GenSight Biologics announced that GS010/LUMEVOQ has received regulatory approval from Agence nationale de sécurité du médicament et des produits de santé (ANSM)—along with an Ethics Committee—to conduct its dose‑ranging study named REVISE in France.
The REVISE trial is an open‑label, single‑center Phase II study targeting 14 patients with confirmed ND4‑mutation associated Leber Hereditary Optic Neuropathy (LHON), who have experienced vision loss for between 6 months and 1.5 years. Patients will be assigned equally to one of two clinical dose levels. The primary endpoint is the change in Best Corrected Visual Acuity (BCVA) 1.5 years post‑treatment compared with baseline.
According to the company, the approved study also supports the ongoing review by ANSM of a proposed early‑access (AAC) program for LUMEVOQ in France.
GenSight said the REVISE study is planned to begin in January 2026. In parallel, the company continues to finalise its manufacturing transfer to its new partner and prepares the protocol for a pivotal Phase III trial.
