The Food and Drug Administration announced its approval of the implant ENCELTO as the first treatment for macular telangiectasia (MacTecl).
MacTel can affect one or both eyes and can either be congenital or acquired. The disease causes abnormalities of the capillaries of the fovea or perifoveal area of the eye, which causes the nerve cells of the retina to start to die off.
ENCELTO is implanted at the back of the eye and the device releases a protein known as neutrotrophic factor, which protects neurons in the retina.
Clinical trial results demonstrated that the device caused a 55% reduction in the rate of retinal cell degeneration in one trial and almost a 31% reduction in the second trial. Additional tests showed a marked slowing in loss of visual function and researchers found that the data from both trials showed statistically significant results.
