Glaukos’ Epioxa eyes FDA approval as the first non-invasive cross-linking therapy for keratoconus.
Glaukos Corporation (California, USA) announced yesterday that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Epioxa (Epi-on), a next-generation corneal cross-linking therapy for keratoconus. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 20, 2025, marking the anticipated completion of its review.
“The acceptance of the Epioxa NDA represents another important step in being able to provide keratoconus patients and the ophthalmic community with the first FDA-approved, non-invasive corneal cross-linking drug therapy that does not require the removal of the corneal epithelium, the outermost layer of the front of the eye,” said Thomas Burns, Glaukos chairman and chief executive officer, in a news release.
“We look forward to working closely with the FDA throughout their review process and continue to believe Epioxa, which is designed to reduce procedure times, improve patient comfort and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus,” he added.
Epioxa crosslinking data
The NDA submission includes data from two Phase III pivotal trials, both of which met their prespecified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.
In the confirmatory Phase III trial, Epioxa demonstrated a corneal curvature (Kmax) treatment effect of -1.0 diopter (p <0.0001) at the 12-month endpoint, measured as least square mean Kmax change from baseline compared to the placebo-controlled arm. Additionally, no patients in the Epioxa group discontinued early due to adverse events, and no ocular serious adverse events were reported.
Currently, Glaukos’ iLink therapy (Photrexa, or Epi-off), with a proprietary, bio-activated drug formulation designed to strengthen corneal tissue, is the only FDA-approved treatment shown to slow or halt disease progression.
What is Epioxa?
Epioxa utilizes a novel drug formulation designed to penetrate the corneal epithelium, combined with a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking. If approved, Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy available to patients.
Glaukos is a pharmaceutical and medical technology company focused on glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery (MIGS) and launched its first MIGS device in 2012. In 2024, Glaukos also commenced the commercial launch of iDose TR, a long-duration, intracameral pharmaceutical for glaucoma treatment.
