Epion Therapeutics announced the US Food and Drug Administration (FDA) has granted fast track designation for EpiSmart Epithelium-On Cross-Linking System, the company’s novel drug-device combination.

EpiSmart is designed for the simultaneous bilateral treatment of keratoconus across a wide range of severity, including on diagnosis without documented progression, the company said in a press release.

The company said this is a meaningful step forward in its ongoing effort to bring to market an accessible, minimally-invasive keratoconus treatment option for a wide spectrum of disease severity. 

Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.