Pharma Pioneer

OpRegen® Phase 1/2a 24-Month Data to Highlight 2024 Retinal Therapy Summit

19 May 2024
3 min read

A clinical-stage biotech firm, Lineage Cell Therapeutics, has announced the upcoming presentation of two-year outcomes from a Phase 1/2a study of RG6501, also known as OpRegen, for patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). The results will be showcased at the 2024 Retinal Cell & Gene Therapy Innovation Summit, co-hosted by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute, on May 3, 2024, at the Hyatt Regency Seattle. The study focuses on the delivery of allogeneic retinal pigment epithelial (RPE) cells to potentially restore RPE cell loss in GA patients, thereby improving their retinal health and function. The OpRegen therapy is being developed in collaboration with Roche and Genentech and is currently under evaluation in a Phase 2a clinical trial (ClinicalTrials.gov Identifier: NCT05626114).

The Foundation Fighting Blindness, established in 1971, is recognized as the leading private funder of retinal disease research globally. It has significantly contributed to the identification of over 270 genes associated with retinal diseases and the initiation of more than 40 clinical trials for potential treatments.

The OHSU Casey Eye Institute, a leading academic medical center, has been at the forefront of eye care since 1945, working to uncover the causes of eye diseases and develop new treatment methods.

The Phase 1/2a clinical trial of OpRegen is an open-label, single-arm, multi-center study that investigates the safety and tolerability of a single subretinal administration of the therapy in patients with GA. The study includes patients with varying degrees of vision impairment and employs a new "thaw-and-inject" formulation of OpRegen for ease of use.

Geographic atrophy, an advanced form of AMD, is a significant cause of adult blindness, affecting a minimum of 5 million individuals worldwide. It is characterized by the severe loss of visual function and often occurs in both eyes.

Lineage Cell Therapeutics is engaged in developing novel cell therapies to fulfill unmet medical needs, using its proprietary cell-based technology platform. Their pipeline includes therapies for various conditions, including spinal cord injuries, auditory neuropathy, vision loss due to photoreceptor dysfunction, and more.

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