FDA Approves Neurotech's Encelto as First and Only FDA-Approved Treatment for MacTel

Neurotech Pharmaceuticals announced that the FDA has approved Encelto (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel).

MacTel is a neurodegenerative disease of the retina in adults that causes progressive and irreversible vision loss. Encelto utilizes an 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. Encelto is the first and only FDA-approved treatment available for MacTel.

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 24 months.

“Today marks an extraordinary milestone for patients, the retina community, and Neurotech,” Richard Small, Chief Executive Officer, said in a company news 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.”

“I have seen the impact that MacTel can have on patients and their quality of life,” said Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, Houston, a clinical investigator. “Now with an FDA-approved treatment, I am confident that Encelto will be able to meaningfully slow disease progression for many patients affected by MacTel, allowing them the opportunity to preserve more functional vision over time.”

Encelto is expected to be available in the United States for patients starting in June of 2025. In an interview with EyewireTV, Mr. Small said the company is still having internal discussions regarding pricing. He added that the company has been interacting with payers for almost 2 years.