FDA Approves Eylea for Eye Disorder in Older People
SILVER SPRING, Md., Nov. 18, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.
AMD gradually destroys a person's sharp, central vision. It affects the macula, the part of the eye that allows people to see fine detail needed to do daily tasks such as reading and driving.
There are two forms of AMD, a wet form and a dry form. The wet form of AMD includes the growth of abnormal blood vessels. The blood vessels can leak fluid into the central part of the retina, also known as the macula. When fluid leaks into the macula, the macula thickens and vision loss occurs. An early symptom of wet AMD occurs when straight lines appear to be wavy.
"Eylea is an important new treatment option for adults with wet AMD," said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "It is a potentially blinding disease and the availability of new treatment options is important."
The safety and effectiveness of Eylea was evaluated in two clinical trials involving 2,412 adult patients. People in the study received either Eylea or Lucentis (ranibizumab injection). The primary endpoint in each study was a patient's clearness of vision (visual acuity) after one year of treatment.
Eylea is injected into the eye either every four weeks or every eight weeks by an ophthalmologist. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity.
The most commonly reported side effects in patients receiving Eylea included eye pain, blood at the injection site (conjunctival hemorrhage), the appearance of