GenSight submits MAA for lead therapy

GenSight Biologics (Euronext: SIGHT), a French biopharma focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, has announced that it has submitted the Marketing Authorization Application (MAA) for its lead product to the European Medicines Agency (EMA).

Lumevoq (lenadogene nolparvovec) is in development for vision loss due to Leber hereditary optic neuropathy (LHON), caused by mutation in the ND4 mitochondrial gene.

Bernard Gilly, co-founder and chief executive of GenSight, said: “This first regulatory submission for GenSight is a major milestone in our progression from a pure research organization to one with commercial capabilities. It validates a technology platform that has the potential to address the high unmet medical needs of patients suffering from a range of rare diseases. I would like to thank all GenSight employees and partners whose motivation, focus and effort made this submission possible.”