Eye News: FDA Approves Stem Cell Trial for Macular Degeneration
FDA Approves Stem Cell Trial for Macular Degeneration
(January 3, 2011.)
Advanced Cell Technology announced on January 3rd it had won U.S. Food and Drug Administration approval to test human embryonic stem cells for treating dry age-related macular degeneration, a common cause of vision loss.
It is only the second FDA-approved trial for ACT's stem cell product and the third for the controversial and powerful stem cells.
ACT said it would start recruiting patients with dry age-related macular degeneration using retinal pigment epithelial, or RPE cells, which ACT makes from human embryonic stem cells.
In October 2010, Geron Corp enrolled the first patient in the first ever approved study of human embryonic stem cells, to treat people whose spinal cords have been crushed.
In November 2010, ACT won FDA approval for the second human trial of human embryonic stem cells to treat people with a progressive form of blindness called Stargardt's macular dystrophy.
There are several treatment options for "wet" age-related macular degeneration including laser surgery, photodynamic therapy and injections of drugs directly into the eye that block formation of abnormal vessels. These include anti-VEGF (Vascular Endothelial Growth Factor) drugs such as Lucentis and Avastin. Taking a specific combination of vitamins and zinc can reduce the risk of vision loss from both dry and wet AMD and perhaps slow its progression (Bausch & Lomb Preservision).
There are no good treatments for advanced cases of dry AMD, which causes an estimated 85% of cases of macular degeneration, according to the U.S. National Eye Institute.