Glaukos Corporation has announced that the FDA has approved its Epioxa™ HD / Epioxa™ (Epioxa) New Drug Application, marking it as the first and only FDA-approved, incision-free topical therapy for keratoconus.
Epioxa is a non-invasive alternative to traditional corneal cross-linking, which typically requires removal of the corneal epithelium. The oxygen-enriched topical drug, bioactivated by UV light, is designed to eliminate procedure-related pain, streamline treatment, and shorten recovery while maintaining strong clinical efficacy.
Keratoconus affects mainly younger patients and can lead to visual impairment or blindness if untreated. Conventional treatments such as glasses or contact lenses address vision symptoms only, while traditional cross-linking procedures require epithelium removal, which can cause pain and long healing times. Epioxa uses two formulations — Epioxa HD and Epioxa — that are sequentially applied during the cross-linking procedure, followed by UV activation in an oxygen-enriched environment.
The FDA approval was based on two multicenter, randomized, double-masked Phase III pivotal trials involving more than 400 patients, both of which met their primary efficacy endpoints and demonstrated favorable safety and tolerability profiles.
“Epioxa is designed to significantly improve patient comfort and minimize recovery time, representing a game-changing new treatment for patients suffering from keratoconus.," said Glaukos Chairman and CEO Thomas Burns.
“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 procedures are major barriers to adoption," explained W. Barry Lee, 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.”
Glaukos plans to commercially launch Epioxa in the first quarter of 2026, alongside initiatives to increase disease awareness, improve early detection, and support patient access through co-pay assistance programs.
Epioxa is a non-invasive alternative to traditional corneal cross-linking, which typically requires removal of the corneal epithelium. The oxygen-enriched topical drug, bioactivated by UV light, is designed to eliminate procedure-related pain, streamline treatment, and shorten recovery while maintaining strong clinical efficacy.
Keratoconus affects mainly younger patients and can lead to visual impairment or blindness if untreated. Conventional treatments such as glasses or contact lenses address vision symptoms only, while traditional cross-linking procedures require epithelium removal, which can cause pain and long healing times. Epioxa uses two formulations — Epioxa HD and Epioxa — that are sequentially applied during the cross-linking procedure, followed by UV activation in an oxygen-enriched environment.
The FDA approval was based on two multicenter, randomized, double-masked Phase III pivotal trials involving more than 400 patients, both of which met their primary efficacy endpoints and demonstrated favorable safety and tolerability profiles.
“Epioxa is designed to significantly improve patient comfort and minimize recovery time, representing a game-changing new treatment for patients suffering from keratoconus.," said Glaukos Chairman and CEO Thomas Burns.
“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 procedures are major barriers to adoption," explained W. Barry Lee, 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.”
Glaukos plans to commercially launch Epioxa in the first quarter of 2026, alongside initiatives to increase disease awareness, improve early detection, and support patient access through co-pay assistance programs.
