HEALIOS K.K. is developing a treatment with Sumitomo Pharma Co. Ltd. utilizing retinal pigment epithelial (RPE) cells derived from allogeneic iPS cells. Company announced that after the completion of the 30-day review by the Pharmaceuticals and Medical Devices Agency (PMDA) regarding the protocol of the phase 1/2 study in patients with RPE tear (hereinafter referred to as "the clinical study"), the preparation of the clinical study has been completed and the study is being initiated.

Outline of the clinical study: Test product: HLCR011: iPS cell-derived retinal pigment epithelial (RPE) cells suspension; Development stage: Phase 1/2; Subjects: Patients with retinal pigment epithelium tear; Design for the clinical study (target number cases): Part 1: Unmasked, uncontrolled (one HLA-mismatched subject); Part 2: Unmasked, randomized (treatment/observation groups, 10 subjects/group, total 20 subjects); Primary endpoint: Safety of subretinal administration of HLCR011 in patients with retinal pigment epithelium tear (number and ratio of subjects with observed adverse events); Secondary endpoint (efficacy): Visual function evaluation. The clinical study is a multicenter, unmasked, randomized study. Sumitomo Pharma is now selecting clinical study sites.

Subjects will be enrolled immediately after the completion of the preparation, including conclusion of contracts with the clinical study sites.