Glaukos 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 using 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-centre, randomised, 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 enrol 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.
We believe our iLution platform has the potential to address the major unmet need for patients suffering from dry eye disease and other chronic eye diseases
“Dry eye disease is a common ocular inflammation condition with high unmet clinical need, representing one of the world’s largest ophthalmic markets worldwide. Today’s announcement represents a significant milestone in the development of our iLution platform and for our company,” said Thomas Burns, Glaukos president and chief executive officer. “We believe our iLution platform has the potential to address the major unmet need for patients suffering from dry eye disease and other chronic eye diseases by providing an effective, easy to administer, safe, dropless transdermal therapeutic. We are delighted to have the opportunity to explore what GLK-301 can do for DED patients in our Phase 2 trial.”
GLK-301 is a sterile ophthalmic topical cream, 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.