Epion Therapeutics Initiates Phase 3 Clinical Trials for Minimally-Invasive Keratoconus Treatment
Burlington, MA – October 31, 2023 – Epion Therapeutics (Epion) announced the commencement of its Phase 3 Apricity trials for EpiSmart™, the company’s minimally-invasive keratoconus therapy. This marks a milestone in the company's mission to redefine the treatment of keratoconus. EpiSmart is an investigational drug-device combination indicated for epithelium-on cross-linking to treat keratoconus upon initial diagnosis.
Keratoconus is a bilateral progressive corneal disorder which causes permanent vision loss and affects an estimated 3 million patients in the United States, with greater prevalence in Africa and the Middle East indicated in recent publications.
The randomized, masked, placebo-controlled Apricity trials will evaluate the safety and efficacy of EpiSmart, building upon the promising results observed in Phase 2 clinical trials. Epion plans to enroll 800 subjects at over 20 investigational sites throughout the US in two concurrent Apricity Phase 3 trials. Patients as young as 8 years of age meeting entrance criteria may be enrolled. Patients will receive bilateral, simultaneous treatment when indicated.
“Epion’s goal is to provide a pioneering treatment that offers a brighter future for millions of keratoconus patients,” says Michael W. Belin MD, Chief Medical Officer of Epion.
EpiSmart is designed to offer patients significant advantages over the currently approved epithelium-off cross-linking therapy. Epithelium-off cross-linking is invasive, requiring surgical removal of the corneal epithelium, and is associated with pain and lengthy rehabilitation. Comparatively, EpiSmart is minimally invasive without the need for chemical or mechanical disruption of the epithelium, enabling a rapid return to daily activities. The currently approved epithelium-off therapy requires documented disease progression, delaying treatment and often causing a permanent loss of visual function. EpiSmart is being developed to treat keratoconus upon diagnosis, interrupting the disease process earlier and preserving or improving vision.
Patients in the Phase 2 trials of EpiSmart received simultaneous, bilateral treatment and experienced a very low rate of adverse events. Bilateral treatment represents a significant advantage and convenience to patients.
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 chemical or mechanical disruption of the epithelium, allowing for a rapid return to normal activities.
For more information, please visit epiontx.com.