Posted by Michael Wonder on 13 Oct 2025
FDA awards fast track designation to Epion Therapeutics for its EpiSmart epithelium on cross linking system
13 October 2025 - Epion Therapeutics today announced that the US FDA 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.
