FDA Approves Glaukos’ Epioxa, First Incision-Free Drug for Keratoconus

Glaukos Corporation announced that the U.S. Food and Drug Administration (FDA) has approved its novel corneal cross-linking therapy, Epioxa™ (Epioxa™ HD / Epioxa™), marking a major advancement in the treatment of keratoconus—a rare, progressive eye disease that can lead to blindness if left untreated.

Epioxa becomes the first FDA-approved topical drug therapy for keratoconus that does not require removal of the corneal epithelium, the protective outer layer of the eye. Unlike conventional cross-linking procedures that involve epithelial removal, Epioxa is an incision-free, oxygen-enriched, UV light-activated treatment designed to reduce pain, minimize recovery time, and improve patient outcomes.

“This approval marks a new standard of care for keratoconus patients,” said Thomas Burns, Chairman and CEO of Glaukos. “Epioxa is designed to significantly improve patient comfort and access to treatment, helping to address a disease that is both underdiagnosed and undertreated.”

Dr. W. Barry Lee, President of the Cornea Society, called the approval a breakthrough: “The current procedure for treating keratoconus can be painful and requires a long recovery. Epioxa, which leaves the epithelium intact, has the potential to remove those barriers and expand access to care.”

The FDA approval was supported by two pivotal Phase 3 trials involving over 400 patients, which demonstrated both efficacy and a favorable safety profile. Glaukos plans to launch Epioxa in the first quarter of 2026, accompanied by significant investments in patient education, access programs, and early diagnosis initiatives.

Keratoconus affects mostly younger individuals and can lead to severe vision loss. While current treatments like glasses or contact lenses manage symptoms, they do not stop disease progression. Glaukos’ original cross-linking therapy, Photrexa®, approved in 2016, was the first and only FDA-approved treatment until now—but required epithelial removal.

Epioxa is set to expand treatment options significantly, especially for patients who were previously reluctant to undergo invasive procedures.