Committee recommends AMD drug for FDA approval

US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has recommended approval of Eylea for the treatment of wet age-related macular degeneration.

The drug, more commonly known as VEGF-TrapEye, is used every eight weeks following three initial doses every four weeks. The decision is based on the results of two phase 3 clinical trials, View 1 and View 2.

These studies found that all regimens of Eylea (aflibercept ophthalmic solution) met the primary endpoint of statistical non-inferiority with Lucentis (ranibizumab) 0.5mg monthly dosing, the current standard of care.

The drug maintained or improved vision over 52 weeks at a rate comparable to ranibizumab.