Switching From Restasis to TRYPTYR

Overview

Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.

Acoltremon 0.003% was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor potential melastatin 8 (TRPM8) agonist for the treatment of DED.9, 10 Acoltremon acts by activating TRPM8 receptors expressed on the neurons of the ophthalmic division of the trigeminal nerve, which is the nerve that innervates the cornea and eyelid.9 This drugs subsequently modulates cold thermoreceptor to increase tear production and promote a cooling sensation, which promotes symptomatic relief. While acoltremon 0.003% has been significantly shown to improve the signs and symptoms of DED patient, the community currently lacks data describing how patients who are being treated with Restasis (cyclosporine ophthalmic emulsion), yet are not having their expectations met with the drug, respond to being switched to acoltremon 0.003%. These data are important because they could demonstrate that a DED drug with a different mechanism of action can still be effective when another treatment does not meet the patient's expectations. Thus, the purpose of this study is to determine if acoltremon 0.003% can significantly improve the signs and symptoms of DED suffers who are not currently being successfully treated with Restasis.