GenSight Biologics Updates on Early Access Programs and REVISE Study

GenSight Biologics has announced progress in their GS010/LUMEVOQ® early access programs and the ongoing REVISE study. This gene therapy is being developed to treat Leber Hereditary Optic Neuropathy (LHON) stemming from a mutated ND4 mitochondrial gene.

In France, the Named Patient Early Access (AAC) Program has been approved by ANSM, allowing treatments to begin at the National Hospital in March. The REVISE study is on track, having treated its first patient in February and expecting to enroll a second soon.

In Israel, a second patient has been approved for the Paid Named Patient Program. The US has also cleared the treatment for a second patient under the Expanded Access Program following the FDA's recent approval.

Payments for the French treatments are anticipated by March's end. These efforts are expected to extend the company's financial runway through 2026, supporting future endeavors like the RECOVER Phase III trial.