US FDA awards Epion Therapeutics EpiSmart cross-linking system Fast Track designation

Epion Therapeutics announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to its EpiSmart epithelium-on (epi-on) cross-linking system. In a press release, Epion Therapeutics stated that the expedited program will accelerate development of its novel drug-device combination.

The EpiSmart system is designed for "the simultaneous bilateral treatment of keratoconus across a wide range of severity, including on diagnosis without documented progression,” according to the press release.¹ Fast Track designation is awarded to clinical interventions that are intended to treat serious pathologies with significant medical needs that are unmet by currently available therapies. Under this designation, the therapies may be eligible for rolling review, frequent interactions with the FDA, priority review procedures, and accelerated approval, if the company meets relevant FDA criteria.

“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,” Michael D. Webb, president and CEO of Epion Therapeutics, said in the press release.¹ “This designation furthers our efforts to prevent vision loss for millions worldwide who are threatened with vision loss from keratoconus.”

Epion Therapeutics described the EpiSmart epi-on cross-linking system as "a minimally-invasive treatment for keratoconus that could bring early intervention to millions of patients globally." Because the cross-linking process does not disrupt the epithelium, and does not require documentation of disease progression, it serves as a suitable intervention for patients with early-stage keratoconus. According to Epion Therapeutics, studies have demonstrated the early intervention can prevent loss of visual acuity, and may allow patients to recover more quickly.

In an interview with Sheryl Stevenson of Ophthalmology Times, Kenneth A. Beckman, MD, FACS, described the benefits of epi-on corneal crosslinking.² During the 2025 World Cornea Congress in Washington, DC, Dr. Beckman spoke about the unique approach used by Epion Therapeutics. Instead of utilizing supplemental oxygen, the approach used by Epion Therapuetics uses a chemical reaction to generate oxygen within the cornea. "Beckman explained that their proprietary riboflavin formulation includes an iodide molecule that converts toxic hydrogen peroxide byproducts into oxygen and water, enabling crosslinking without external oxygen supplementation," Stevenson reported in March.² In the interview, Dr. Beckman referenced Phase 2 data, which indicated over 80% of patients who underwent the EpiSmart form of epi-on crosslinking experienced stable or improved vision. In addition, 89% patients under the age of 21 experienced stable vision or improvement in vision.

References

1. FDA Awards Fast Track Designation to Epion Therapeutics for its EpiSmart Epithelium-On Cross-Linking System. Epion Therapeutics. Published October 13, 2025. Accessed October 13, 2025. https://www.epiontx.com/news/fda-awards-fast-track-designation-to-epion-therapeutics-for-its-epismart-epithelium-on-cross-linking-system

2. Stevenson S, Beckman K. World Cornea Congress IX: Epi-on and accelerated crosslinking with Kenneth Beckman, MD. Ophthalmology Times. Published March 27, 2025. Accessed October 13, 2025. https://www.ophthalmologytimes.com/view/world-cornea-congress-ix-epi-on-and-accelerated-crosslinking-with-kenneth-beckman-md