FDA approves new therapy for macular degeneration
The U.S. Food and Drug Administration (FDA) has approved Eylea (aflibercept) for treating wet, age-related macular degeneration (AMD). The eye condition, which can include the growth of abnormal blood vessels that leak fluid into the retina, can gradually destroy the central vision field.
Edward Cox, M.D., an FDA director, says approval of Eylea provides "an important new treatment option" for those with wet AMD. According to the FDA, the disorder is a leading cause of vision loss among people age 60 and older.
The prescription drug is injected into the eye by an ophthalmologist either every four or eight weeks. It was determined to be safe and effective in maintaining or improving visual acuity on the basis of two clinical trials involving 2,412 adults with wet AMD.
The most common side effects reported by patients during the trials included eye pain, blood at the injection site, floating spots in the field of vision, clouding of the eye lens, and increased eye pressure. The FDA notes that Eylea is not suitable for persons suffering from eye infections or inflammation.
Between 2000 and 2006 the FDA approved several other injectable drugs to treat wet AMD, including Visudyne (verteporfin), Macugen (pegaptanib sodium) and Lucentis (ranibizumab).