- The FDA approves BioTime (NASDAQ:BTX) subsidiary Cell Cure Neurosciences' IND for OpRegen, its human embryonic stem cell-derived (hESC) therapeutic candidate for the treatment of age-related macular degeneration (AMD) or geographic atrophy (GA).
- The 15-patient Phase 1/2a clinical trial is a dose escalation safety and preliminary efficacy study of hESC-derived Retinal Pigment Epithelial (RPE) cells transplanted subretinally in patients with advanced dry-form AMD or GA. Three doses ranging from 50K to 500K cells will be evaluated. Patients will be followed for 12 months post treatment.
- There are currently no FDA-approved therapies for the dry form of AMD.