FDA Approves Lucentis for Wet AMD

Genentech has announced that the U.S. Food and Drug Administration (FDA) has approved Lucentis™ for the treatment of wet age-related macular degeneration (AMD).

“This is great news for the millions of older Americans at risk of losing their vision to wet AMD. People affected by wet AMD have had few alternatives,” says Stephen Rose, Ph.D., Chief Research Officer, Foundation Fighting Blindness “Lucentis is not only a new option, it appears to be safe and highly effective.”

Two-year results from the MARINA study showed that Lucentis halted vision loss in more than 90 percent of individuals with wet AMD. The treatment restored some vision in 33 percent of individuals receiving the higher of two doses (.5 mg). In the MARINA study, participants received Lucentis monthly via intravitreal injection (injection into the eye).

Lucentis is the second FDA-approved alternative in an emerging group of wet AMD treatments, which are said to be “anti-angiogenic,” a term given to treatments that inhibit or block the growth of vision-robbing blood vessels under the retina. Approved in late 2004, Macugen® was the first FDA-approved anti-angiogenic treatment for wet AMD.

Lucentis works by inhibiting Vascular Endothelial Growth Factor-A (VEGF-A), a protein that is believed to play a major role in the development of leaky, vision-robbing blood vessels under the retina. Growth of these unhealthy blood vessels is the hallmark of wet AMD.

AMD is the leading cause of legal blindness in Americans who are 55 years of age or older. Approximately nine million people in the U.S. are affected by AMD. The number of people affected by AMD is expected to double by 2020, because of the aging of the Baby Boomer population.

AMD occurs in two forms: wet and dry. The wet form causes significantly more cases of severe vision loss than dry. However, people with dry AMD are at risk of developing the wet form.

The urgent mission of The Foundation Fighting Blindness is to drive the research that will provide preventions, treatments, and cures for people affected by retinitis pigmentosa, macular degeneration, Usher syndrome, and the entire spectrum of retinal degenerative diseases.