Neurotech cell therapy approved for rare eye disease

The U.S. FDA has approved Neurotech Pharmaceuticals’ Encelto (revakinagene taroretcel-lwey) for macular telangiectasia type 2 (MacTel), marking the first and only FDA approved treatment for the rare retinal disease.

MacTel is a neurodegenerative disease of the retina in adults that causes progressive and irreversible vision loss, significantly impacting patients' quality of life. Encelto utilizes a surgically implanted encapsulated cell therapy technology designed to continually deliver therapeutic doses of ciliary neurotrophic factor (CNTF) to the retina to assist in slowing the progression of the disease.

The approval was based on results from two phase 3 trials which demonstrated that after placement of the implant, Encelto significantly slowed the loss of macular photoreceptors in MacTel patients over the course of 24 months.

The nod came later than originally expected. Last summer, the FDA had granted Encelto priority review with a PDUFA goal date of December 17, 2024. Then in November, the agency pushed the goal date by three months to allow time to review additional data provided by Neurotech in response to the agency’s requests.

 Neurotech expects to make Encelto available to U.S. patients starting in June.