Key Takeaways

• Glaukos completed patient enrollment of a phase 2 clinical trial evaluating GLK-321, its investigational drug candidate for the treatment of Demodex blepharitis.
• GLK-321 uses a patented, cream-based drug formulation applied to the outer surface of the eyelids to enable dropless, transdermal delivery of pharmaceutically active compounds.
• The phase 2 trial will evaluate safety, tolerability, and efficacy of three different dose levels of GLK-321 in 275 patients with Demodex blepharitis across multiple clinic sites.

Glaukos 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, an ophthalmic drug-delivery system using 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, Chairman and CEO of Glaukos.

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 will include 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 6 weeks of treatment.