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# Priority Review for Spark Gene Therapy BLA
- URL: https://www.fdaweb.com/priority-review-for-spark-gene-therapy-bla/
- Published: 2017-07-17T12:00:00.000Z
- Updated: 2026-09-14T22:34:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139151

FDA has accepted for priority review a Spark Therapeutics BLA for Luxturna (voretigene neparvovec), a investigational gene therapy for treating patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease. The agency has set a 1/12/2018 user fee review target date.

The submission is based on Phase 3 data that “showed a statistically significant and clinically meaningful difference between intervention (n=21) and control participants (n=10) at one year, per the clinical trial’s primary endpoint, mean bilateral multi-luminance mobility testing change score,” the company says. “In addition, participants who received Luxturna showed a marked difference compared to control participants across the first two secondary endpoints: full-field light sensitivity threshold testing and the mobility test change score for the first injected eye.”

  
Spark notes that no serious adverse events associated with the therapy or deleterious immune responses were observed. There were three non-serious AEs of retinal deposit (subretinal precipitate) in three participants that were considered to be related to the therapy, it adds.