Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, today announced completion of patient enrollment in its Phase 2 clinical study evaluating GLK-321 for the treatment of Demodex blepharitis.

GLK-321 is an investigational drug candidate using Glaukos’ proprietary iLution platform, a novel ophthalmic drug-delivery system utilizing patented, cream-based drug formulations applied to the outer surface of the eyelids to enable dropless transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. The platform is designed to improve patient compliance, offer faster onset of action, and reduce side effects and patient burden often associated with traditional eye drop regimens. GLK-321’s active pharmaceutical ingredient is physostigmine.

"Completion of enrollment in this Phase 2 study marks an important milestone in the advancement of our iLution pharmaceutical platform and broader ocular surface disease pipeline," said Thomas Burns, Glaukos chairman and chief executive officer. "Demodex blepharitis represents a large, growing, and significantly underpenetrated market opportunity, with potentially millions of patients who remain undiagnosed or untreated today. As awareness and diagnosis of this chronic condition continue to increase, we believe there is a substantial need for differentiated therapeutic approaches that expand treatment options and improve patient access to care."

Demodex blepharitis is a chronic eyelid disease associated with Demodex mite infestation and is characterized by eyelid inflammation, irritation, redness, itching, and the presence of collarettes at the base of eyelashes. The disease is believed to be significantly underdiagnosed and can adversely affect ocular surface health and patient quality of life.

The Phase 2 randomized, double-masked, placebo-controlled, dose-ranging, parallel-group, multi-center trial is designed to evaluate the safety, tolerability, and efficacy of three different dose levels of GLK-321 in patients with Demodex blepharitis. The study randomized 275 patients across clinical sites in the United States, with the primary efficacy endpoint assessing the proportion of study eyes achieving elimination of collarettes following six weeks of treatment.