BioTime has announced the dosing of the first patient in its ongoing Phase I/IIa clinical study for the treatment of dry age-related macular degeneration that causes adult blindness in the developed world.
BioTime said that it has dosed the first patent with the Orbit Subretinal Delivery System (Orbit SDS) along with with a new Thaw-and-Inject formulation of OpRegen, a retinal pigment epithelium (RPE) transplant therapy.
The Phase I/IIa study is primarily aimed at evaluating the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events (AEs).
In addition, the study is also aimed at evaluating the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
OpRegen is a retinal pigment epithelium (RPE) transplant therapy comprising a suspension of RPE cells delivered subretinally as an intraocular injection, used in Phase I/IIa development for the treatment of dry-AMD.
BioTime said that OpRegen has secured Fast Track designation from the US Food and Drug Administration (FDA), and its RPE cells are crucial components of the back lining of the retina and function to help nurture the retina including photoreceptors.
The Orbit SDS is set to help surgeons deliver therapies to the retina with precision and accuracy.
Surgeons traditionally perform a vitrectomy and remove the gel-like substance filled in the eye, to deliver a therapy to the retina. The therapy is then injected into the eye through a process called a retinotomy.
The FDA 510K approved Orbit SDS avoids the need for vitrectomy and perforation of the retina, to simplify surgical procedures and make the administration safe and consistent.
BioTime Brian chief executive officer M Culley said: “We are excited to be evaluating the FDA-cleared Orbit SDS in the next six patients of our Phase I/IIa study. 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.”