- Lineage Cell Therapeutics Inc LCTX has updated interim results from its ongoing Phase 1/2a study of its lead product candidate, OpRegen, for dry age-related macular degeneration (AMD) with geographic atrophy (GA).
- OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space.
- Data were presented at the Association for Research in Vision and Ophthalmology Annual Meeting.
- Additional data presented include 24 patients enrolled in the study, including all 12 patients treated in Cohort 4, which have better baseline vision and smaller GA areas than earlier cohorts.
- Improvements in best-corrected visual acuity (BCVA) for Cohort 4 patients reached up to +19 letters.
- In contrast, 10/12 of the patients' untreated eyes were below pre-treatment baseline values simultaneously.
- Among the newly reported data, three of the more recently treated Cohort 4 patients exhibited marked improvements in BCVA, ranging from +7 to +16 letters.
- Two additional Cohort 4 patients experienced a gain of 2 letters from their baseline values, while one patient measured seven letters below the baseline.
- Overall, OpRegen was well tolerated with no unexpected adverse events or serious adverse events.
- Also, evidence of durable engraftment of OpRegen RPE cells has extended to more than five years in the earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.
- Price Action: LCTX shares are down 0.4% at $2.74 on the last check Monday.
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