Key Takeaways

• - TRPM8 receptors, which are expressed on corneal thermosensory neurons, are key regulators of basal tear production. Acoltremon is a selective TRPM8 agonist

   

• - In two identical randomized, controlled clinical trials that included 931 patients with dry eye disease, acoltremon ophthalmic solution 0.003% demonstrated statistically significant increases in tear production compared to vehicle on Day 14. Effects were rapid (Day 1) and sustained (Day 90)

   

• - Reductions in symptoms on Day 28 were statistically significant in COMET-2 and directionally in favor of acoltremon in COMET-3

   

• - Numerical reductions in corneal and conjunctival staining (exploratory endpoints) were also observed as early as Day 7

   

• - Instillation-site pain (burning/stinging) was reported in half of patients receiving acoltremon in COMET-2 and COMET-3. The vast majority of cases were mild in severity