The FDA extended its decision deadline on Neurotech Pharmaceuticals’s biologics license application (BLA) for NT-501, a treatment for macular telangiectasia Type 2 (MacTel). The new prescription drug user fee act (PDUFA) target date is March 18, 2025, allowing time for the agency to assess additional data recently submitted by Neurotech, the company said in a press release. 

NT-501 utilizes Neurotech’s encapsulated cell therapy platform, which provides continuous, targeted drug delivery through a small, surgically implanted capsule. The capsule contains genetically engineered retinal cells that produce ciliary neurotrophic factor, a protein aimed at protecting photoreceptors in the retina from degeneration, offering potential long-term visual benefits for patients with MacTel.

“We are committed to providing the FDA any information needed to complete the review of the NT-501 BLA,” said Richard Small, Neurotech’s chief executive officer, in the press release. The FDA’s original PDUFA goal date for NT-501 was Dec. 17, 2024.