The FDA granted orphan drug designation for Cellusion’s CLS001, a corneal endothelial cell substitute for bullous keratopathy, according to a press release.
CLS001 combines “CECSi cells” made from iPS cells and a simple injection delivery procedure. The cell therapy may help meet global transplant needs for bullous keratopathy, a condition responsible for more than half of all corneal transplants, according to the release.
Cellusion plans to begin corporate clinical trials in Japan as well as global clinical trials for the therapy.
“With this designation, we will further