The US FDA has granted Fast Track designation for NT-501 or Renexus for the treatment of macular telangiectasia type 2 (MacTel), Neurotech Pharmaceuticals said.
Renexus is a novel cell-based drug delivery system. Human-derived cells encapsulated in a semipermeable hollow fibre membrane device release ciliary neurotrophic factor (CNTF) demonstrated to reduce photoreceptor cell loss in animal models of retinal degeneration.
The implanted Renexus device results in sustained delivery of CNTF localized to the retina, the light-sensing tissue in the back of the eye. MacTel is a rare macular degenerative disease typically diagnosed in middle age. Patients rarely experience total vision loss, but the disease nonetheless has a significant impact, through visual loss, on a patient’s quality of life.
Based on the positive phase 2 results, two parallel phase 3 studies were initiated.
Macular telangiectasia (MacTel), or idiopathic juxtafoveal macular telangiectasia, is a rare neurodegenerative disease with characteristic alterations of the retinal vasculature and localized retinal degeneration.