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PlainMeds

Prescription medicine

Voretigene neparvovec-rzyl Brand names: Luxturna

Voretigene neparvovec-rzyl (Luxturna) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the voretigene neparvovec-rzyl FDA label on DailyMed (effective May 1, 2022); every voretigene neparvovec-rzyl label on DailyMed.

Highlights of the record

FDA label of May 1, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

Forms and strengths

Kit.

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
152 through July 30, 2026

What is voretigene neparvovec-rzyl used for?

From the label: indications and usage

LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s). LUXTURNA is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s).

Source: FDA drug label (LUXTURNA), Spark Therapeutics, Inc., effective May 1, 2022 (SPL set 08313a24-e7ce-457a-bb3f-161bc45517ee), via openFDA; the full label on DailyMed

Is there a generic for voretigene neparvovec-rzyl (Luxturna)?

No generic voretigene neparvovec-rzyl is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for voretigene neparvovec-rzyl?

The FDA Adverse Event Reporting System holds 152 reports that list voretigene neparvovec-rzyl among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 15 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Intraocular Pressure Increased (named in the label)22
  • Retinal Degeneration (named in the label)15
  • Eye Pain (named in the label)12
  • Visual Impairment12
  • Cataract (named in the label)8
  • Chorioretinal Atrophy (named in the label)8
  • Retinal Depigmentation (named in the label)8
  • Retinal Tear (named in the label)8

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Voretigene neparvovec-rzyl side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other