BRIEF—FDA setback for GenSight's Lumevoq

A US regulatory setback sent the shares of French ophthalmics company GenSight Biologics tumbling yesterday.

As planned, GenSight provided the US Food and Drug Administration with an update on the clinical data generated to date with Lumevoq (lenadogene nolparvovec), including the indirect comparison to Natural History and the REFLECT data, in the context of a Type-C meeting held in December 2021.

The agency provided feedback in January 2022 recommending that the company conduct an additional placebo-controlled trial to bolster the demonstration of Lumevoq efficacy in view of the unexpected bilateral effect observed in unilaterally treated patients in the RESCUE, REVERSE and REFLECT trials.

GenSight says it is engaging with the FDA on the design of such a trial and aims to initiate it as soon as possible in 2022.

GenSight is developing the gene therapy for the treatment of vision loss due to Leber hereditary optic neuropathy (LHON).