Neurotech Pharmaceuticals receives priority review of BLA for NT-501 for treatment of MacTel

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A priority review has been granted with a PDUFA goal date set for December 17, 2024.

(Image Credit: AdobeStock/BillionPhotos.com)

(Image Credit: AdobeStock/BillionPhotos.com)

Neurotech Pharmaceuticals Inc announced the FDA has determined that the Biologic License Application (BLA) for NT-501, an investigational encapsulated cell therapy for the treatment of idiopathic juxtafoveal macular telangiectasia (MacTel), is sufficiently complete to permit a substantive review.

According to a news release, the application has a prescription drug user fee act (PDUFA) goal date of December 17, 2024.1

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

The company noted in the news release that NT-501, 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, leverages its Encapsulated Cell Therapy (ECT) platform to deliver CNTF for the treatment of chronic retinal diseases, such as MacTel.

CNTF is a potent 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.1

MacTel is a progressive, neurodegenerative disease of the retina that results in the deterioration of central vision, significantly impacting patients' quality of life.

Reference:
  1. Neurotech Pharmaceuticals, Inc. Receives Priority Review of Biologics License Application (BLA) for NT-501 (Revakinagene Taroretcel) as a Treatment for Macular Telangiectasia Type 2 (MacTel).; 2024. Accessed June 20, 2024. https://www.neurotechpharmaceuticals.com/wp-content/uploads/Neurotech_Press-Release_BLA_FINAL.pdf
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