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FDA approves ReNeuron’s cryopreserved formulation of retinal stem cell therapy candidate

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The FDA has approved the cryopreserved formulation of ReNeuron Group’s human retinal progenitor cell therapeutic candidate, according to a company press release.

Patients with retinitis pigmentosa are now being treated with the formulation in a phase 1/2 clinical trial. The formulation allows cells to be frozen for shipping and storage and thawed for clinical use, increasing shelf life and lowering cost, the release said.

“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 programs,” Olav Hellebø, CEO of ReNeuron, said in the release. “This is a further significant milestone for ReNeuron, enabling an expansion of our clinical programs in ophthalmology as well as providing ReNeuron with a significant commercial advantage in terms of prospective cost of goods and ease of use of a retinal disease therapy.”

The company plans to file an application with the FDA to expand the phase 2 portion of the phase 1/2 trial from six patients to 20 patients. It also plans to file an application for a new phase 2 trial for patients with cone-rod dystrophy.