Neurotech’s Encapsulated Cell Technology Receives FDA Approval for Treatment of MacTel

Neurotech, a biotechnology company developing therapies for chronic eye diseases, has received marketing approval from the US Food & Drug Administration (FDA) for ENCELTOÔ (revakinagene taroretcel-lwey) for the treatment of macular telangiectasia type 2 (MacTel).

At 24 months in two Phase 3 clinical trials, the treatment significantly slowed the loss of macular photoreceptors, the cells in the central retina that make vision possible. ENCELTO is expected to be available in the United States for patients starting in June 2025.

MacTel is usually bilateral and diagnosed in middle-aged adults. It’s characterized by the growth of leaky, damaging blood vessels as well as alterations to the retinal vasculature network. Risk factors for MacTel include hypertension and diabetes. MacTel can also run in families; the condition may have genetic risk factors.

ENCELTO is a tiny, semi-permeable capsule, the size of a rice grain, that’s implanted in the eye. Known as encapsulated cell technology (ECT), the capsule contains retinal pigment epithelial cells that are genetically engineered to secrete ciliary neurotrophic factor (CNTF), a protein that preserves photoreceptors.

The Foundation funded earlier preclinical and clinical studies of Neurotech’s ECT for the treatment of retinitis pigmentosa (RP) and dry age-related macular degeneration. The Foundation also funded preclinical studies of the ECT for diabetic macular edema and cystoid macular edema, secondary to RP. The ECT wasn’t ultimately approved by regulators for these conditions.