Glaukos Corporation announced that it has enrolled the first patient into a Phase 2 clinical trial of GLK-301 for the treatment of signs and symptoms of Dry Eye Disease (DED). GLK-301 is the first investigational drug candidate utilizing Glaukos' iLution platform's patented cream-based drug formulations that are applied to the outer surface of the eyelid for dropless transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. GLK-301's active pharmaceutical ingredient is pilocarpine.

The Phase 2 multi-center, randomized, double-masked, placebo-controlled trial is designed to evaluate the safety and efficacy of three different dose levels of GLK-301 administered twice daily (BID) to the eyelids versus placebo over 28 days, followed by a 14-day safety follow-up period, in patients diagnosed with DED. Endpoints will include standard signs and symptoms characteristic of DED. The company anticipates it will enroll approximately 200 DED patients in the study across clinical sites in the United States.

Additionally, approximately 20 patients with a diagnosis of DED due to Sjogren's Syndrome will also be enrolled. GLK-301 is a sterile ophthalmic topical cream to be applied to the eyelids for the treatment of signs and symptoms of DED. The cream formulation acts as a depot allowing pilocarpine to be delivered through the dermis of the eyelid to the eye.