US FDA Approves Neurotech’s Cell Therapy Implant for MacTel

Neurotech Pharmaceuticals announced March 6 that the US FDA had approved Encelto, an encapsulated cell therapy implant to treat macular telangiectasia (MacTel) type 2.

It’s the first FDA-approved treatment for the disease, the company said.

MacTel is a slowly progressing disease that causes loss of central vision as capillaries around the fovea widen and leak. The leaking blood pools in the macula, impairing vision and damaging photoreceptors. Development of scar tissue on the macula can further impede central vision.

The approval was based on results from two Phase III trials that showed Encelto significantly slowed the loss of macular photoreceptors in MacTel patients over 24 months.

Encelto (revakinagene taroretcel) is indicated for one-time implantation in the vitreous, anchored to the sclera. The implant is a tiny hollow cylindrical membrane that encapsulates human epithelial cells genetically engineered to continuously produce ciliary neurotropic factor (CNTF). CNTF is a potent neuroprotective protein that promotes the survival and maintenance of photoreceptors.

The cells can’t escape the implant, but nutrients can enter the implant, and therapeutic factors produced by the cells can leave, Neurotech says.

Neurotech, of Cumberland, Rhode Island, said Encelto should be available in the US starting in June.