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Spark's Gene Therapy Luxturna Sails Through US FDA Panel

 
• By Sue Sutter

Improvements seen in multi-luminance mobility testing in the voretigene Phase III trial were clinically meaningful, panelists said, endorsing the novel endpoint for the vision loss treatment. They also were persuaded by first-hand accounts from patients.

Blind pedestrian walking and detecting markings on tactile paving with textured ground surface indicators for blind and visually impaired.

A US FDA advisory committee's strong backing of Spark Therapeutics Inc.'s Luxturna (voretigene neparvovec) for inherited retinal dystrophy at an Oct. 12 meeting came with an endorsement of the sponsor's novel endpoint for assessing the gene therapy's impact on functional vision.

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