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. EpiSmart’s true epithelium-on approach – without chemical or physical disruption of the epithelium – is designed to reduce patient discomfort and significantly reduce recovery time versus current standards of care. Unlike current treatments for keratoconus, EpiSmart is designed to be implemented as early as initial diagnosis and on both eyes simultaneously.
Results of Epion’s recent Phase 2 trial, the largest study to-date of corneal cross-linking as a treatment for keratoconus, indicate improvements in visual acuity after EpiSmart treatment at levels similar to currently available treatments. Of the 784 patients with keratoconus who were followed for 12 months, over 80% had stable or improved vision following EpiSmart treatment.
Epion initiated Phase 3 clinical trials for the treatment of keratoconus with EpiSmart in Q4 2023. Funded by the AXA IM Global Health Fund and over 50 cornea specialists, Epion expects to read out its Phase 3 trial for FDA submission in early 2026.