Glaukos Corporation announced the United States Food and Drug Administration has approved Epioxa HD / Epioxa, a topical, incision-free therapy for keratoconus, according to a press release. The treatment strengthens the cornea without removing its outer layer, reducing pain and speeding recovery.
The approval follows two Phase 3 trials with over 400 patients, which showed the therapy to be safe and effective.
Epioxa will be commercially available in the first quarter of 2026, with Glaukos focusing on patient awareness, access programs, and earlier diagnosis of this underdiagnosed, sight-threatening disease.
“Keratoconus is currently an underdiagnosed and undertreated disease. 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 procedure are major barriers to adoption,” said W. Barry Lee, MD, 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.”
Read the full press release here.
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