The FDA has determined that the biologic license application for Neurotech Pharmaceuticals’s investigational therapy NT-501 is sufficiently complete to permit a substantive review. NT-501 is an ocular implant designed to deliver sustained therapeutic doses of ciliary neurotrophic factor (CNTF) directly to the retina to slow the progression of macular telangiectasia (MacTel). The application has a prescription drug user fee act goal date of Dec. 17, 2024.

MacTel, or idiopathic juxtafoveal macular telangiectasia, is a rare neurodegenerative disease that typically affects both eyes and causes progressive deterioration in central vision. According to Neurotech, CNTF is a potent neuroprotective protein that promotes the survival and maintenance of photoreceptors. The company has completed Phase 3 trials of NT-501 in the United States and other countries, with data indicating that sustained delivery of CNTF can slow retinal degeneration and potentially improve long-term visual outcomes for patients with MacTel.

“This is a significant achievement for Neurotech,” said Richard Small, CEO, in a press release. “I would like to express my gratitude to our employees for reaching this important milestone.”