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# Spark Rolling BLA for Retinal Disease
- URL: https://www.fdaweb.com/spark-rolling-bla-for-retinal-disease/
- Published: 2017-05-18T12:00:00.000Z
- Updated: 2026-09-14T22:24:26.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138729

Spark Therapeutics has completed a rolling BLA submission for voretigene neparvovec, an investigational, one-time gene therapy for treating patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal disease. The filing includes data from three clinical trials that enrolled 41 participants with the retinal disease, including the first randomized, controlled Phase 3 trial for a gene therapy for a genetic disease, according to the company. FDA will have 60 days to review the submission to determine if it is complete and reviewable.