GenSight Biologics reports positive data in Phase III clinical trial of GS010 gene therapy for Leber Hereditary Optic Neuropathy

Durable improvement in best-corrected visual acuity (BCVA), as GS010-treated eyes sustain +15.4 ETDRS letters equivalent improvement versus baseline and +28.1 ETDRS letters equivalent versus nadirBilateral improvement continues in key visual functions BCVA and contrast sensitivityResponder analyses suggest improved clinical outcomes for GS010-treated eyes relative to sham-treated eyesGS010 safety and tolerability established over the course of the trialBriefing packages incorporating findings under preparation for meetings with regulatory authorities GenSight Biologics today reported a first set...

GenSight Biologics announces positive DSM Board review and continuation of PIONEER Phase I/II clinical trial of GS030 gene therapy for Retinitis Pigmentosa

GenSight Biologics announced that the independent Data Safety Monitoring Board (DSMB) completed its first safety review of the ongoing PIONEER Phase I/II clinical trial of GS030 combining gene therapy and optogenetics for the treatment of Retinitis Pigmentosa. The DSMB confirmed the absence of any safety issues for the first cohort of three subjects who received a single intravitreal injection of 5e10 vg combined with a wearable optronic visual stimulation device. The...