ENCELTO™ Approved by the FDA for the Treatment of Macular Telangiectasia Type 2 (MacTel)
Neurotech Pharmaceuticals, a private biotech company, announced that the U.S. Food and Drug Administration (FDA), has approved ENCELTO™ (revakinagene taroretcel-lwey) for the treatmentof Macular Telangiectasia type 2 (MacTel). ENCELTO is the First and Only FDA-approved Treatment for MacTel.
MacTel is a neurodegenerative disease of the retina in adults that causes progressive and irreversible vision loss, significantly impacting patients' quality of life. ENCELTOTM utilizes an encapsulated cell therapy technology designed to continually deliver therapeutic doses of ciliary neurotrophic factor (CNTF) to the retina to assist in slowing the progression of the disease.
The approval was based on results from two phase 3 trials which demonstrated that after placement, of the implant, ENCELTOTM significantly slowed the loss of macular photoreceptors in MacTel patients over 24 months.
ENCELTOTM is expected to be available in the United States for patients starting in June of 2025.
About Macular Telangiectasia Type 2 (MacTel)
Macular Telangiectasia Type 2 (MacTel), or idiopathic macular telangiectasia type 2, is a bilateral, neurodegenerative disease in adults with characteristic localized retinal degeneration, a group of diseases that cause the gradual loss of cells in the retina, resulting in vision loss and secondary alterations of the retinal vasculature, the network of blood vessels that supplies oxygen and nutrients to the retina.1
About Encapsulated Cell Therapy (ECT)
Neurotech’s ECT platform is a cell-based gene therapy delivery system designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases. This versatile platform consists of a small, semi-permeable capsule containing proprietary allogeneic retinal pigment epithelium (RPE) cells genetically engineered to produce specific therapeutic proteins for targeted disease treatment. The capsule is surgically implanted. Once in place, the capsule's semi-permeable exterior membrane allows essential nutrients to enter, while also permitting the therapeutic proteins to exit into the eye where they can travel to the retina located at the back of the eye. The exterior membrane protects the encapsulated RPE cells from the host's immune system, contributing to their survival and functionality over time.
Source: Neurotech Pharmaceuticals