The FDA has approved Alcon’s Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of dry eye disease (DED).

A first-in-class, transient receptor potential melastatin 8 (TRPM8) receptor agonist or neuromodulator, Tryptyr is designed to stimulate corneal sensory nerves to rapidly increase natural tear production. Approval was supported by two phase 3 clinical trials (Comet-2 and Comet-3) involving more than 930 patients (randomised 1:1 to Tryptyr or vehicle) with a history of DED.

Results showed up to four times more patients receiving Tryptyr experienced at least a 10mm increase in natural tear production at day 14 compared to vehicle, 42.6% versus 8.2% of patients in Comet-2 and 53.2% versus 14.4% in Comet-3 (both p<0.0001). Consistent results were observed at all timepoints through to day 90, with statistically significant natural tear production as early as day one, reported Alcon.

TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production, said the company, adding that the exact mechanism of action for Tryptyr in DED is unknown.