Glaukos announces clinical updates for several corneal disorders

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, and promising initial results from the company’s Phase 2a clinical trial for GLK-301. Glaukos commenced subject enrollment in its second Phase 3 confirmatory pivotal trial for Epioxa, 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. As a reminder, the FDA has confirmed Glaukos’ first Phase 3 pivotal trial for Epioxa, which met the pre-specified primary efficacy endpoint, would be adequate to support the submission and review of an eventual New Drug Application, 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(R), or Epi-off(TM), which remains the only FDA-approved treatment shown to slow and halt the progression of keratoconus."