FDA approves Encelto for macular telangiectasia type 2

Key takeaways:

• Encelto is the first FDA-approved treatment for macular telangiectasia type 2.
• The cell therapy slows the loss of macular photoreceptors through continuous delivery of ciliary neurotrophic factor.

Editor’s note: This is a developing news story. Please check back soon for updates.

The FDA approved Encelto, an encapsulated cell therapy, for the treatment of macular telangiectasia type 2, according to a press release from Neurotech Pharmaceuticals.

The decision was supported by positive data from two phase 3 trials in which Encelto (revakinagene taroretcel-lwey) slowed the loss of macular photoreceptors in patients with macular telangiectasia (MacTel) over 24 months. As Healio previously reported, the cell therapy, previously known as NT-501, met the primary outcomes of both phase 3 trials.

Encelto, the first FDA-approved treatment for MacTel, is designed to continually deliver doses of ciliary neurotrophic factor to the retina to slow disease progression, according to the release.

“Today marks an extraordinary milestone for patients, the retina community and Neurotech,” Richard Small, CEO of Neurotech, said in the release. “I would like to express my gratitude to clinical study participants, clinical investigators and their teams, and the entire Neurotech organization who have helped make this a reality.”

Neurotech expects Encelto to be available in the U.S. starting in June.

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