HEALIOS K.K. announced it is developing a treatment using retinal pigment epithelial (RPE) cells derived from allogeneic iPS cells with Sumitomo Pharma Co. Ltd. announced that Sumitomo Pharma has submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) a clinical trial notification for a phase 1/2 study in patients with RPE tear. This clinical trial is scheduled to start after a 30-day review period.

Sumitomo Pharma and Healios will promote this clinical trial with the aim of commercializing the treatment using RPE cells derived from allogeneiciPS cells and confirming its efficacy and safety at an early stage, in order to bring the treatment to patients as soon as possible. RPE tear is a condition in which the RPE cell layer is torn, contracted, and partially defective due to age-related macular degeneration (AMD) or other causes. It causes visual field defects and vision loss, but currently no treatment for this condition has been established.

If RPE cells are missing but photoreceptor function is preserved, RPE cell transplantation can be expected to maintain or restore visual function. There is no confirmed impact of this matter on business performance for the fiscal year ending December 31, 2023 at this time.