First Patient Treated in France for GenSight's REVISE Study Evaluating ND4-LHON Gene Therapy

The 15-20 National Hospital (l’Hôpital national des 15-20) in Paris and GenSight Biologics announced that the first patient has been treated in the REVISE dose-ranging clinical study.

REVISE is an open-label, single-center study conducted at the 15-20 National Hospital and aims to enroll 14 patients in France. The study will investigate two doses of GS010/Lumevoq, GenSight Biologics’ investigational gene therapy for the treatment of Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene.

With the initiation of REVISE, the 15-20 National Hospital is currently the only institution in Europe conducting a clinical study involving GS010. The hospital also holds the unique distinction of being the sole institution in Europe authorized to administer GS010 under a named patient early access program (Autorisation d’Accès Compassionnel, AAC).

The REVISE study was requested by the French medicines agency, ANSM (Agence nationale de sécurité du médicament et des produits de santé), during its review of the application for the GS010 named patient early access program. Authorization for the study was granted in December 2025.

“We at GenSight are gratified that two avenues are now available for patients to be treated with GS010 in France,” said Dr. Magali Taiel, Chief Medical Officer of GenSight Biologics. “The unmet medical need among ND4-LHON patients and the urgency to treat the condition continue to animate our efforts to advance the clinical development of the gene therapy, including our push to begin a new phase 3 clinical study by the end of this year.”

LHON is a rare, maternally inherited mitochondrial genetic disease characterized by degeneration of retinal ganglion cells, leading to rapid and usually irreversible vision loss that often progresses to legal blindness. The ND4 mitochondrial mutation is the most common cause of LHON and is associated with the poorest prognosis among the major LHON mutations.