FDA Approves Glaukos' Epioxa: First Incision-Free Corneal Cross-Linking Therapy for Keratoconus

The U.S. Food and Drug Administration (FDA) has approved Glaukos’ New Drug Application (NDA) for Epioxa HD/Epioxa, marking a breakthrough in the treatment of keratoconus. Epioxa is now the first and only FDA-approved, incision-free, topical drug therapy for this progressive corneal disorder.

Topical Cross-Linking Without Epithelial Removal

Traditional corneal cross-linking treatments require removal of the corneal epithelium; a process associated with significant pain and longer recovery times. In contrast, Epioxa’s oxygen-enriched topical formulation, bioactivated by ultraviolet (UV) light, allows the corneal epithelium to remain intact.

According to Glaukos, this innovation delivers strong clinical efficacy while minimizing discomfort and reducing recovery time. The therapy is administered using two topical formulations, Epioxa HD and Epioxa, applied sequentially before UV activation in an oxygen-enhanced environment, streamlining and optimizing the procedure.

FDA Approval Backed by Robust Phase 3 Data

Epioxa’s approval was based on two pivotal Phase 3 randomized, multicenter, double-masked clinical trials involving more than 400 patients. Both studies successfully met their primary efficacy endpoints and showed favorable safety and tolerability profiles.

“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,” stated Thomas Burns, Chairman and CEO 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.”

Addressing Longstanding Barriers in Keratoconus Care

Keratoconus remains both underdiagnosed and undertreated, in part due to the invasiveness and recovery burden of current treatment options.

“The pain and extended healing time associated with the current surgical procedure are major barriers to adoption,” noted Dr. W. Barry Lee, corneal specialist at Eye Consultants of Atlanta and President of the Cornea Society. “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.”

Commercial Launch and Awareness Campaign Set for 2026

Glaukos plans to make Epioxa commercially available in the first quarter of 2026. Alongside the launch, the company will introduce a comprehensive patient awareness and access campaign aimed at improving early detection and reducing underdiagnosis of keratoconus. Key initiatives include:

       • Co-pay assistance programs to reduce financial barriers

       • Patient access support to streamline treatment pathways

       • Integrated education strategies for both patients and healthcare professionals

       • Awareness campaigns to promote earlier screening and diagnosis