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    OpRegen

    Other names: RG6501

    Modality: Retinal pigment epithelium (RPE) cell replacement therapy

    Disease State: Geographic Atrophy (GA), Atrophic Age-Related Macular Degeneration (AMD)

    Summary

    OpRegen is an investigational retinal pigment epithelium (RPE) cell therapy for the treatment of GA1

    Clinical Trials

    OpRegen
    NCT ID Study Phase Enrollment Status Study Title
    NCT05626114 Phase II Recruiting A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251 View details
    NCT02286089 Phase I / Phase II Active, not recruiting Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration View details

    Proposed Mechanism of Action

    Allogeneic Retinal Pigment Epithelium (RPE) stem cell therapy will replace atrophic and dysfunctional RPE cells.2

    1. Roche: Product Development Portfolio. Roche website. Published April 23, 2026. Accessed May 6, 2026. https://www.roche.com/​solutions/​pipeline
    2. Lineage Cell Therapeutics. OpRegen® (RG6501) 36-Month Visual Acuity Results Featured at Clinical Trials at the Summit 2025. Lineage Cell Therapeutics. Published June 23, 2025. Accessed August 17, 2026. https://investor.lineagecell.com/​node/​24001/​pdf#:~:text=Mean%20​change%20​in%20​BCVA%20​among%20​treated%20​eyes,bleb%20​coverage%20​of%20​their%20​GA%20​area%20​was

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    TOP

    • AMD
      age-related macular degeneration

    • AO
      adaptive optics

    • cGMP
      current Good Manufacturing Practice

    • GA
      geographic atrophy

    • hESC
      human embryonic stem cell

    • MoA
      mode of action

    • NIH
      US National Institutes of Health

    • RPE
      retinal pigment epithelium

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