BioTime has entered into a research and option agreement with Orbit Biomedical to access new device for the sub-retinal delivery of OpRegen cells for the treatment of dry age-related macular degeneration (dry-AMD).
Under the deal terms, the companies will partner on the use of Orbit Biomedical’s injection technology to deliver OpRegen to treat dry-AMD.
Orbit Biomedical, founded last year in London, focuses on the development of surgical device and training platform to deliver cell and gene therapies to sub-retinal space.
Under the terms of the agreement, which will last for 12 months, the two companies plan to investigate the safety and utility of Orbit Biomedical’s surgical delivery technology in the ongoing Phase I/II clinical study of OpRegen in the reatment of dry-AMD.
Traditionally, the sub-retinal space can be accessed vitrectomy, where vitreous, the gel-like substance that fills the eye is removed, followed by an injection into the eye and through the retina.
OpRegen is a retinal pigment epithelium transplant therapy in phase I/IIa development for treating dry-AMD.
OpRegen has suspended retinal pigment epithelial (RPE) cells delivered subretinally as an intraocular injection. RPE cells are the essential components of the back lining of the retina and function to help nourish the retina including photoreceptors.
It has been granted fast track designation by the US Food and Drug Administration (FDA). It is a registered trademark of Cell Cure Neurosciences, a subsidiary of BioTime.
The injection system of Orbit Biomedical is claimed to have been designed to precisely and consistently deliver therapeutics to the sub-retinal space via a suprachoroidal route, where the need for vitrectomy and perforation of the retina is avoided.
BioTime CEO Brian Culley said: “Orbit Biomedical’s specifically-designed device offers surgeons an innovative solution for the delivery of therapies to the sub-retinal space, a well-known challenge in ophthalmology. This alliance gives us the opportunity to evaluate the Orbit Biomedical technology early in the clinical development process of OpRegen and also provides BioTime with an option to negotiate an exclusive license for the commercial use of the device with OpRegen for the treatment of dry-AMD.
“We believe access to the Orbit device has the potential to meaningfully enhance the clinical profile of OpRegen to further benefit dry-AMD patients.”