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Spark Therapeutics' Vision Loss Gene Therapy Gets FDA Panel Review

Executive Summary

Voretigene neparvovec moves closer to being the first to market a gene therapy in the US with FDA advisory committee review on Oct. 12.

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Spark's Vision Loss Gene Therapy Raises US FDA Questions About Novel Endpoint

Multi-luminance mobility testing was developed by firm to measure functional vision across a range of lighting levels in patients with RPE65 mutations; advisory committee also will consider minimum patient age and clinical stage of disease appropriate for subretinal injections with voretigene.

Recent And Upcoming FDA Advisory Committee Meetings

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