Neurotech Secures FDA Approval for Encelto, Pioneering Cell Therapy Implant for Rare Eye Disorder

Published: 13 Mar 2025

Author: Precedence Research

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Neurotech Pharmaceuticals, the first company to gain FDA approval for encapsulated cell therapy implant, Encelto. This is approved for treatment against a rare neurodegenerative eye disease called macular telangiectasia (MacTel) type 2. MacTel type 2 is a progressive retinal disease affecting central vision with onset generally in middle-aged adults, where abnormal dilatation of small blood vessels in the macula leads to swelling and thickening of the macula and progressive visual decline. The disease affects both eyes but usually to different extents. It has no previously approved treatment; hence, this new approval will certainly bring with it hope in possibly slowing the progression of the disease and preserving vision for those affected. This is a great advance in ophthalmology.

How Encelto Works: A Revolution in Cell Therapy

Neurotech developed Encelto, a cell-based gene therapy delivery system for MacTel type 2 disease. This implant is a semipermeable capsule filled with genetically modified retinal pigment epithelium cells that produce and release ciliary neurotrophic factor (CNTF) a neuroprotective protein believed to slow down the progression of this disease. The capsule allows for the delivery of nutrients straight to the cells while the CNTF is released directly to the retina. FDA approval of Encelto relied on two clinical studies that proved its efficacy in slowing the disease of macular telangiectasia type 2 as well as a marked decrease in photoreceptor loss which is considered a strong measure of disease progression rate.

A Historic Moment for the MacTel Community

The FDA has now approved Encelto, the first-ever treatment for the kind of visually threatening macular degeneration referred to as MacTel type 2. This is a really important event for the MacTel community because it presents the treatment gap in retinal disease. Encelto will deliver drugs in a minimally invasive procedure over a long time with the added benefit of preservation of photoreceptors. Thus, it becomes the first FDA-approved treatment for MacTel type 2 a gap-filler and initiator for further innovation in retinal disease treatments. The implant is surgically placed in a single procedure thereby reducing the treatment burden on the patients. These are a few reasons that make Encelto a pen-building convenient and effective solution for MacTel patients but also showcase the expanded potential of encapsulated cell therapy for the treatment of multiple chronic eye conditions.

Neurotech’s Commercial Plans and Market Launch

It's quite a big day for the biotech company to celebrate its launch commercially in the United States. By June 2025, Encelto will be ready. With this, Neurotech successfully commercializes its first product and showcases the utility of its encapsulated cell therapy platform for future ophthalmic and regenerative medicine inventions. The company has been investigating further potential indications of its proprietary platform for other retinal diseases—specifically photoreceptor function and neurodegeneration. Most importantly, FDA approval for Encelto makes way for future breakthroughs in the treatment of retinal disease for an area that continues to seek out next-generation treatments such as encapsulated cell technology. Such an introduction is expected to tease the audience with its impact on patients and healthcare providers.