An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Cellular & Gene Therapy Products

LUXTURNA

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
Demographic Subgroup Information - voretigene neparvovec [LUXTURNA]
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

Related Information

FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss

Top