OpRegen
From Wikipedia, the free encyclopedia
administrationSubretinal injection
- Investigational
| Clinical data | |
|---|---|
| Trade names | OpRegen |
| Other names | RG6501 |
| Routes of administration | Subretinal injection |
| Legal status | |
| Legal status |
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OpRegen (also known as RG6501) is an investigational allogeneic cell therapy developed by Lineage Cell Therapeutics for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).[1][2] The therapy consists of human retinal pigment epithelial (RPE) cells administered via subretinal injection as a single treatment.[3]
OpRegen is designed to counteract the dysfunction and loss of retinal pigment epithelial cells that occurs in geographic atrophy by providing cellular support to remaining retinal cells within atrophic areas.[4] The therapy utilizes allogeneic RPE cells derived from human embryonic stem cells through a directed differentiation process, which are then transplanted into the subretinal space to restore function in damaged retinal tissue.[5]
Development and collaboration
OpRegen is currently being developed under an exclusive worldwide collaboration between Lineage Cell Therapeutics, Roche, and Genentech.[1] The therapy represents one of Lineage's three allogeneic "off-the-shelf" product candidates targeting markets with billion-dollar opportunities.[6]
Clinical trials
Phase 1/2a study
The primary Phase 1/2a clinical trial of OpRegen is an open-label, single-arm, multi-center study investigating the safety and tolerability of a single subretinal administration in patients with geographic atrophy.[7] The study includes patients with varying degrees of vision impairment and evaluates both safety parameters and preliminary efficacy measures.[8][9]
The primary objective focuses on evaluating safety and tolerability through assessment of treatment-emergent adverse events, while secondary objectives include evaluating preliminary therapeutic activity by measuring changes in visual function and retinal structure.[8]
Phase 2a study
Following positive Phase 1/2a results, Genentech launched a Phase 2a study of RG6501 (OpRegen) in November 2022, known as the "GAlette study."[1] This advancement represents a significant milestone in the clinical development program for geographic atrophy treatment.[10]