November 10, 2026
Burlington, MA – Epion Therapeutics, Inc. (Epion), a clinical-stage biotechnology company developing EpiSmart® Epithelium-On Cross-Linking for the treatment of keratoconus, today announced the publication of the first peer-reviewed scientific article arising from its Phase 3 clinical program in Cornea. Conducted in collaboration with the Corneal Image Analysis Reading Center (CIARC) of the UH Eye Institute in Cleveland, Ohio, the study evaluated the impact of keratoconus disease severity on corneal endothelial cell density (ECD).
There is the potential for endothelial cell loss with increased UV exposure due to corneal thinning, chronic eye rubbing, and hypoxia from contact lens wear. Using specular microscopy and corneal tomography, researchers examined the correlation between central ECD and multiple measures of keratoconus severity, including corneal curvature, thickness, and elevation.
The study analyzed baseline data from 254 patients (477 eyes) enrolled at 11 clinical sites in Epion's Phase 3 program. The analysis demonstrated a statistically significant decline in ECD with increasing keratoconus severity and age. However, despite this decline, ECD remained within the physiological range in nearly all eyes, including those with advanced disease. Mean baseline ECD was 2,802 ± 285 cells/mm², with only one eye exhibiting a density below 2,000 cells/mm².
These findings contribute to the understanding of endothelial health across the spectrum of keratoconus severity and add to the growing body of scientific literature characterizing the disease. Epion thanks its collaborators at CIARC, clinical investigators, and study participants for their contributions to this research.
The publication, "A Multicenter, Randomized, Double-Masked, Sham-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-on Corneal Crosslinking in Keratoconus Subjects 8 to 45 Years of Age: Baseline Endothelial Studies” is available in Cornea and can be accessed through PubMed.
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