Lineage Cell Therapeutics recently revealed the results of the company’s Phase I/IIa trial for OpRegen. This therapy is currently in development for geographic atrophy (GA). The current GA treatment landscape consists of only two therapies, Syfovre and Izervay. OpRegen is anticipated to poise itself as a novel one-time allogeneic cell therapy within the GA space.
OpRegen is a suspension of embryonic stem cell-derived retinal pigment epithelial (RPE) cells and works by restoring retinal function through targeted replacement of dysfunctional RPE cells, reestablishing the essential photoreceptor-RPE cellular interface, thereby restoring visual function in degenerative retinal pathologies. This cell therapy is a subretinal injection. The completed Phase I/IIa trial – a multicentre, single-arm, open-label dose escalation study – was designed to assess OpRegen’s efficacy, safety, and effect on quality of life. It was composed of four cohorts (n=24): Cohorts 1 (n=3), 2, (n=3) and 3 (n=6) included patients who were legally blind and had a best-corrected visual acuity (BCVA) of 20/200 or worse, while cohort 4 (n=12) included patients with less advanced GA who had impaired vision and a BCVA of 20/65 to 20/250. The latter patient cohort was treated with a different formulation of OpRegen that allows for immediate use upon thawing.
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Long-term data from the completed Phase I/IIa trial, presented by Christopher D Reimann, MD, vitreoretinal surgeon and fellowship director, Cincinnati Eye Institute and University of Cincinnati School of Medicine, during the Clinical Trials at the Summit (CTS) 2025 event, which took place on June 21 in Las Vegas, demonstrated that throughout the study duration, at months 12, 24, and 36, functional and anatomical benefits persisted; mean BCVA scores recorded were consistently above the baseline, proving its durability; and it proved able to stabilise and improve GA. Patients who completed the three-year follow-up (n=10) presented with a mean increase in BCVA of 6.2 letters (Early Treatment Diabetic Retinopathy Study).
Key opinion leaders interviewed by leading data and analytics company GlobalData stressed the importance of treatments that can prevent the progression of GA and visual deterioration associated with it, highlighting this as an unmet need.
Thus, OpRegen shows notable potential as a future treatment option for GA patients and clinicians, given the benefits established in its Phase I/IIa trial. Should Lineage Cell Therapeutics’ Phase II trial for OpRegen, GAlette, continue to affirm these benefits, OpRegen could emerge as an exciting therapy that offers much-needed durability in the management of GA patients.
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