Neurotech Review Extension on Retinal Disease BLA

FDA has extended by three months its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia Type 2 (MacTel). The extension is needed to review additional data provided by the company in response to recent requests from the agency. The revised user fee review action target date is 3/18.

Macular telangiectasia or idiopathic juxtafoveal macular telangiectasia Type 2 is described as a rare neurodegenerative disease that leads to localized retinal degeneration and secondary alterations of the retinal vasculature. It typically affects both eyes and causes a gradual deterioration in central vision, the company says.

NT-501 uses the company’s encapsulated cell therapy delivery system to deliver CNTF, a potent neuroprotective protein that promotes the survival and maintenance of photoreceptors, for treating chronic retinal diseases, such as MacTel, the company says.