Lineage Cell Therapeutics, Inc. announced to present at Eyecelerator at 2023 American Academy of Ophthalmology the results of imaging analyses demonstrating evidence of rapid improvement in outer retinal structure and continued clinical benefit in subjects from a Phase 1/2a clinical study of RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD). OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).

Eyecelerator brings the future of ophthalmology into focus. GA typically affects both eyes. Eyecelerator brings the future of ophthalmology into focus.

A partnership between the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS), Eyecelerator advanceseye care innovation by connecting mission-driven entrepreneurs, investors, physicians, and business leaders through next-generation business conferences. Eyecelerator 2023 will provide a day of insightful, KOL-driven programs, including the latest industry advancements, investment trends, and innovative products disrupting eye care, The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a singleadministration of OpRegen delivered subretinally in patients with bilateral GA secondary to dry-form AMD. Twenty-four patients were enrolled into 4 cohorts.

The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new ?thaw-and-inject?

formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives are to evaluate the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.