Glaukos Corp. announced the submission of its New Drug Application (NDA) to the 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 pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles, the company said in a press 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 company press release.
According to the company, Glaukos’ corneal cross-linking iLink therapies use proprietary, bio-activated drug formulations designed to strengthen corneal tissue and halt progression of keratoconus. While conventional keratoconus treatments such as eyeglasses or contact lenses address symptoms, Glaukos’ first-generation iLink therapy, known as Photrexa, or Epi-off, is the first and only FDA-approved therapy that has been shown to slow or halt disease progression, the company said in the press release. According to Glaukos, more than 300 peer-reviewed publications support the performance and safety of its iLink therapy.
Epioxa, which is designed to preserve the corneal epithelium, reduces procedure times, improves patient comfort and shortens recovery time, utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking. If approved, the company said it anticipates Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium.