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# Reg Review Period for Spark’s Luxturna
- URL: https://www.fdaweb.com/reg-review-period-for-sparks-luxturna/
- Published: 2019-12-04T12:00:00.000Z
- Updated: 2026-09-14T15:55:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145645

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Spark Therapeutics Luxturna (voretigene neparvovec-rzyl), indicated for treating patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The review period is 3,809 days, which includes 3,591 days that occurred during the testing phase and 218 days during the approval phase. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-26252.pdf?ref=fdaweb.com).