Lineage Cell Therapeutics’ OpRegen (RG6501) is gaining attention as a promising one-time allogenic cell therapy for geographic atrophy (GA), following encouraging results from its Phase I/IIa trial. With limited treatment options currently available, OpRegen’s ability to improve and stabilize vision positions it as a potential breakthrough in addressing a critical unmet need in GA management, says GlobalData, a leading data and analytics company.

The current GA treatment landscape consists of only two therapies, Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol).

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 retinal pigment epithelium (RPE) cells, reestablishing the essential photoreceptor-RPE cellular interface, thereby restoring visual function in degenerative retinal pathologies. This cell therapy is a subretinal injection.

Long-term data from the completed Phase I/IIa trial demonstrated that throughout the study duration, at months 12, 24 and 36, functional and anatomical benefits have persisted; mean BCVA scores recorded were consistently above the baseline, proving its durability; and it proved able to stabilize 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 [ETDRS]).

Sara Reci, MSc, Managing Pharma Analyst at GlobalData, comments: “These findings highlight OpRegen’s potential to alleviate treatment burden, an imperative factor in the management of patients with GA.”

The key opinion leaders (KOLs) interviewed by GlobalData have stressed the importance of treatments that can prevent the progression of GA and visual deterioration associated with it, highlighting this as an unmet need.

Reci concludes: “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.”