Acoltremon: The first TRPM8 agonist approved for the treatment of dry eye disease

Dry eye disease (DED) is a common ocular surface disorder that markedly affects the quality of life (QoL) of patients. Conventional treatments for DED were unable to meet current medical needs. Acoltremon, a transient receptor potential melastatin 8 (TRPM8) agonist, was first approved by the US Food and Drug Administration on May 28, 2025 for treatment of the signs and symptoms of DED. Acoltremon activates TRPM8 receptors, thereby increasing tear production and providing a cooling sensation for symptom relief. Results of clinical trials demonstrated that 0.003% acoltremon markedly alleviated signs and symptoms of DED. Adverse events associated with acoltremon were primarily instillation site pain, and no serious ocular adverse events were noted. Acoltremon has multiple advantages: rapid onset of action, significant alleviation of dry eye signs and symptoms, and favorable safety and tolerability. In summary, the approval of acoltremon represents a new therapeutic perspective on the management of DED.