New clinical trial results are “challenging the long-held view that geographic atrophy (GA) causes irreversible damage”, according to biotech company developing OpRegen, a novel ‘off the shelf’ cell therapy.
Lineage Cell Therapeutics has announced 36-month results from patients enrolled its Phase 1/2a clinical study of RG6501 (OpRegen) in patients with GA secondary to age-related macular degeneration (AMD).1
The results, presented at Clinical Trials at the Summit (CTS) 2025, reveal:
- Mean vision gains of +9 letters among patients with extensive coverage of OpRegen cell therapy to the GA lesion site,
- Evidence of retinal structural improvement persisting out to three years, and
- Anatomical and functional improvements occurring following a single administration of OpRegen cell therapy.
“Long-term clinical outcomes following a single administration of OpRegen cell therapy are challenging the long-held view that GA causes irreversible damage, said Lineage CEO Brian Culley.
“A key finding from the Lineage-run Phase 1/2a trial was the importance of extensive placement of cells across the area of atrophy. Among patients who received fulsome coverage by OpRegen cell therapy, anatomical and functional benefits from a single administration have lasted for at least three years.
Long-term clinical outcomes following a single administration of OpRegen cell therapy are challenging the long-held view that GA causes irreversible damage
“Over this extended period, improved visual function is not a natural occurrence among patients suffering from GA, making these changes quite promising.
“Importantly, OpRegen-treated eyes have exhibited mean best corrected visual acuity (BCVA) scores above baseline at each of the 12-, 24-, and 36-month timepoints, demonstrating consistency as well as durability. In short, patients who received significant coverage of OpRegen cell therapy across their GA are exhibiting long-term outcomes consistent with meaningful disease stabilisation and even improvement,” Mr Culley said.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Through subretinal delivery, the cell therapy has the potential to support retinal cell health and improve retinal structure and function, counteracting RPE cell loss in GA lesions. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech.
Reference
- Lineage Cell Therapeutics, OpRegen® (RG6501) 36-Month Visual Acuity Results Featured at Clinical Trials at the Summit 2025 (media release, 23 June 2025) available at: businesswire.com/news/home/20250623206871/en/OpRegen-RG6501-36-Month-Visual-Acuity-Results-Featured-at-Clinical-Trials-at-the-Summit-2025 [accessed July 2025].
