Biopharmaceutical company GenSight Biologics (Euronext Paris:SIGHT) and the 15-20 National Hospital in Paris announced on Tuesday the treatment of the first patient in the REVISE dose-ranging study of GS010, also known as LUMEVOQ.
The open-label, single-centre trial in France is planned to enrol 14 patients and was authorised by the French medicines agency ANSM in December 2025.
With REVISE underway, the 15-20 Hospital is currently the only institution in Europe conducting a clinical study involving GS010 and the only centre authorised to deliver named patient early access treatments with the therapy.
The study will evaluate two doses of GS010 for patients with Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene. LHON is a rare mitochondrial disease that leads to irreversible blindness in teens and young adults.
REVISE was requested by ANSM during the review of the named patient early access programme, which was also authorised in December 2025 and may be open to patients outside France subject to local regulations.
Enrolment in REVISE is prioritised for patients eligible for both programmes, with individual named patient requests evaluated by the agency.
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