GenSight Biologics provided updates on early access programs and the ongoing REVISE clinical study for GS010, also known as LUMEVOQ, its gene therapy candidate for Leber hereditary optic neuropathy caused by a mutated ND4 mitochondrial gene, according to the company.
In France, individual applications submitted in February under the named patient Early Access Program were approved by the national medicines safety agency ANSM. The company said it is completing administrative steps to deliver the therapy to the 15-20 National Hospital, where treatments are scheduled for mid- and late March.
The REVISE dose-ranging study is progressing with the first patient treated in February and a second patient expected to be enrolled in the coming weeks, according to the company. The study is designed to evaluate two dose levels of the therapy in patients with ND4-associated Leber hereditary optic neuropathy.
Outside France, the company reported progress in other early access initiatives. In Israel, a second patient has been approved for treatment under a paid named patient program authorized by the Israeli Ministry of Health. In the United States, a second patient will receive treatment through the expanded access program after the U.S. Food and Drug Administration cleared a single patient investigational new drug application in January 2026, the company claims.
GenSight Biologics said expected payments from early access treatments in France could help support operations through 2026 while the company continues to pursue funding and advance clinical development of the therapy. GS010/LUMEVOQ has not received marketing authorization in any jurisdiction and remains under clinical investigation.
