The first patient has been dosed in an ongoing phase 1/2a clinical trial with a new thaw-and-inject formulation of OpRegen, delivered with the Orbit subretinal delivery system, BioTime announced in a press release.
The open-label, dose escalation trial will evaluate the safety and efficacy of OpRegen, a human embryonic stem cell-derived retinal pigment epithelium transplant therapy, in patients with dry age-related macular degeneration.
“We are excited to be evaluating the FDA-cleared Orbit SDS in the next six patients of our phase 1/2a study,” Brian M. Culley, BioTime CEO, said in the release. “We believe that precise administration of OpRegen cells to the back of the eye utilizing the Orbit SDS will lead to better dose control and an overall safer procedure, with an increased likelihood of positive clinical outcomes. In preparation for potential future commercialization, we also are introducing our new thaw-and-inject formulation, enabling rapid off-the-shelf administration of RPE cells upon thawing, which we believe will streamline the use of OpRegen by retinal surgeons.”