FDA Sets Decision Date For Glaukos' Keratoconus Treatment Without The Need Of Surgery

On Monday, Glaukos Corporation GKOS received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug Application (NDA) for Epioxa (Epi-on), its next-gen corneal cross-linking iLink therapy for keratoconus, a sight-threatening corneal disease, is sufficiently complete to permit a substantive review.

The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of the Epioxa NDA is set for Oct. 20, 2025.

Also Read: Glaukos Delivers Mixed Q4 Results, Analyst Sees Growing Investor Interest During Transition

“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 removal of the corneal epithelium, the outermost layer of the front of the eye,” said Glaukos CEO Thomas Burns.

The NDA submission includes data from two Phase 3 pivotal Epioxa trials, which achieved the pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.

Glaukos’ corneal cross-linking iLink therapies use proprietary, bio-activated drug formulations designed to strengthen corneal tissue and halt the progression of keratoconus.

Glaukos’ first-generation iLink therapy, known as Photrexa, or Epi-off, is the first and only FDA-approved therapy that has been shown to slow or halt disease progression.

Epioxa utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UV-A irradiation protocol, and supplemental oxygen to enhance cross-linking.

Price Action: GKOS stock is up 25% at $157.36 during the premarket session on last check Monday.

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