Prescribing information

 

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Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.1

A one-time* gene therapy for your patients with an RPE65-IRD1

 

*The individual administration procedure to each eye is performed on separate days within a close interval, but no fewer than 6 days apart.

IRD, inherited retinal dystrophy; RPE, retinal pigment epithelium.

References

  1. Novartis Pharmaceuticals UK Ltd. Luxturna® (voretigene neparvovec) Summary of Product Characteristics.
  2. Menghini M et al. Expert Opin Orphan Drugs 2020;8(2–3):67–78.
  3. Novartis. Novartis announces landmark EU approval for one-time gene therapy Luxturna® to restore vision in people with rare inherited retinal disease. Available at: https://www.novartis.com/news/media-releases/novartis-announces-landmark... [Accessed March 2023].
  4. Russell S et al. Lancet 2017;390(10097):849–860.
  5. Luxturna EMA Assessment Report. EMA/CHMP/700911/2018. 2018. Available at: https://www.ema.europa.eu/en/documents/assessment-report/luxturna-epar-p.... [Accessed March 2023].
  6. Maguire AM et al. Ophthalmology 2019;126;1273–1285.
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UK | March 2023 | 270402

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]