CUMBERLAND, R.I.—The U.S. Food and Drug Administration has determined that the Biologic License Application conducted by Neurotech Pharmaceuticals Inc., for NT-501, an investigational encapsulated cell therapy for the treatment of MacTel, is sufficiently complete to permit a substantive review, according to an announcement from Neurotech. MacTel is a progressive, neurodegenerative disease of the retina that results in the deterioration of central vision, significantly impacting patients' quality of life. NT-501 is an ocular implant designed to deliver sustained therapeutic doses of ciliary neurotrophic factor directly to the retina to slow the progression of the disease, Neurotech said.

The application has a prescription drug user fee act (PDUFA) goal date of December 17, 2024, the company stated. Neurotech specializes in sustained drug delivery for chronic retinal diseases.

“This is a significant achievement for Neurotech,” said Richard Small, chief executive officer. “I would like to express my gratitude to our employees for reaching this important milestone.”