Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceuticals and medical technology company, announced on Monday that the U.S. 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 Prescription Drug User Fee Act (PDUFA) target date for FDA review completion is 20 October 2025, aligning with the standard 10-month review period.

The submission includes data from two Phase 3 trials that met primary efficacy endpoints and demonstrated favorable safety and tolerability. Epioxa is designed to penetrate the corneal epithelial layer without requiring its removal, using an advanced UV-A irradiation protocol and supplemental oxygen to enhance cross-linking. If approved, it would be the first FDA-approved non-invasive corneal cross-linking therapy.

Keratoconus, a progressive corneal disease, is a leading cause of corneal transplants in the US and can lead to severe vision loss if untreated. Glaukos' first-generation iLink therapy, Photrexa (Epi-off), is currently the only FDA-approved treatment shown to slow disease progression.

Glaukos pioneered Micro-Invasive Glaucoma Surgery (MIGS) and launched iDose TR in 2024, an extended-release intracameral glaucoma therapy. The company continues to advance a pipeline of innovative, dropless treatments for chronic eye diseases.