GenSight Biologics has received a positive safety review for the Pioneer Phase I/II trial of GS030 combining gene therapy and optogenetics for retinitis pigmentosa treatment.
The Data Safety Monitoring Board confirmed that there were no 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. It suggested that the clinical trial should move forward without making any changes and should recruit the second cohort of three subjects, who will receive a larger dose of 1.5e11 vg.
Co-founder and chief executive officer of GenSight Bernard Gilly said: ‘We are pleased to be able to move forward GS030, our second clinical stage program. We look forward to confirm the safety of GS030 at higher doses and to demonstrate efficacy in restoring useful visual functions in RP patients.’