Neurotech Receives Priority Review of BLA for NT-501 as a Treatment for Macular Telangiectasia Type 2 (MacTel)

The FDA has granted priority review of Neurotech Pharmaceuticals's biologic license application (BLA) for NT-501 (revakinagene taroretcel), an investigational encapsulated cell therapy for the treatment of Macular Telangiectasia Type 2 (MacTel). The designation means the agency determined the application is sufficiently complete to permit a review and aims to taken action with 6 months, compared to 10 months for standard review.

The application has a prescription drug user fee act (PDUFA) goal date of December 17, 2024.

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

MacTel is a progressive, neurodegenerative disease of the retina that results in the deterioration of central vision. 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 the disease.

NT-501 leverages the company's Encapsulated Cell Therapy (ECT) platform to deliver CNTF for the treatment of chronic retinal diseases, such as MacTel. CNTF is a neuroprotective protein that promotes the survival and maintenance of photoreceptors. This targeted therapy provides sustained delivery of CNTF, aiming to slow retinal degeneration and potentially improve long-term visual outcomes for patients.