Epion Therapeutics Completes Phase 3 Clinical Program for EpiSmart® Epithelium-On Corneal Cross-Linking
June 12, 2026
Burlington, MA – Epion Therapeutics, Inc. (Epion) today announced that the final patient has completed the last study visit in the company's Phase 3 trials evaluating EpiSmart®, an investigational epithelium-on corneal cross-linking procedure for the treatment of keratoconus. The completion of all follow-up exams across both pivotal studies marks a significant milestone for Epion as it advances toward regulatory submission to the U.S. Food and Drug Administration (FDA).
The Phase 3 clinical program consists of two identical, double-masked, sham-controlled trials evaluating the safety and efficacy of EpiSmart. Initiated in October 2023, the studies enrolled approximately 800 patients across 26 U.S. clinical sites, including patients with disease ranging from early tomographic diagnosis to advanced progressive keratoconus. Participants were randomized 1:1 to receive EpiSmart or a sham procedure, with simultaneous bilateral treatment performed when appropriate. Both studies were designed with Best Spectacle-Corrected Distance Visual Acuity (BSCDVA) at 12 months as the primary endpoint, reflecting a focus on functional vision outcomes.
“We are deeply grateful to every patient who participated in our clinical trials and to the investigators and study personnel whose commitment made this milestone possible,” said Michael W. Belin, Chief Medical Officer of Epion Therapeutics. “We look forward to sharing the results of the program following data analysis.”
“We believe EpiSmart represents the next step in the evolution of cross-linking,” said Michael D. Webb, President & CEO of Epion. “The completion of our Phase 3 program brings us one step closer to making EpiSmart available to keratoconus patients and all who care for them.”
Subject to the outcome of the studies and regulatory review, Epion plans to submit an NDA to the U.S. FDA seeking approval of EpiSmart in the United States. In October 2025, the FDA granted Fast Track designation to EpiSmart for the treatment of keratoconus. Fast Track designation is intended to facilitate the development and expedite the review of therapies for serious conditions with unmet medical needs.
About EpiSmart Epithelium-On Cross-Linking System:
EpiSmart is a minimally invasive corneal cross-linking system designed to strengthen the cornea while preserving the epithelium. EpiSmart combines a proprietary wand designed to cleanse the ocular surface without epithelial disruption, a loading sponge engineered to support uniform stromal drug distribution, and a fixed-dose riboflavin and iodide formulation intended to optimize cross-linking efficiency without the need for supplemental oxygen. The UV-A light is delivered through the first and only bilateral treatment device incorporating a proprietary light cycling protocol designed to support oxygen re-diffusion during treatment.
About Epion Therapeutics:
Epion is developing EpiSmart, a minimally invasive treatment for keratoconus and ectatic corneal disease that could bring early intervention to millions of patients globally. Our approach is a transformative cross-linking system designed to treat keratoconus without disruption of the epithelium, allowing for a rapid return to normal activities.
For more information, contact:
Epion Therapeutics
Email: info@epiontx.com
Website: www.epiontx.com