Key Takeaways

• Results of a phase 3 confirmatory pivotal trial for Epioxa (Glaukos), 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 (-0.5 D improvement in Epioxa-treated eyes versus +0.4 D worsening in the sham group).
• 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, in Ophthalmology and Therapy. In this paper, Beckman et al shared the results of the prospective, multicenter, randomized, double-masked, sham procedure/placebo controlled clinical trial evaluating the safety and efficacy of Epioxa.

The results 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.

In addition, the safety profile was favorable with no serious ocular adverse events and mild, transient treatment-emergent events. No clinically meaningful changes were observed in corneal thickness, endothelial cell count, IOP, or macular thickness, supporting the procedure’s tolerability and safety.

1. Beckman KA, Parkhurst GD, Lee JH, et al. Randomized, controlled study to evaluate the safety and efficacy of oxygen-enriched epithelium-on corneal cross-linking for the treatment of keratoconus. Ophthalmol Ther. 2026;15(4):1463-1484.