Glaukos Corporation has released topline results from the first-in-human phase 2a clinical trial on GLK-301 for treatment of dry eye disease (DED) signs and symptoms.
Tell me about GLK-301.
GLK-301 is Glaukos’s first investigational drug candidate designed using Glaukos’ iLution platform of patent cream-based drug formulations.
The cream is applied to the outer surface of the eyelid, delivering pharmaceutically-active compounds to treat eye disorders, including DED and presbyopia, along with potential future indications for Demodex blepharitis and ocular hypertension/glaucoma. Its formulation allows pilocarpine to be administered through the dermis of the eyelid to the eye. (via)
How about the trial?
The phase 2a multi-center, randomized, double-masked, placebo-controlled trial enrolled 218 patients diagnosed with DED across the U.S.
It was designed to evaluate the safety and efficacy of three separate dose levels of GLK-301 applied twice a day to the eyelids—compared to a placebo—for 28 days, followed by a 14-day safety follow-up time period.(via)
What does the data show so far?
Endpoints included the evaluation of DED signs and symptoms. Topline results indicate improvement in the tear film break-up time (TFBUT) with a 43% change from baseline at day 28 compared to placebo, which was 22%, respectively.
In conjunction with the TFBUT sign data, there was a correlating quality of vision improvement, defined as a reduction in blurred vision symptom, measured using a visual analog scale.
Significance of this?
The iLution transdermal delivery platform has the possibility for ease of administration which could drive better patient compliance comparatively to conventional prescription eye drops.
What’s next?
Based on the data, Glaukos is moving forward with plans to advance GLK-301 to a phase 2b clinical trial. The trial is slated to commence later in 2023.