Cryopreserved formulation of retinal stem cell therapy approved by FDA

ReNeuron Group has announced that the FDA has approved the cryopreserved formulation of its human retinal progenitor cell (hRPC) therapeutic candidate, which enables it to be frozen for shipping and storage and thawed at the point of clinical use.

This freeze-thaw modality improves shelf life of the product and hence will reduce the prospective cost and facilitate transportation. The hRPC formulation has also expanded the company’s clinical programme in ophthalmology, with an application to expand the current Phase II element of the clinical trial for the treatment of retinitis pigmentosa (RP) currently with the FDA.

“We are delighted that the FDA has approved the use of the cryopreserved formulation of our hRPC retinal cell therapy candidate in our ongoing clinical development programmes,” said Olav Hellebø, chief executive officer of ReNeuron. “This is a further significant milestone for ReNeuron, enabling an expansion of our clinical programmes in ophthalmology as well as providing ReNeuron with a significant commercial advantage in terms of prospective cost of goods and ease of use of retinal disease therapy.”

ReNeuron Group is a clinical-stage cell therapy development company, based in the UK.