(CercleFinance.com) – GenSight Biologics announces the successful production of the first pilot batch incorporating improvements in the manufacturing process of LUMEVOQ, the gene therapy for Leber’s hereditary optic neuropathy (LHON)
This batch was the first to implement a series of targeted corrective measures relating to the reinforcement of the control of the procedures as well as the installation of a reinforced on-site supervision.
“We continue to work tirelessly to get LUMEVOQ approved, in order to provide patients with LHON with a therapeutic solution as soon as possible and in the safest way,” said Bernard Gilly, CEO and co-founder of GenSight Biologics. .
The company is now moving forward with confidence to resume the early access program, clinical development and prepare for commercialization.
GenSight expects to obtain the opinion of the European Committee for Medicinal Products for Human Use (CHMP) by the third quarter of 2023, followed by commercial launch in late 2023.
The GenSight Biologics stock gained +19% on the stock market.