Paris-based Gensight Biologics announced it has signed a manufacturing agreement with Catalent, a US-based contract development and manufacturing organization, to produce commercial batches of its gene therapy Lumevoq. According to the company, this partnership represents a critical step toward ensuring consistent supply and meeting potential market demand.
Lumevoq is an investigational gene therapy targeting vision loss from Leber hereditary optic neuropathy (LHON), a rare mitochondrial genetic disorder. The company said that Catalent will handle large-scale production of Lumevoq’s active pharmaceutical ingredient and its fill-finish operations at Catalent’s facilities in Maryland and Italy.
Gensight Biologics claims that the partnership supports its commercialization plans in Europe, where it expects a potential market launch following European Medicines Agency (EMA) review. The company also stated that working with Catalent will help it scale production to industrial levels required for market supply.
The agreement follows previous manufacturing arrangements with other partners that faced operational challenges. Gensight Biologics noted that Catalent’s expertise and global manufacturing infrastructure are key to mitigating such risks and advancing its commercial strategy.
The company also highlighted that it is continuing its engagement with regulatory authorities as part of its market access efforts for Lumevoq. No financial details of the manufacturing agreement were disclosed.
