FDA Approves Incision-Free Topical Therapy Epioxa for Keratoconus

The US Food and Drug Administration (FDA) has approved Epioxa, an incision-free alternative to cross-linking procedures to treat adult patients with keratoconus.

Announced on October 20, 2025, by parent company Glaukos Corporation, the approval is based on results from 2 prospective, randomized, multicenter, double-masked, phase 3 pivotal trials. Both of these trials achieved their prespecified primary efficacy endpoints, demonstrating the favorable tolerability and safety profiles of Epioxa.1

“Keratoconus is currently an underdiagnosed and undertreated disease. For keratoconus patients who are fortunate enough to be diagnosed, the current standard-of-care requires removal of the epithelium, the top layer of the cornea. The pain and extended healing time associated with the current surgical procedure are major barriers to adoption,” W. Barry Lee, MD, corneal specialist at Eye Consultants of Atlanta and president of the Cornea Society, said in a statement. “As an incision-free treatment that does not require removal of the epithelium, I expect the newly approved Epioxa treatment to address both of these major concerns.”1

Generally diagnosed in a patient’s teenage years, keratoconus is characterized by progressive thinning and weakening of the cornea. Untreated keratoconus can result in loss of vision and complete blindness. It is also a leading cause of corneal transplant in the US. Roughly 90% of cases are bilateral, and around 20% of patients require corneal transplants.2

Epioxa is an oxygen-enriched topical therapeutic, bioactivated by UV light. It is sequentially administered during the cross-linking procedure to eliminate the pain associated with removal of the epithelium. It uses a proprietary, novel drug formulation designed to penetrate the epithelial layer, a stronger UV-A irradiation protocol and the ability to deliver increased levels of supplemental oxygen to enhance cross-linking.2

The 2 Epioxa trials randomly assigned >400 patients, with a primary efficacy endpoint of improvements in maximum corneal curvature (Kmax) at 12 months from baseline compared to placebo. Epioxa ultimately demonstrated a Kmax treatment effect of -1 diopter (D) (P <.0001), determined as prospectively defined least square mean Kmax change from baseline at the 12-month study endpoint. Additionally, Epioxa was well-tolerated across both trials, with no discontinuation due to adverse events.2

“The FDA approval of Epioxa ushers in a new standard-of-care for patients suffering from keratoconus with the first FDA-approved topical drug therapy that does not require removal of the corneal epithelium,” Thomas Burns, chairman and chief executive officer of Glaukos. “Epioxa is designed to significantly improve patient comfort and minimize recovery time, representing a game-changing new treatment for patients suffering from keratoconus.”1

According to the press release, Glaukos plans for Epioxa to be commercially available in the first quarter of 2026. Additionally, further details will be provided on the approval and related matters in a conference call on October 29, 2025.1

References

1. Glaukos Corporation. Glaukos Announces FDA Approval of Epioxa. BusinessWire. October 20, 2025. Accessed October 20, 2025. https://www.businesswire.com/news/home/20251020818094/en/Glaukos-Announces-FDA-Approval-of-Epioxa

2. Glaukos Corporation. Glaukos Announces Positive Topline Outcomes in Phase 3 Confirmatory Trial for Epioxa, Achieving Primary Efficacy Endpoint and Demonstrating Favorable Tolerability and Safety. BusinessWire. October 16, 2024. Accessed October 20, 2025. https://www.businesswire.com/news/home/20241016373490/en/Glaukos-Announces-Positive-Topline-Outcomes-in-Phase-3-Confirmatory-Trial-for-Epioxa-Achieving-Primary-Efficacy-Endpoint-and-Demonstrating-Favorable-Tolerability-and-Safety