The US Food and Drug Administration (FDA) has 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.

NT-501 utilizes Neurotech’s encapsulated cell therapy (ECT) 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 (CNTF), 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 a press release. The FDA’s original PDUFA goal date for NT-501 was December 17, 2024.