TheraRadar
Data updated: Nov 8, 2026

Luxturna (voretigene neparvovec) · Spark Therapeutics, Inc.

Approved 2017-12-19
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-12-19
Patent Cliff
2024
Revenue
$5M (Q3-2026) US sales (Roche); converted from CHF 4m

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
Intraocular
Dosage Forms
Injection

Companies

Spark Therapeutics, Inc.
Active Ingredient: Voretigene Neparvovec

Luxturna Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2017 to 2017
Dec 2017 ORIGINAL
Update · CBER biologic (Purple Book)

What Luxturna Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

Pro Intelligence Preview

Deep insights for Luxturna

Revenue Insights

  • • Q3-2026: $5M (US sales (Roche); converted from CHF 4m)
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2024
  • • Generic/biosimilar risk

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: BLA125610 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.