FDA

Novel corneal cross-linking therapy OK’d for keratoconus

October 27, 2025

Brand name: Epioxa

Generic name: riboflavin 5’-phosphate

Manufacturer: Glaukos Corporation

Approval date: October 20, 2025

FDA approved Epioxa HD 0.239% / Epioxa 0.177% (riboflavin 5’-phosphate ophthalmic solution) for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients ≥13 years of age, in conjunction with the O₂n System and the Boost Goggles.

Efficacy

Approval was based on results from two prospective, randomized, multicenter, double-masked, phase 3 trials (NCT03442751; NCT05759559) that randomized >400 patients. Both trials successfully achieved their pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.

Safety

The most common adverse reaction was conjunctival hyperemia (31%). Other adverse reactions, occurring in 5% to 25% of eyes included: corneal opacity, photophobia, punctate keratitis, eye pain, eye irritation, increased lacrimation, corneal epithelium defect, eyelid edema, corneal striae, visual acuity reduced, dry eye, and anterior chamber flare.

Sources:

Epioxa (riboflavin 5-phosphate ophthalmic solution) [package insert]. Food and Drug Administraton. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219910s000lbl.pdf Revised October 2025. Accessed October 24, 2025.

Glaukos announces FDA approval of Epioxa™. [News release]. 2025. https://investors.glaukos.com/news/news-details/2025/Glaukos-Announces-FDA-Approval-of-Epioxa/default.aspx