Lineage Cell Therapeutics presented 36-month results from its Phase 1/2a study (NCT02286089) of RG6501 (OpRegen) in patients with geographic atrophy secondary to age-related macular degeneration at the Foundation Fighting Blindness Retinal Therapeutics Innovation Summit 2026.
The company reported that Cohort 4 patients who completed three-year follow-up (n=10) showed a mean gain of +6.2 ETDRS letters at 36 months, with a subgroup of five patients who received extensive OpRegen coverage recording a mean gain of +9.0 letters.
Quantitative optical coherence tomography analysis indicated sustained improvements in the external limiting membrane and RPE-complex areas in treated eyes through 36 months, while untreated fellow eyes showed declines; mean RPE-C area increased by 1.9 mm2 in treated eyes versus 3.8 mm2 in fellow eyes.
The open-label trial enrolled 24 patients across four cohorts and evaluated a thaw-and-inject formulation in Cohort 4. According to the company, imaging revealed partial restoration of outer retinal structure, including reappearance of an RPE layer and photoreceptor-associated features. These anatomical and functional changes after a single subretinal administration may reflect durable disease modification. The GAlette Phase 2a surgical optimization study (NCT05626114) is currently enrolling.
