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ARTICLE | Clinical News

GenSight's GS010 misses in Phase III for neuropathy

April 6, 2018 2:47 PM UTC

GenSight Biologics S.A. (Euronext:SIGHT) reported that GS010 (rAAV2/2-ND4) missed the primary endpoint of improving visual acuity in the Phase III REVERSE trial to treat Leber's hereditary optic neuropathy (LHON).

On the 37-patient trial's primary endpoint, both treated and untreated eyes achieved an improvement of 11 letters in best corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart from baseline to week 48. Patients received a single intravitreal injection of GS010 in one eye and sham injection in the other eye. GenSight said the "unexpected improvement" in visual acuity in the untreated eye suggests a "bilateral treatment effect" that the company plans to further investigate...

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