Epion Therapeutics commences phase 3 clinical trials for EpiSmart keratoconus treatment
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Epion Therapeutics has initiated its phase 3 Apricity trials for EpiSmart, a minimally invasive drug-device combination indicated for epithelium-on cross-linking in the treatment of keratoconus.
“Epion’s goal is to provide a pioneering treatment that offers a brighter future for millions of keratoconus patients,” Michael W. Belin, MD, Epion’s chief medical officer, said in a company press release.
The Apricity trials are randomized and placebo-controlled to evaluate the safety and efficacy of EpiSmart. The company aims to enroll 800 participants, as young as 8 years, across 20 investigational sites in the U.S.
According to the release, EpiSmart is designed to eliminate the need for chemical or mechanical disruption of the epithelium, minimizing pain and recovery time, to treat keratoconus upon diagnosis.
Participants in previous phase 2 trials of EpiSmart received simultaneous, bilateral treatment and had low rates of adverse events, the release stated.
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