By: IPP Bureau
Last updated : December 31, 2025 4:09 pm
Applications include detailed scientific rationale and supporting clinical evidence
GenSight Biologics, the biopharma company pioneering gene therapies for retinal neurodegenerative diseases and CNS disorders, has announced that Israel’s Ministry of Health Pharmaceutical Division has granted the use of its candidate gene therapy in early access treatment of individual patients.
Early access to GS010/LUMEVOQ in Israel is reserved for patients facing life-threatening or severely debilitating conditions who cannot be treated with approved medicines or included in clinical trials. Treatment must be initiated by the patient’s physician and approved by both the hospital’s ethics committee (Helsinki Committee) and the Ministry of Health.
Applications include detailed scientific rationale and supporting clinical evidence, ensuring careful benefit-risk assessment for each patient. GenSight is working with local partner SK-Pharma to deliver GS010/LUMEVOQ to patients with urgent unmet needs.
“We are very pleased that we are able to provide limited quantities of GS010/LUMEVOQ for early access treatment worldwide, after authorization by relevant competent authorities,” said Laurence Rodriguez, CEO of GenSight Biologics.
“At the same time, we are gratified that the evidence that we could make available, regarding the clinical data on GS010, could support the compassionate treatment application.”
Rodriguez added, “For now, the company is giving the highest priority to ensuring sufficient supply for the REVISE dose-ranging study and named patient Early Access Program (AAC) recently authorized in France. These programs represent essential steps towards our ultimate goal of maximizing patient access to GS010/LUMEVOQ through full market authorizations in key markets of the world.”