Epion Therapeutics’ EpiSmart Cross-Linking System Granted FDA Fast Track Designation

Epion Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its EpiSmart epithelium-on (epi-on) cross-linking system, a novel drug-device combination developed for the treatment of keratoconus. This regulatory milestone is expected to significantly accelerate the clinical development and review process of the EpiSmart platform.

Advancing Keratoconus Treatment Through Early Intervention

According to Epion Therapeutics, the EpiSmart system is designed for simultaneous bilateral treatment of keratoconus across a broad spectrum of disease severity, including patients diagnosed with keratoconus without documented disease progression. This capability represents a meaningful step toward early intervention, aiming to preserve visual acuity before irreversible damage occurs.

Unlike traditional epithelium-off cross-linking, the EpiSmart system offers a minimally invasive, epithelium-on (epi-on) procedure, which allows treatment without removing the corneal epithelium. This approach may reduce recovery time and improve patient comfort, making it a potential early-stage option for millions of individuals globally affected by keratoconus.

Benefits of the FDA Fast Track Designation

The Fast Track designation is reserved for investigational therapies intended to treat serious or life-threatening conditions with unmet medical needs. With this designation, Epion Therapeutics will have enhanced access to the FDA through frequent communication, rolling submission of regulatory documents, eligibility for priority review, and potential accelerated approval, provided certain criteria are met.

CEO Statement on Regulatory Recognition

Michael D. Webb, President and CEO of Epion Therapeutics, expressed optimism about the designation:

“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. This designation furthers our efforts to prevent vision loss for millions worldwide who are threatened with vision loss from keratoconus.”