The American regulator has approved a cryopreserved formulation of ReNeuron Group Plc’s (LON:RENE) cell therapy for degenerative diseases of the retina.
The US Food & Drug Administration (FDA) green light means its human retinal progenitor cells (hRPC) can be frozen for shipping and storage and thawed at the point of use.
“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 a retinal disease therapy," said chief executive Olav Hellebø.
Clinical programme to expand
Researchers have started treating patients with the new formulation in a US phase-I/II study clinical trial in patients with retinitis pigmentosa, a degenerative eye disease.
As mentioned above the new cryopreserved formulation will allow an expansion of ReNeuron's clinical programmes in ophthalmology.
The firm will shortly file an application with the FDA to expand the phase-II element of the ongoing phase-I/II clinical trial in retinitis pigmentosa from six to 20 patients.
This is designed to provide the depth and quality of data that, if positive, will allow progression to a phase-II/III pivotal study.
ReNeuron will also file an application to start a new US phase-II clinical trial later this year in patients with cone-rod dystrophy (another degenerative eye condition), to be conducted alongside the phase-II part of the ongoing retinitis pigmentosa clinical trial.