Glaukos Achieves Pipeline Milestone with Enrollment Completion in Phase 3 Confirmatory Trial for Epioxa (Epi-on)

Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the completion of enrollment and randomization in its second Phase 3 confirmatory pivotal trial for Epioxa (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus.

“The expeditious enrollment completion in the Epioxa Phase 3 confirmatory trial, which only commenced earlier this year, is a testament to the favorable risk-benefit profile of this next-generation therapy as well as our team’s hard work in bringing this important therapy one step closer to patients suffering from keratoconus, a sight-threatening corneal disease,” said Thomas Burns, Glaukos chairman and chief executive officer. “We appreciate the commitment and dedication of the clinical investigators, who played a vital role in helping to achieve this enrollment milestone ahead of our original timing expectations. We look forward to following these patients’ outcomes as we target a U.S. New Drug Application (NDA) submission for Epioxa by the end of 2024.”

The Epioxa multi-center, randomized, placebo and sham procedure controlled, Phase 3 confirmatory pivotal trial randomized 312 eyes and was designed to evaluate the safety and efficacy of Glaukos’ Epioxa therapy in impeding the progression of, and/or reducing maximum corneal curvature (Kmax) in eyes with progressive keratoconus. Kmax is an objective measurement of the steepest corneal curvature based on corneal topography, where an increasing Kmax denotes corneal steepening and keratoconus disease progression. The study eyes were randomized in a 2:1 ratio to receive Epioxa therapy or placebo and sham procedure control treatment. The study’s primary efficacy endpoint is the mean change in Kmax from baseline to Month 12. Based on an agreement with the U.S. Food and Drug Administration (FDA), the study will be considered a success if the difference between the treatment and control arm in the primary efficacy endpoint is statistically significant and the difference is ≥ 1.0 diopter (D).