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Spark Restores Vision In Phase III; CEO Hopes To Lead Gene Therapy Field

 
• By Mandy Jackson

Spark Therapeutics is preparing to seek the first-ever US FDA approval for a gene therapy after several people who couldn't read a menu in a dimly lit restaurant or take a walk alone at dusk had their vision restored in a Phase III clinical trial testing SPK-RPE65.

Spark Therapeutics is preparing to seek the first-ever US FDA approval for a gene therapy after several people who couldn't read a menu in a dimly lit restaurant or take a walk alone at dusk had their vision restored in a Phase III clinical trial testing SPK-RPE65.

Two-thirds of the 21 people with RPE65-mediated inherited retinal dystrophies (IRDs) who were treated with SPK-RPE65 in a 31-patient Phase III trial derived the maximum possible benefit that could be measured by the study's primary visual function test – navigation of a mobility course under lighting levels ranging from a moonless summer night (one lux) to a brightly lit office (400 lux)

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