FDA Awards Fast Track Designation to Epion Therapeutics for its EpiSmart Epithelium-On Cross-Linking System
October 13, 2025
Burlington, MA – Epion Therapeutics today announced that the U.S. Food and Drug Administration (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. Fast Track is one of the Expedited Programs which “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.”
Fast Track designation is awarded when a product “is intended to treat a serious condition and nonclinical or clinical data demonstrate the potential to address unmet medical need” which “is not addressed adequately by available therapy.” Fast Track Designated products may be eligible for frequent interactions with FDA and rolling review. This designation may allow for accelerated approval and a priority review if all relevant criteria are met. This is a meaningful step forward in our ongoing effort to bring to market an accessible, minimally-invasive keratoconus treatment option for a wide spectrum of disease severity.
“We are very pleased with and appreciate that the FDA recognizes EpiSmart’s potential to advance the standard of care for patients living with keratoconus,” said Michael D. Webb, President and CEO of Epion Therapeutics. “This designation furthers our efforts to prevent vision loss for millions worldwide who are threatened with vision loss from keratoconus.”
About Epion Therapeutics:
Epion is conducting clinical trials to investigate EpiSmart, a minimally-invasive treatment for keratoconus that could bring early intervention to millions of patients globally. Our approach is a transformative cross-linking system designed for the bilateral treatment of keratoconus with neither disruption of the epithelium nor the need for documented disease progression. Prior studies have shown this approach may prevent vision loss and allow for a rapid recovery.
For more information, contact:
Epion Therapeutics
Email: info@epiontx.com
Website: www.epiontx.com