Prescribing information

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The following research papers can be downloaded as useful resources for information on identifying and referring patients.

Preview of paper on the natural history of inherited retinal dystrophy due to biallelic mutations in the RPE gene.

EFFICACY AND SAFETY OF VORETIGENE NEPARVOVEC (AAV2-HRPE65V2) IN PATIENTS WITH RPE65-MEDIATED INHERITED RETINAL DYSTROPHY: A RANDOMISED, CONTROLLED, OPEN-LABEL, PHASE 3 TRIAL

This paper was published in The Lancet in 2017.

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Preview of pivotal paper on efficacy, safety and durability of voretigene neparvovec in RPE65 mutation-associated inherited retinal dystrophy.

EFFICACY, SAFETY, AND DURABILITY OF VORETIGENE NEPARVOVEC-RZYL IN RPE65 MUTATION–ASSOCIATED INHERITED RETINAL DYSTROPHY

This paper was published in Ophthalmology in 2019.

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Preview of pivotal paper from randomised phase 3 trial on the efficacy and safety of voretigene neparvovec in patients with RPE65-mediated inherited retinal dystrophy.

THE NATURAL HISTORY OF INHERITED RETINAL DYSTROPHY DUE TO BIALLELIC MUTATIONS IN THE RPE65 GENE

This paper was published in the American Journal of Ophthalmology in 2019.

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Preview of paper on longitudinal study of  RPE65-associated inherited retinal degenerations.

LONGITUDINAL STUDY OF RPE65-ASSOCIATED INHERITED RETINAL DEGENERATIONS

This paper was published in Retina in 2020.

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

Indication: 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

Reference

  1. Luxturna SmPC, 2020.
LUX20-C005e October 2020.
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