LUXTURNA — FDA product page
Source: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/luxturna · Published: accessed 2026-10-11 · Language: English
Note: captured from the FDA Cellular & Gene Therapy Products page for LUXTURNA; navigation, feedback widgets and boilerplate stripped.
STN: 125610
Proper name: voretigene neparvovec-rzyl
Trade name: LUXTURNA
Manufacturer: Spark Therapeutics, Inc.
Indication
- For the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Product Information
- Package Insert - LUXTURNA (fda.gov/media/109906)
- Demographic Subgroup Information - voretigene neparvovec [LUXTURNA] (Clinical Review, December 16, 2017)
Supporting Documents
- June 8, 2022 Approval Letter - LUXTURNA
- December 19, 2017 Approval Letter - LUXTURNA
- December 18, 2017 Summary Basis for Regulatory Action - LUXTURNA
- Approval History, Letters, Reviews, and Related Documents - LUXTURNA
Related Information
- FDA news release: “FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss” (December 19, 2017).