FDA Approves Glaukos’ Epioxa as First Incision-Free Corneal Cross-Linking Therapy for Keratoconus
The FDA has approved Glaukos' new drug application (NDA) for Epioxa HD/Epioxa, making it the first and only FDA-approved, incision-free, topical drug therapy for keratoconus.
Unlike existing treatments that require removal of the corneal epithelium, Epioxa’s oxygen-enriched topical formulation, bioactivated by UV light, preserves the epithelium. This design eliminates the pain associated with epithelial removal, shortens recovery time, and maintains strong clinical efficacy, according to Glaukos.
The therapy uses two formulations—Epioxa HD and Epioxa—which are applied sequentially before UV activation in an oxygen-enhanced environment, enabling an optimized and streamlined procedure.
“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,” said Thomas Burns, Glaukos chairman and chief executive officer. “Epioxa is designed to significantly improve patient comfort and minimize recovery time, representing a game-changing treatment for patients suffering from keratoconus.”
In an interview with Eyewire News, Joseph Gilliam, President and Chief Operating Officer at Glaukos, talked about the importance of identifying patients with keratoconus, which is often underdiagnosed and not treated.
"One of the real challenges that we find with keratoconus today is it's so rarely diagnosed. For these patients who really are being threatened by a disease that can take away a significant portion or all of their sight, to see how few of them are actually being found, diagnosed and ultimately treated today is a real challenge facing all of us, including those of us at Glaukos as well as the providers who care," Mr. Gilliam said. "And we're going to try to take a meaningfully different and more significant investment in trying to move that needle and really change that for the benefit of these patients who deserve to be found and ultimately find their way towards a crosslinking therapy such as Epioxa."
The FDA’s approval of Epioxa was supported by data from two pivotal phase 3 randomized, multicenter, double-masked clinical trials enrolling more than 400 patients. Both studies met their primary efficacy endpoints and demonstrated favorable safety and tolerability.
“Keratoconus is an underdiagnosed and undertreated disease,” said W. Barry Lee, MD, corneal specialist at Eye Consultants of Atlanta and President of the Cornea Society. “The pain and healing time of the current standard-of-care are major barriers. As an incision-free treatment that preserves the corneal epithelium, Epioxa addresses both concerns.”
Glaukos said it plans to make Epioxa commercially available in the first quarter of 2026. The company will also launch a patient awareness and access campaign, focusing on reducing underdiagnosis and improving early detection of keratoconus. Key initiatives include:
Co-pay assistance programs to reduce financial barriers
Patient access support to streamline treatment pathways
Integrated education strategies for patients and healthcare professionals
Awareness campaigns to promote earlier screening and diagnosis
The approval of Epioxa follows Glaukos’ earlier FDA-approved therapy, Photrexa Viscous / Photrexa, which received orphan drug approval in 2016. That therapy, which involves epithelial removal, has been the first and only FDA-approved cross-linking treatment for keratoconus until now, supported by over 300 peer-reviewed studies validating its safety and efficacy.