US FDA Accepts NDA for Glaukos’ Epioxa, Sets PDUFA Date of Oct. 20, 2025

Glaukos, of Aliso Viejo, California, reported Feb. 24 that the US FDA had accepted its new drug application for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy, for the treatment of keratoconus.

The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of Oct. 20, 2025.

Epioxa is designed to reduce the treatment’s procedure and recovery time and improve patient comfort.

Glaukos’ first-generation iLink procedure takes roughly an hour and requires the removal of the corneal epithelium, the outermost layer of the front of the eye—a process that can be painful for patients. It uses the riboflavin solutions Photrexa and Photrexa Viscous (also containing dextran) combined with UV light to strengthen chemical bonds in the cornea with the goal of stiffening structurally weak and unstable tissue.

Epioxa is formulated to allow the riboflavin to penetrate the epithelial layer of the cornea, eliminating the need to remove it. In addition, Epioxa employs a stronger UV-A irradiation protocol and supplemental oxygen to enhance crosslinking.

Corneal health accounted for $80.2 million of Glaukos’ $383.5 million in revenue in 2024, including $68.6 million in Photrexa sales.