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Statement of the DOG, the RG, and the BVA on the therapeutic use of voretigene neparvovec (Luxturna™) in ophthalmology. English version

January 2019
  • German Society of Ophthalmology (Deutsche Ophthalmologische Gesellschaft, DOG)Email author
  • German Retina Society e. V. (Retinologische Gesellschaft e. V., RG)
  • Professional Association of German Ophthalmologists (Berufsverband der Augenärzte Deutschlands e. V., BVA)
Leitlinien, Stellungnahmen und Empfehlungen
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Luxturna™ was approved in the European Union for the treatment of retinal dystrophy in patients with biallelic RPE65 mutations and sufficient viable retinal cells on 23 November 2018. The following article presents the treatment recommendations for Luxturna™ (Novartis, Basel, Switzerland) formulated on the basis of a consensus between the German Retina Society, the German Ophthalmological Society, and the German Professional Association of Ophthalmologists.

1 Key messages of the statement

All of the following conditions should be met prior to performing treatment with Luxturna™:
  • The diagnosis of retinal dystrophy has been clinically confirmed. Grade of recommendation: ⇑⇑

  • Biallelic (homozygous or compound heterozygous) sequence variants in the RPE65 gene have been identified as the cause of disease. Ideally, identification is performed by means of segregation analysis in the parents. Grade of recommendation: ⇑⇑

  • It has been established that sufficient target cells are available to ensure...

Stellungnahme von DOG, RG und BVA zur therapeutischen Anwendung von voretigene neparvovec (Luxturna™) in der Augenheilkunde. Englische Version

Stand Januar 2019

Notes

Editorial board

Prof. Dr. med. Dominik Fischer, Tübingen, Germany (lead editor)

Prof. Dr. med. Bernd Bertram, Aachen, Germany

Prof. Dr. med. Ulrich, Kellner, Siegburg, Germany

Prof. Dr. med. Hansjuergen Agostini, Freiburg im Breisgau, Germany

Prof. Dr. med. Birgit Lorenz, Giessen, Germany

Dr. med. Philipp Herrmann, Bonn, Germany

Compliance with ethical guidelines

Conflict of interest

See Table 2 in the appendix.

This article does not contain any studies with human participants or animals performed by any of the authors.

The supplement containing this article is not sponsored by industry.

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Copyright information

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2019

Authors and Affiliations

  • German Society of Ophthalmology (Deutsche Ophthalmologische Gesellschaft, DOG)
    • 1
    Email author
  • German Retina Society e. V. (Retinologische Gesellschaft e. V., RG)
    • 2
  • Professional Association of German Ophthalmologists (Berufsverband der Augenärzte Deutschlands e. V., BVA)
    • 3
  1. 1.German Society of Ophthalmology (Deutsche Ophthalmologische Gesellschaft)MunichGermany
  2. 2.German Retina Society (Retinologische Gesellschaft e. V.)FreiburgGermany
  3. 3.Professional Association of German Ophthalmologists (Berufsverband der Augenärzte Deutschlands e. V.)DüsseldorfGermany

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