Sumitomo Pharma America has treated the first patient in its Phase I/IIa clinical trial of DSP-3077 for adults with non-syndromic retinitis pigmentosa (RP).
The patient has undergone a subretinal implantation of the regenerative cell therapy.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
DSP-3077, the company’s investigational therapy, utilises allogeneic retinal sheets that are derived from induced pluripotent stem (iPS) cells.
The open-label, single-arm, dose-escalation study is designed to assess the tolerability and safety of two dose levels of DSP-3077 delivered via a single subretinal injection.
Its primary focus is on safety in adults with RP while secondary objectives include evaluation of engraftment, therapeutic response, and the performance of the device used for delivery.
A cohort structure defines treatment groups by visual acuity and dose, with each of three cohorts including four participants and a total planned enrolment of 12 patients.
RP is described as a rare, hereditary degenerative eye condition. The disease typically leads to loss of night vision and peripheral vision, progressing in most cases to central vision impairment.
DSP-3077 utilises a 3D retinal organoid, produced through a self-organising cell culture technique known as the SFEBq method.
This technology, which generates multilayered retinal tissue with a rich presence of photoreceptor precursors, was initially developed at RIKEN, a research institute in Japan, and later optimised through collaborations involving Sumitomo Chemical, Sumitomo Pharma, RACTHERA, and S-RACMO.
Sumitomo Pharma America president and CEO Tsutomu Nakagawa said: “We are encouraged by the potential that iPS cells may hold for treating degenerative, debilitating conditions like RP that currently have few therapeutic options, and this first patient treated is a notable milestone for our company.
“Being able to provide this investigational treatment to our first study participant is not only a great honour, but a very important milestone in the development of DSP-3077, one that will aid in better understanding how it and future iPSC therapies could help improve the lives of RP patients and their families.”
In March 2026, the US Food and Drug Administration granted orphan drug designation to DSP-3077 for the treatment of RP.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
