Neurotech Pharmaceuticals, Inc. has announced FDA approval of ENCELTO (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel). ENCELTO is the First and Only FDA-approved first and only 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. ENCELTO 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. ENCELTO is the first and only FDA-approved treatment available for MacTel.
The approval was based on results from two phase 3 trials which demonstrated that after placement of the implant ENCELTO significantly slowed the loss of macular photoreceptors in MacTel patients over 24 months. ENCELTO is expected to be available in the United States for patients starting in June of 2025.
“I have seen the impact that MacTel can have on patients and their quality of life,” said Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, Houston, TX, a clinical investigator. “Now with an FDA-approved treatment, I am confident that ENCELTO will be able to meaningfully slow disease progression for many patients affected by MacTel, allowing them the opportunity to preserve more functional vision over time.”
SOURCE: Press Release