Diamond Pharma, GenSight submit EMA application for ocular gene therapy

By The Science Advisory Board staff writers

French biotechnology firm GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency (EMA) for its ocular gene therapy.

Lenadogene neparvovec (Lumevoq) gene therapy is designed to treat vision loss caused by Leber hereditary optic neuropathy, a mitochondrial genetic disease. The disease mainly affects young boys and most patients become legally blind.

The application was submitted with assistance from regulatory consulting group Diamond Pharma Services. Diamond provided GenSight with regulatory, preparation, authoring, and quality and compliance support, according to the company.

GenSight and Diamond expect a decision from the EMA in late 2021. GenSight is headquartered in Paris and focuses on the development and commercialization of gene therapies for retinal neurodegenerative diseases and central nervous system disorders.


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