on GENSIGHT BIOLOGICS S.A. (EPA:SIGHT)
GenSight Biologics Submits LUMEVOQ® Dossier to ANSM
GenSight Biologics has submitted an updated regulatory dossier to France's ANSM. This aims to restart the early access program for LUMEVOQ®. The gene therapy targets Leber Hereditary Optic Neuropathy (LHON), a rare condition leading to vision loss. The submission details successful production and quality control, ensuring adequate clinical supply.
CEO Laurence Rodriguez emphasizes this marks a transition from manufacturing to regulation, aligning with LHON community expectations for rapid early access. The company plans first injections at Quinze-Vingts hospital by December 2024's end.
The updated file assists ANSM's review for compassionate use requests under France's AAC program. GenSight aims to collaborate with the agency to streamline the assessment process.
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