Epion Therapeutics, Inc announced the final patient has completed the last study visit in the company's phase 3 trials evaluating EpiSmart, an investigational epithelium-on corneal cross-linking procedure for the treatment of keratoconus. The completion of all follow-up exams across both pivotal studies, will allow Epion to advance toward regulatory submission to the US Food and Drug Administration (FDA), the company said in a press release. 

EpiSmart is a minimally invasive corneal cross-linking system designed to strengthen the cornea while preserving the epithelium. It combines a proprietary wand designed to cleanse the ocular surface without epithelial disruption, a loading sponge engineered to support uniform stromal drug distribution, and a fixed-dose riboflavin and iodide formulation intended to optimize cross-linking efficiency without the need for supplemental oxygen. The UV-A light is delivered through a bilateral treatment device incorporating a proprietary light cycling protocol designed to support oxygen re-diffusion during treatment.

The phase 3 clinical program consists of 2 identical, double-masked, sham-controlled trials evaluating the safety and efficacy of EpiSmart. Initiated in October 2023, the studies enrolled approximately 800 patients across 26 US clinical sites, including patients with disease ranging from early tomographic diagnosis to advanced progressive keratoconus. Participants were randomized 1:1 to receive EpiSmart or a sham procedure, with simultaneous bilateral treatment performed when appropriate. Both studies were designed with best spectacle-corrected distance visual acuity at 12 months as the primary endpoint, reflecting a focus on functional vision outcomes.

Subject to the outcome of the studies and regulatory review, Epion said it plans to submit a new drug application to the FDA seeking approval of EpiSmart in the United States. In October 2025, the FDA granted Fast Track designation to EpiSmart for the treatment of keratoconus. OM