CUMBERLAND, R.I. — Neurotech Pharmaceuticals has completed the first commercial manufacturing, shipment, and surgical procedure for ENCELTO (revakinagene taroretcel-lwey), the first and only FDA-approved treatment for idiopathic Macular Telangiectasia Type 2 (MacTel). The therapy is an encapsulated cell-based gene treatment designed to slow disease progression in adults.
“This is a huge milestone for people living with MacTel. For the first time, there is an FDA-approved treatment option that could change what is possible for patients,” said Richard Small, chief executive officer of Neurotech Pharmaceuticals. He added that the company had been working toward this outcome for years and that it was “incredibly exciting” to see it reach patients.
Charles C. Wykoff, M.D., Ph.D., of Retinal Consultants of Texas in Houston, performed the first ENCELTO procedure outside of a clinical trial. “For the first time, we can offer a valuable and durable treatment option for patients, one that slows their loss of photoreceptors and maintains more visual function over time,” Wykoff said. He noted that MacTel often causes gradual, progressive vision decline, making the availability of an approved therapy “exciting” for both physicians and patients.
MacTel is a bilateral, neurodegenerative eye disease in adults characterized by localized retinal degeneration and gradual loss of retinal cells. The condition leads to vision loss and changes in the retinal vasculature, which supplies oxygen and nutrients to the retina.