Luxturna (voretigene neparvovec) · Spark Therapeutics, Inc.
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). Patients must have viable retinal cells as determined by the treating physician(s).
Details
- Status
- Prescription
- First Approved
- 2017-12-18
- Patent Cliff
- 2024
- Routes
- Intraocular
- Dosage Forms
- Injection
Luxturna Approval History
What Luxturna Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 2017)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Luxturna FDA Label Details
Indications & 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).
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.