BioCentury
ARTICLE | Clinical News

FDA panel to discuss Spark's ophthalmic gene therapy

September 1, 2017 3:13 PM UTC

FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee will meet on Oct. 12 to discuss a BLA from Spark Therapeutics Inc.(NASDAQ:ONCE) for gene therapy Luxturna voretigene neparvovec (AAV2-hRPE65v2) to treat vision loss due to confirmed biallelic retinal pigment epithelium-specific protein 65kDa (RPE65)-mediated inherited retinal disease (IRD). The application is under Priority Review with a Jan. 12, 2018 PDUFA date...

Get Unlimited Access
Continue reading with a free trial.
Or Purchase This Article