GenSight: first injections scheduled for December

(CercleFinance.com) - GenSight Biologics climbs 9% on Wednesday's trading on the Paris Bourse after submitting a compassionate access application to the French National Agency for the Safety of Medicines and Healthcare Products (ANSM) for its experimental treatment of Leber's hereditary optic neuropathy (NOHL).


The biopharmaceutical company explains that the submission of the dossier - with the aim of preparing for the resumption of the compassionate access program in France - attests to the successful manufacture of its Lumevoq.

This gene therapy involves the blending of two batches of GMP-compliant compounds to optimize the number of vials available for clinical use, as well as the successful completion of all required quality control tests.

According to GenSight, the updated dossier filed with the ANSM will enable the latter to examine individual requests for compassionate access (AAC).

The first injections are scheduled for December 2024.

Leber's hereditary optic neuropathy (NOHL) is a rare mitochondrial disease, transmitted from mother to child, characterized by a degeneration of the retinal cells and causing a sudden and irreversible loss of vision, generally leading to legal blindness.

These symptoms appear mainly in adolescents and young adults.

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