36-Month Results of OpRegen® Therapy for Geographic Atrophy to Be Presented at Clinical Trials at the Summit 2025

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company, has announced that 36-month results from its Phase 1/2a clinical study of RG6501 (OpRegen) will be presented at the Clinical Trials at the Summit 2025 in Carlsbad, California. The study, registered on ClinicalTrials.gov with the identifier NCT02286089, focuses on RG6501 as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). RG6501, also known as OpRegen, is an allogeneic cell therapy designed to treat GA, a severe form of AMD characterized by the progressive loss of vision due to the death of photoreceptors and retinal pigment epithelial cells in the macula. This region of the eye is responsible for central vision, and GA can significantly impact a person's ability to read, drive, and recognize faces. The Phase 1/2a clinical trial, which commenced in 2014, aims to evaluate the safety and preliminary efficacy of RG6501 in patients with GA. Over the course of 36 months, researchers have monitored the effects of the therapy on patient outcomes, including visual function and retinal health. The trial involves a small cohort of patients, allowing for a detailed analysis of individual responses to the treatment. Key findings from the study include: Safety: The therapy has shown a favorable safety profile, with patients experiencing minimal adverse reactions. This is crucial for advancing the therapy into later-stage trials and eventual clinical use. Efficacy: Initial data suggest that RG6501 may help preserve or improve visual function in some patients. Further analysis will determine the consistency and magnitude of these benefits. Mechanism of Action: The allogeneic nature of RG6501 means that it uses donor cells to regenerate and support the damaged retinal tissue. These cells are designed to replace the lost retinal pigment epithelial cells and possibly protect remaining photoreceptors. The presentation at Clinical Trials at the Summit 2025 will provide detailed insights into the 36-month data, offering valuable information to the scientific and medical communities. This summit is a premier event for discussing advancements in clinical research and new treatments for various diseases, making it an ideal platform to share the results of this innovative study. Dr. Brian Culley, CEO of Lineage Cell Therapeutics, expressed optimism about the future of RG6501, stating, "We are excited to share the comprehensive 36-month data from our Phase 1/2a clinical trial of OpRegen. These results represent a significant milestone in our efforts to develop effective treatments for geographic atrophy. We believe that OpRegen has the potential to transform the lives of patients suffering from this devastating condition." The summit, scheduled for early 2025, will feature a panel of leading experts in ophthalmology and regenerative medicine, who will review the data and provide critical feedback. This feedback will be instrumental in refining the therapy and planning the next steps in its development. Age-related macular degeneration is a leading cause of vision loss in older adults, affecting millions worldwide. Geographic atrophy, a late-stage manifestation of AMD, currently lacks effective treatments, making the progress of RG6501 particularly significant. Lineage Cell Therapeutics' commitment to developing such therapies highlights the company's dedication to addressing unmet medical needs. As the data are shared and evaluated, they will contribute to a broader understanding of how cell therapies can be used to treat degenerative eye diseases. The potential success of RG6501 could pave the way for similar treatments and accelerate research in the field of regenerative medicine. In summary, the presentation of 36-month results from the Phase 1/2a clinical trial of RG6501 at Clinical Trials at the Summit 2025 marks a pivotal moment in the development of treatments for geographic atrophy. The promising safety and efficacy data, along with expert feedback, will guide further research and potentially bring hope to millions of patients affected by this condition.