Glaukos Corporation announced the US Food and Drug Administration (FDA) approved its Epioxa HD/Epioxa new drug application (NDA). Epioxa is an advancement in corneal cross-linking for the treatment of keratoconus. It offers an incision-free alternative to traditional corneal cross-linking procedures as it does not require the removal of the corneal epithelium, the company said in a press release.

This novel, oxygen-enriched topical therapeutic, bioactivated by UV light, is designed to eliminate the pain associated with removal of the epithelium, streamline the procedure, and minimize recovery. Epioxa is based on 2 formulations, Epioxa HD and Epioxa, that are sequentially administered during the cross-linking procedure followed by UV activation in an oxygen-enriched environment.

The FDA approval of Epioxa is based on results from 2 prospective, randomized, multicenter, double-masked, phase 3 pivotal trials that randomized a total of over 400 patients. Both trials successfully achieved their pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.

Glaukos said it intends for Epioxa to be commercially available in the first quarter of 2026. With this approval, Glaukos said it plans to make substantial investments in patient awareness and access while addressing the longstanding challenges of underdiagnosis and undertreatment that have affected this rare disease patient community. These efforts will focus on supporting patients and families across every step of the journey, from awareness to diagnosis and treatment. Key initiatives include streamlined patient access support programs, a co-pay assistance program to reduce financial barriers, integrated healthcare professional (HCP) and patient-centric strategies to improve education and engagement, and broad awareness and detection programs aimed at earlier and more widespread screening for and diagnosis of the disease.