Epioxa FDA Approval Status

Last updated by Judith Stewart, BPharm on Feb 3, 2025.

FDA Approved: No
Brand name: Epioxa
Company: Glaukos Corporation
Treatment for: Keratoconus

Epioxa is a next-generation corneal cross-linking iLink therapy for the treatment of keratoconus.

Keratoconus is debilitating and sight-threatening eye condition characterized by progressive thinning and weakening of the cornea.
Epioxa is a non-invasive, corneal cross-linking drug therapy designed to strengthen corneal tissue and halt the progression of keratoconus. Epioxa is designed to penetrate the epithelial layer of the cornea and does not require removal of the corneal epithelium, the outermost layer of the front of the eye.
A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for Epioxa for the treatment of keratoconus. The NDA submission includes data from two Phase 3 pivotal trials of Epioxa, which both successfully achieved the pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.

Development timeline for Epioxa

Date	Article
Dec 23, 2024	Glaukos Submits New Drug Application to U.S. FDA for Epioxa
Oct 16, 2024	Glaukos Announces Positive Topline Outcomes in Phase 3 Confirmatory Trial for Epioxa, Achieving Primary Efficacy Endpoint and Demonstrating Favorable Tolerability and Safety

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