(News Bulletin 247) – GenSight Biologics today provides an update on the manufacturing and commercialization timelines for LUMEVOQ, the company’s gene therapy for Leber’s hereditary optic neuropathy.

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Two engineering batches were successfully manufactured. A GMP batch (good manufacturing practices) was programmed before launching the production of the validation campaign necessary to complete the file currently examined by the European Medicines Agency (EMA).

Due to a problem at TFS in handling the downstream process, the batch was aborted. The exact cause is under investigation before initiating the validation campaign.

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‘ Even if it is limited, I regret this delay. However, we are confident that the measures implemented will lead to a successful validation campaign,” said Bernard Gilly, CEO and co-founder of GenSight Biologics.

GenSight now expects to receive the opinion of the European Committee for Medicinal Products for Human Use (CHMP) by Q1 2024 (previously end of September 2023), shortly to be followed by the commercial launch of LUMEVOQ in Europe.

In parallel, GenSight will resume its interactions with the US Food and Drug Administration (FDA) in order to obtain a regulatory pathway in the United States.

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