Glaukos Corporation announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus. The NDA submission includes data from two Phase 3 pivotal trials of Epioxa, which both successfully achieved the prespecified 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 progression of keratoconus. According to the company, Epioxa, which is designed to preserve the corneal epithelium, reduce procedure times, improve patient comfort, and shorten recovery time, utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UVA irradiation protocol and supplemental oxygen to enhance cross-linking. If approved, the company anticipates Epioxa would be the first FDA-approved, noninvasive corneal cross-linking therapy that does not require removal of the corneal epithelium.