Glaukos submits new drug application for corneal cross-linking therapy

Glaukos submitted a new drug application to the FDA for Epioxa, an epithelium-on corneal cross-linking iLink therapy for the treatment of keratoconus, according to a company press release.

Epioxa is designed to enhance cross-linking by preserving the corneal epithelium, improving patient comfort and reducing both procedure and recovery time with its drug formulation that allows for penetration of the epithelial layer of the cornea, a stronger UV-A irradiation protocol and supplemental oxygen. The NDA is supported by data from two phase 3 trials, both of which demonstrated positive safety and tolerability profiles for Epioxa.

“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, noninvasive corneal cross-linking drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye,” Thomas Burns, chairman and CEO of Glaukos, said in the release.

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