HQ Team
October 21, 2025: The Food and Drug Administration has approved Glaukos Corporation’s drug to treat keratoconus, a rare, sight-threatening eye disease that is currently far too often undiagnosed and untreated.
Drug Epioxa offers an incision-free alternative to traditional corneal cross-linking procedures, as it does not require the removal of the corneal epithelium, the outermost layer of the front of the eye, according to a company statement.
The drug, a topical therapeutic, is designed to be bioactivated by ultraviolet light when applied, eliminating the pain associated with epithelium removal, streamlining the procedure, and minimising recovery.
The US regulator’s approval was based on results from two end-stage studies involving more than 400 patients. “Both trials successfully achieved their pre-specified primary efficacy endpoints and demonstrated favourable tolerability and safety profiles.”
Available in early 2026
Glaukos plans to make the drug commercially available in the first quarter of 2026.
Keratoconus is a debilitating eye condition characterised by progressive thinning and weakening of the cornea and often aggressively advances in patients under the age of 30.
If left untreated, keratoconus can lead to loss of visual function and even blindness and is one of the leading causes of corneal transplants (penetrating keratoplasty) in the US. About 90% of cases of keratoconus are bilateral, and as many as 20% of untreated keratoconus patients ultimately require a corneal transplant.
Conventional keratoconus treatments, such as eyeglasses or contact lenses, address visual symptoms only and do not slow or halt underlying disease progression.
‘Pain, healing time’
“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 minimise recovery time, representing a game-changing new treatment for patients suffering from keratoconus.
The pain and extended healing time associated with the current surgical procedure were 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.”
Glaukos is headquartered in Aliso Viejo, California, and has locations in Canada, the United Kingdom, Germany, Japan, Australia and Brazil.
