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    LHON therapy: Excellent safety and potential visual benefits


    Regarding color vision, the same type of effect was seen when the patients were treated earlier rather than later in the disease process. “There was a significant effect in favor of the treated eye in the patients treated before 2 years after disease onset,” he said.

    In patients with a very narrow visual field, no benefit was seen after the injection. However, in those with a larger baseline visual field, there was a significant [P=0.014] effect of the injection in favor of the treated eye when compare to baseline.

    He concluded, “The duration of vision loss appears to impact the magnitude of the treatment effect for several visual functions.  Trends of positive treatment effects are seen in treated eyes within 2 years of onset of visual loss. The sustainability of the trends will be evaluated week 48 in all patients.   Therefore, two phase III trials (RESCUE NCT02652767, Principal Investigator Professor Nancy Newman, Atlanta,; REVERSE NCT02652780, Principal Investigator Professor Patrick Yu Wai Man, UK) in patients with early-onset disease are ongoing in Europe in Paris, London, Munich, and Parma and the US in Atlanta, Philadelphia, and Los Angeles to confirm the product efficacy.”

    Enrollment in the Phase III began in February 2016.


    Jose Alain Sahel, MD

    E: [email protected]

    This article was adapted from Dr. Sahel’s presentation at the 2015 meeting of the American Academy of Ophthalmology. Dr. Sahel is co-founder, consultant, and co-patenter of Gensight.

    The technology allowing the targeting of the protein to the mitochondrion has been developed by Marisol Corral-Debrinski, PhD, in collaboration with Dr. Sahel at Institut de la Vision, patented by the French INSERM and is exclusively licensed to GenSight Biologics, Paris. Dr. Sahel holds a patent on the AAV2/2 vector and is co-founder of GenSight Biologics. The trial (NCT02652780, Principal Investigator Dr. Catherine Vignal-Clermont )was sponsored by GenSight Biologics and conducted in collaboration with Professor Sahel and Dr. Catherine Vignal of the Quinze-Vingts National Ophthalmology Hospital/Institut de la Vision and Fondation Ophtalmologique Rotschild.


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