Voretigene Neparvovec

Form: Subretinal injection

Strength: Adeno-associated virus (AAV) vector administered via subretinal injection

Reference Brands: Luxturna(US & EU)

Category: Cell & Gene Therapies

Voretigene neparvovec (Luxturna) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality per GMP standards. In the US, FDA approval involved comprehensive clinical trials and validation. In the EU, CE marking certifies conformity with MDR standards for gene therapy applications. These products undergo validation, stability testing, and audits, with detailed documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective gene therapy for inherited retinal diseases, supporting improved vision outcomes and quality of life globally.