FDA Grants Orphan Drug Designation to Cellusion's CLS00 for Bullous Keratopathy

Cellusion announced that its regenerative medicine product, known as "iPS cell-derived corneal endothelial cell substitute" (CLS001), has received orphan drug designation from the FDA for bullous keratopathy.

The FDA grants orphan drug designation upon drugs that meet specific criteria for treating, diagnosing, or preventing rare diseases affecting fewer than 200,000 individuals in the United States. This designation provides sponsors with various incentives, such as tax credits for qualified clinical testing in humans, a waiver of the prescription drug user fee, and the potential for 7 years of market exclusivity post-FDA approval.

CLS001, created by Cellusion to address bullous keratopathy, a condition responsible for over 50% of corneal transplants, is presently undergoing preparations for corporate clinical trials in Japan and global clinical trials. With the conferred designation, the company has affirmed its commitment to expedite the worldwide development of CLS001, with the overarching goal of providing relief to patients worldwide eagerly anticipating effective treatment options.

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