Epion Therapeutics Announces Full Enrollment in Apricity Phase 3 Trials for EpiSmart® Epithelium-On Corneal Cross-Linking
April 21, 2025
Burlington, MA – Epion Therapeutics, a clinical-stage ophthalmic biopharmaceutical company, announced today that it is completing enrollment in April in the Apricity Phase 3 clinical trials (NCT06100939 and NCT06100952) evaluating EpiSmart® Epithelium-On Corneal Cross-Linking in patients with keratoconus.
“We are grateful to the investigators, clinical sites, and especially the patients who made this milestone possible. If approved, by covering the full spectrum of disease from subclinical to advanced progressive keratoconus, EpiSmart would greatly expand access to vision-preserving treatment,” said Michael W. Belin, MD, Chief Medical Officer at Epion Therapeutics. “With enrollment complete, we look forward to collecting critical follow-up data and filing our NDA with the FDA for marketing authorization.”
The two identical, double-masked, sham-controlled trials were designed to evaluate the safety and efficacy of EpiSmart, recruiting up to 800 patients (400 per trial). Twenty-six U.S. clinics are participating in the trials and have enrolled patients with keratoconus ranging from early tomographic diagnosis to advanced progressive disease. Patients were randomly assigned to active investigational treatment or sham procedure in a 1:1 ratio with bilateral simultaneous treatments permitted when appropriate. The primary endpoint is based on visual acuity assessment at a 12-month follow-up visit.
Keratoconus is a progressive and often debilitating corneal disease that can lead to severe visual impairment and blindness. The EpiSmart Epithelium-On Corneal Cross-Linking system is a treatment for keratoconus designed to preserve the epithelium. Epion’s proprietary drug, RiboStat®, is formulated with sodium iodide to minimize the photodegradation of riboflavin and eliminate cytotoxic hydrogen peroxide byproducts, enhancing efficient oxygen-dependent cross-linking. EpiSmart requires no disruption of the epithelium and no oxygen supplementation.
Epion anticipates topline data readout in the first half of 2026.
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 on initial diagnosis 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