Glaukos Announces Positive Clinical Updates for Several Corneal Health Pipeline Programs
Glaukos announced positive clinical updates for several of its corneal health pipeline programs, including the commencement of subject enrollment in a second phase 3 confirmatory trial for Epioxa (Epi-on), and initial results from the company’s phase 2a clinical trial for GLK-301 (iLution, dry eye disease), according to a company news release.
“These clinical updates represent meaningful milestones for two of our key corneal health pipeline programs and we look forward to continuing to advance both of these important programs forward in 2023,” Thomas Burns, Glaukos chairman and chief executive officer, said in a company news release. “We continue to successfully invest in and advance our robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.”
Glaukos commenced subject enrollment in its second phase 3 confirmatory pivotal trial for Epioxa (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus. Glaukos plans to randomize approximately 290 subjects in this trial and is targeting enrollment completion by the end of 2023. The FDA confirmed Glaukos’ first phase 3 pivotal trial for Epioxa, which met the prespecified primary efficacy endpoint, would be adequate to support the submission and review of an eventual new drug application (NDA), in conjunction with this second trial. As Glaukos continues to advance its clinical plans for Epioxa, it remains well-positioned to serve keratoconus patients with its first-generation corneal cross-linking therapy, Photrexa, or Epi-off, which remains the only FDA-approved treatment shown to slow and halt the progression of keratoconus.
Glaukos also announced promising topline results from its phase 2a first-in-human clinical trial for GLK-301 (iLution-dry eye disease) for the signs and symptoms of DED. GLK-301 is a sterile ophthalmic topical cream to be applied to the eyelids for the treatment of signs and symptoms of DED. The trial’s endpoints included the evaluation of multiple signs and symptoms characteristic of DED. Topline phase 2a outcomes for GLK-301 demonstrated improvement in the quality of tear film (tear break-up time) with corresponding improvement in quality of vision (reduction in blurred vision). Based on these encouraging observations, Glaukos plans to advance GLK-301 into a phase 2b clinical trial targeted to begin in 2023.
The phase 2a multicenter, randomized, double-masked, placebo-controlled trial enrolled 218 subjects across clinical sites in the United States and was 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 subjects diagnosed with 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. The cream formulation acts as a depot allowing pilocarpine to be delivered through the dermis of the eyelid to the eye.