1 drop per eye, b.i.d. The medication should not be used while wearing contact lenses, but lenses may be reinserted 15 minutes after administration.

The most common adverse event observed in trials was instillation site pain, which was reported in approximately 50% of patients. Additional safety instructions include avoiding vial tip contact with the eye or other surfaces to prevent contamination and potential injury.

Alcon plans to launch TRYPTYR in the US market in the third quarter of 2025. Global market expansion is anticipated thereafter.

TRYPTYR’s approval provides clinicians with a new therapeutic option that offers both rapid onset and a novel mechanism of action for treating dry eye disease.

Source: Alcon