GenSight: market hails progress on Lumevoq
In a press release, the biopharmaceutical company states that the main features of its new Phase III trial on Lumevoq, its proposed gene therapy for the treatment of Leber's hereditary optic neuropathy (NOHL), have been approved.
This randomized trial, dubbed 'Recover', will be divided into two treatment arms: a control arm in which a simulated procedure mimics an injection into each eye without any substance being injected, and an active arm, in which subjects will receive a bilateral intravitreal injection of Lumevoq.
According to the EMA, this study protocol appears acceptable for assessing the benefits of the drug in patients requiring treatment of both eyes.
The study was designed to address questions raised by an EMA expert committee, which led GenSight to withdraw this dossier last April in order to discuss the agency's reservations.
GenSight plans to initiate the study in the second quarter of 2024, and to complete it by the second half of 2026.
The biotech adds that it intends to share the main features of the protocol with other regulatory authorities, such as the UK Agency (MHRA) and the US FDA.
The stock is currently up 32%, making it the biggest gainer on the Paris market, but is still down 84% since the start of the year.
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