04.27.2026

Glaukos’ CXL Therapy, Epioxa, Meets Primary Endpoint in Phase 3 Clinical Trial

Key Takeaways Results of a phase 3 confirmatory pivotal trial for Epioxa, an FDA-approved therapy for keratoconus, were published in Ophthalmology and Therapy Treatment with Epioxa led to a statistically significant improvement in Kmax at month 12  The safety profile for Epioxa was favorable, with no serious ocular adverse events and mild, transient treatment-emergent events Glaukos announced the online publication of a phase 3 confirmatory pivotal trial for Epioxa, an FDA-approved, epithelium-on, oxygen-enriched corneal cross-linking (CXL) therapy for the treatment of keratoconus.  The results, published in Ophthalmology and Therapy, showed that Epioxa met its primary endpoint, showing a statistically significant and clinically meaningful improvement in Kmax at month 12 (-0.5 D improvement in Epioxa-treated eyes versus +0.4 D worsening in the sham group).1 The difference between the two groups was a statistically superior -1.0 D (95% CI -1.3, -0.6; P < 0.0001). Keratoconus was slowed or halted in treated eyes, while sham/placebo eyes continued to show steepening, with consistent trends across age, sex, race, and baseline severity subgroups, including eyes with mild keratoconus.