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FDA Approves First Eye Implant to Preserve Vision in Rare Macular Telangiectasia

Delivering continuous CNTF to protect retinal cells, the implanted device is slated to reach U.S. patients in June 2025.

Image
MacTel affects the central part of the retina, which is essential for sharp, detailed vision. Credit: Neuroscience News

Overview

  • ENCELTO (revakinagene taroretcel-lwey) secured FDA approval on March 6, 2025 as the first treatment for macular telangiectasia type 2, a disease that progressively impairs central vision.
  • The implant uses genetically engineered retinal pigment epithelial cells to secrete ciliary neurotrophic factor, supporting photoreceptor survival and delaying degeneration.
  • Two phase 3 studies demonstrated slowed loss of light-sensing retinal cells over 24 months, and explanted devices maintained therapeutic CNTF levels after 14.5 years.
  • Development stemmed from a collaboration between Scripps Research, the Lowy Medical Research Institute and Neurotech Pharmaceuticals, driven by a Lowy family member’s MacTel diagnosis.
  • Investigators are now evaluating ENCELTO’s potential in treating other neurovascular conditions such as glaucoma and age-related macular degeneration.