US FDA Grants RMAT Status to Emmecell’s Corneal Cell Therapy Candidate — Emmecell’s proposed corneal edema treatment consists of an injection of EO2002 and a few hours of wearing a magnetic patch, intended to draw the therapeutic cells to the target location.

Emmecell announced July 7 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to EO2002, the company’s corneal endothelial cell therapy candidate.

The RMAT designation, established under the 21st Century Cures Act, allows companies developing regenerative medicine and gene therapies to work more closely and frequently with the FDA, and grants all the benefits of breakthrough therapy designation, including eligibility for priority review, rolling review, and accelerated approval.

Emmecell, of Menlo Park, California, says its Magnetic Cell Delivery nanoparticle platform for corneal edema mixes healthy endothelial cells obtained from donor corneas with biocompatible magnetic nanoparticles.

EO2002 is delivered by intracameral injection. An external magnetic patch worn for a few hours over a closed eyelid is intended to draw the therapeutic cells to the target location in the cornea. The treatment candidate is in Phase I/II study.

Emmecell’s pipeline also includes preclinical candidates for glaucoma and macular degeneration.

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