Glaukos submits NDA to US FDA for Epioxa for the treatment of keratoconus

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Glaukos has announced the submission of its US FDA New Drug Application (NDA) for Epioxa, a next generation corneal cross linking iLink therapy for the treatment of keratoconus. The NDA submission includes data from 2 Phase 3 pivotal trials of Epioxa, both of which achieved their primary efficiency endpoints and demonstrated favorable tolerability and safety, according to a news release.

"The NDA submission for Epioxa represents an important milestone for our company as it brings us one step closer in being able to provide keratoconus patients and the ophthalmic community with the first FDA-approved, non-invasive corneal cross-linking drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye,” said Thomas Burns, Glaukos chairman and chief executive officer, in the release. “We look forward to working closely with the FDA in their pending review process and continue to believe Epioxa, which is designed to reduce procedure times, improve patient comfort and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus.”

Epioxa utilizes a proprietary, novel drug formulation which is designed to penetrate the epithelial layer of the cornea. This provides a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking. This design allows Epioxa to preserve the corneal epithelium, reduce procedure times, improve patient comfort, and shorten recovery time, according to the release

If approved, Glaukos states that it anticipates Epioxa as the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium.

Reference

1. Glaukos submits New Drug Application to US FDA for Epioxa. News release. Glaukos. December 23, 2024. Accessed December 23, 2024. https://www.businesswire.com/news/home/20241223560924/en/Glaukos-Submits-New-Drug-Application-to-U.S.-FDA-for-Epioxa%E2%84%A2