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Recently, GenSight Biologics announced that the US FDA has granted GS030 fast track qualification
Retinitis pigmentosa is a neurodegenerative eye disease in which patients usually begin to have vision deterioration during childhood
GS030 combines a single intravitreal injection of gene therapy (GS030-DP) with a wearable photoelectric visual stimulation device (GS030-MD)
This fast track qualification is based on the positive results of an ongoing Phase 1/2 dose-escalation clinical trial, and aims to evaluate the safety and tolerability of GS030 in 12-18 subjects with advanced retinitis pigmentosa
Reference materials:
[1] GenSight Biologics Announces FDA Grant of Fast Track Designation for Optogenetic Therapy GS030 as Treatment for Retinitis Pigmentosa.