FDA grants orphan drug designation for bullous keratopathy cell therapy
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Key takeaways:
- The FDA has granted orphan drug designation for Cellusion’s CLS001 cell therapy.
- CLS001 is a corneal endothelial cell substitute used to treat bullous keratopathy.
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 accelerate the global development of CLS001 and aim to contribute to patients around the world who are waiting for the treatment,” the company wrote in the release.
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