TRPM8 agonist demonstrates rapid improvement in dry eye disease
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WASHINGTON — A TRPM8 agonist demonstrated early onset of action in the treatment of signs and symptoms of dry eye disease, according to a study.
David L. Wirta, MD, presented data from the COMET-1 study, which explored the safety and efficacy of AR-15512 (Aerie Pharmaceuticals), at the American Society of Cataract and Refractive Surgery meeting.
“TRPM8 receptors are cold-sensitive thermoreceptors that play a key role in tear film homeostasis,” Wirta said. “AR-15512 is a potent and highly selective TRPM8 agonist. This product stimulates tear production and produces a cooling sensation.”
Researchers conducted a randomized, vehicle-controlled study comprising 369 patients with dry eye disease who were randomly assigned to receive one of two concentrations of the drug, 0.0014% or 0.003%, or vehicle control twice daily for 12 weeks.
The study’s efficacy measures included tear production, ocular surface staining, ocular redness and dry eye symptoms.
Patients in both drug-treated groups experienced a greater change from baseline in Schirmer’s score compared with vehicle at both day 1 and day 14 (all P < .0001). Treatment groups also had greater change from baseline in global symptom assessment in dry eye and visual analog scale scores compared with vehicle.
Wirta said patients in the treatment groups experienced improvement in various measures of daily living, such as reading books, ability to drive and depression. He said both formulations were safe and well tolerated by patients.
“This is a promising approach to dry eye therapy,” Wirta said. “The 0.003% has been selected for advancement to phase 3 development.”
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Wirta DL. Safety and efficacy of a TRPM8 agonist for the treatment of dry eye disease. Presented at: American Society of Cataract and Refractive Surgery meeting; April 22-26, 2022; Washington.
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