Two novel, dropless technologies for keratoconus and dry eye disease make major advances with more to come later in 2023.
Today, Glaukos Corporation announced clinical updates for several studies in their Corneal Health pipeline programs. Enrollment has begun for a second Phase 3 confirmatory trial for Epioxa (Epi-on), and promising Phase 2a results for GLK-301 (iLution – Dry Eye Disease) has encouraged Glaukos to advance GLK-301 into a Phase 2b clinical trial, which will begin in 2023.
“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 press 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.”
Enrollment began for the second Phase 3 confirmatory pivotal trial for Epioxa (Epi-on), which is a next-generation corneal cross-linking therapy for keratoconus. Its predecessor, Photrexa or Epi-off, is the only FDA-approved treatment to slow and halt the progression of keratoconus.
Glaukos intends to investigate Epioxa in 290 randomized subjects, all of whom should be enrolled by the end of 2023. Previously, Glaukos’ first Phase 3 pivotal trial for Epioxa met the pre-specified primary efficacy endpoint and had been confirmed by the FDA that the results would support the submission and review of a new drug Application (NDA) with support from this second trial.
Additionally, Glaukos shared topline results from the first-in-human Phase 2a clinical trial for GLK-301 (iLution – Dry Eye Disease). GLK-301 is designed to treat the signs and symptoms of dry eye disease (DED). The sterile ophthalmic topical cream is applied to the eyelids twice daily, and the results demonstrated an improved quality of tear film, or tear break-up time, and a correlating improvement in quality of vision, or reduction in blurred vision.
In total, 218 subjects were enrolled in the Phase 2a multi-center, randomized, double-masked, placebo-controlled trial, which spanned across clinical sites in the United States. The trial investigated the safety and efficacy of 3 dose levels of GLK-301 administered twice daily to eyelids vs. placebo over 28 days with a 14-day safety follow-up period.
GLK-301 is the first drug candidate to leverage Glaukos’ iLution platform’s patented cream-based drug formulations. The dropless formula is cream-based, to be applied to the outer surface of the eyelid for transdermal delivery of active compounds to treat eye disorders. The cream delivers pilocarpine through the dermis of the eyelid to the eye, correcting issues without drops.
Based on the positive topline results, Glaukos will move forward with GLK-301, with plans to begin a Phase 2b clinical trial in 2023.