FDA accepts IND application for EO2002 to treat corneal edema
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The FDA has accepted an investigational new drug application for EO2002, Emmecell’s lead candidate for the treatment of corneal edema, according to a press release.
The designation allows the company to begin a phase 1 clinical trial for the first-in-class, nonsurgical, magnetic cell-based therapy, which may modify the disease and potentially prevent or delay more serious procedures such as corneal transplantation. The trial will assess tolerability, safety and efficacy of the treatment.
“The FDA’s acceptance of our IND is an important validation of our novel magnetic cell delivery platform and marks a significant milestone for Emmecell as our lead product candidate, EO2002, advances into the clinic,” Jeffrey L. Goldberg, MD, PhD, co-founder of Emmecell, said in the release. “In initial preclinical and early-phase human testing, EO2002 has demonstrated a strong safety and efficacy profile.”
Patient enrollment for the trial is expected to begin in the first quarter of 2021.
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