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2h ago

FDA Approves Glaukos’ Epioxa, First Epithelium-On Corneal Cross-Linking Therapy in the U.S.

Glaukos targets a Q1 2026 launch following Phase 3 trials that met efficacy and safety endpoints.

Around 20% of untreated keratoconus patients require corneal transplants, according to Glaukos. George Pachantouris via GettyImages.
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Overview

  • Epioxa uses sequential bioactivated riboflavin eye drops with ultraviolet activation in an oxygen-enriched environment while preserving the corneal epithelium.
  • The FDA decision is supported by two randomized Phase 3 studies enrolling more than 400 patients that achieved primary endpoints in maximum corneal curvature improvement at 12 months and showed tolerability and safety.
  • Glaukos plans to make the treatment commercially available in the United States in the first quarter of 2026.
  • Expert commentary highlighted potential advantages over epithelium-off cross-linking, including less pain, faster visual recovery, and lower risks such as corneal haze or infection.
  • The approval follows Glaukos’ earlier Photrexa cross-linking therapy, which requires epithelial removal, and the company’s shares rose about 1.8% at the open after the news.