Glaukos Corporation announced the submission of its New Drug Application (NDA) to the FDA for its epithelial-on corneal cross-linking iLink therapy Epioxa for Keratoconus.
The NDA submission includes data from two phase 3 trials of Epioxa, which both achieved pre-specified primary efficacy endpoints and demonstrated favourable tolerability and safety profiles, according to a press release.
Currently only epithelium-off corneal crosslinking is approved for the treatment of progressive Keratoconus.
Epioxa would increase patient comfort, lessen recovery time, and optimise procedure safety when it is approved!