iRegene’s NouvSight001 Gains Orphan Drug Designation for Retinitis Pigmentosa Treatment

Wuhan-based cell therapy innovator iRegene has secured Orphan Drug Designation (ODD) from the U.S. FDA for its ophthalmic product NouvSight001, aimed at treating retinitis pigmentosa (RP).

NouvSight001 is heralded as the world’s first universal ophthalmic cell therapy derived from induced pluripotent stem cells (iPSCs), developed through an innovative “AI+chemical induction” platform. This breakthrough therapy represents a significant advancement in ophthalmic treatment options.

Retinitis pigmentosa, a hereditary eye disorder, can lead to progressive vision loss and ultimately blindness, characterized by symptoms such as night blindness and narrowing visual fields. With over 50 genetic variations contributing to its onset, RP results primarily from the degeneration of retinal rod and cone cells. Currently, there are no effective clinical treatments available for this debilitating condition.- Flcube.com

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