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October 20, 2025
1 min read
Key takeaways:
- Epioxa is the first epithelium-on cross-linking procedure approved in the U.S.
- Glaukos plans for Epioxa to be commercially available in early 2026.
The FDA approved Epioxa for the treatment of keratoconus, Glaukos announced in a press release.
“We’re proud to announce an extraordinary milestone for keratoconus patients with the approval of Epioxa,” Thomas Burns, Glaukos chairman and CEO, told Healio. “Epioxa is the result of years of dedicated innovation, research and determination to set a new standard in keratoconus care. As the first and only FDA-approved incision-free procedure using bioactive topical drops for keratoconus, this approval underscores our unwavering commitment to addressing critical unmet needs in ophthalmology.”
The corneal epithelium is not removed in Epioxa, offering an incision-free cross-linking treatment.
The approval is based on the results of two phase 3 pivotal trials of more than 400 patients. Both trials achieved efficacy endpoints and demonstrated tolerability and safety.
Glaukos plans for Epioxa to be commercially available in the first quarter of 2026, according to the release.
“With this groundbreaking treatment, we are seeking to deliver more than science — we are seeking to deliver hope, improved quality of life and a brighter future for our patients,” Burns told Healio. “We look forward to working closely with physicians and the broader eye care community to ensure patients have access to this transformative therapy as quickly as possible.”
Perspective
The FDA approval of the Glaukos Epioxa epithelium-on corneal cross-linking treatment for progressive keratoconus is a significant advance in the treatment of this rare disease.
Because epithelium removal is no longer required in the Glaukos Epioxa cross-linking procedure, the patient with keratoconus and treating surgeon now have an effective treatment with reduced pain, more rapid visual recovery, and a lower risk for complications such as corneal haze and infection.
All patients with progressive keratoconus should be treated as early as possible to arrest progression of this sight-threatening disease, allowing decades of better visual function, enhanced quality of life and a reduced chance that a corneal transplant will ever be needed.
Richard L. Lindstrom, MD
Disclosures: Lindstrom reports consulting for Glaukos.
Sources/Disclosures
Source:
Disclosures:
Burns reports being chairman and CEO of Glaukos.
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