Glaukos Says FDA Accepts Epioxa NDA Submission For Treatment Of Keratoconus

(RTTNews) - Glaukos Corp. (GKOS), an ophthalmic pharmaceutical and medical technology company, announced Monday it has 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) is sufficiently complete to permit a substantive review.

The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review of the Epioxa NDA is set for October 20, 2025. This date reflects a standard 10-month review period, which is consistent with the company's expectations.

Epioxa is a next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a sight-threatening corneal disease. This therapy uses proprietary, bio-activated drug formulations designed to strengthen corneal tissue and halt progression 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.

If approved, the company anticipates Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye.