FDA grants priority review of NT-501 for macular telangiectasia type 2
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The FDA granted priority review of the biologics license application for NT-501 as a treatment for macular telangiectasia type 2, according to a press release from Neurotech Pharmaceuticals.
The application for the investigational encapsulated cell therapy has been given a PDUFA goal date of Dec. 17.
The ocular implant is designed to deliver sustained therapeutic doses of ciliary neurotrophic factor to the retina. Healio previously reported that it demonstrated statistically significant results for slowing the progression of macular telangiectasia in two phase 3 registration studies.
“This is a significant achievement for Neurotech,” Richard Small, CEO of Neurotech, said in the release. “I would like to express my gratitude to our employees for reaching this important milestone.”