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United States. Securities and Exchange Commission

Lineage Cell Therapeutics Announces Phase 2a Study of OpRegen for Geographic Atrophy

Strategic Insights

— 2 min read

Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology company, has announced that its partner Genentech has launched a Phase 2a clinical study of OpRegen (RG6501), a retinal pigment epithelial cell therapy, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study aims to evaluate the safety and activity of OpRegen in approximately 30 to 60 patients with GA, and to optimize subretinal surgical delivery of the therapy.

The primary objectives of the study are to evaluate the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography (SD-OCT) imaging within 3 months following surgery.

GA is an advanced form of AMD, characterized by severe loss of visual function and a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are currently no approved treatment options available for patients with GA.

Key Takeaways:

  • The Phase 2a study aims to evaluate the safety and activity of OpRegen in approximately 30 to 60 patients with GA secondary to AMD.
  • The primary objectives of the study are to evaluate subretinal surgical delivery of OpRegen and its safety as measured by procedure-related adverse events.
  • A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure using SD-OCT imaging within 3 months following surgery.
  • The study will provide insights for the future development of OpRegen, a treatment for GA with no approved therapies available.
  • OpRegen has demonstrated the potential to slow, stop, or reverse the progression of GA in patients with GA in a previous Phase 1/2a clinical trial.

Statistics:

  • At least 5 million people globally are affected by advanced AMD, including GA.
  • The study aims to enroll approximately 30 to 60 patients with GA secondary to AMD.
  • The primary objectives of the study will be evaluated at 3 months following surgery.
  • The study will provide insights for the future development of OpRegen for GA, a disease with no approved therapies available.

Sources:

  • "Lineage Cell Therapeutics, Inc. (Lineage), today announced that its partner Genentech has launched a Phase 2a clinical study of OpRegen, a retinal pigment epithelial cell therapy, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)." (Source: BusinessWire)
  • "The Phase 2a study will evaluate the safety and activity of OpRegen in approximately 30 to 60 patients with GA secondary to AMD." (Source: BusinessWire)
  • "GA is an advanced form of AMD, characterized by severe loss of visual function and a leading cause of adult blindness in the developed world, affecting at least 5 million people globally." (Source: Lineage Cell Therapeutics, Inc.)

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