New Dry Eye Medication Class Debuts

Alcon says its newest dry eye drug can show improved tear production as early as day 1 of therapy, overcoming a key complaint about some interventions that require a ramp-up period. Photo: Alcon. Click image to enlarge. Topical dry eye therapy, initially dominated by immunomodulators for over 20 years, has begun to diversify in recent years, with steroids and lipid stabilizers now firmly part of the armamentarium as well. Yesterday, Alcon opened another new front with FDA approval of the drug acoltremon, the first in a class known as selective transient receptor potential melastatin 8 (TRPM8) agonists. Its brand name will be Tryptyr, (pronounced trip-tir) according to an Alcon press release. TRPM8 agonists activate trigeminal nerve signaling, leading to increased basal tear production. Recommended dosing is BID.Two Phase III clinical trials (COMET-2 and COMET-3) comprising 930 dry eye patients led to the approval. Roughly half of subjects receiving the test drug met the primary outcome of at least a 10mm increase in Schirmer score at day 14, up to a fourfold increase over controls treated with the vehicle only, according to the press release. Specifically, subjects achieving this outcome were as follows:COMET-2: 42.6% acoltremon vs. 8.2% vehicleCOMET-3: 53.2% acoltremon vs. 14.4% vehicleThe Alcon press release also states that some subjects treated with Tryptyr demonstrated statistically significant natural tear production as early as day 1. The company anticipates a US launch in the third quarter of 2025. Tryptyr will be supplied in preservative-free, single-use vials.