FDA approves aflibercept for wet AMD

Tarrytown, NY-The FDA has approved the recombinant fusion protein aflibercept (Eylea, also known as VEGF Trap-Eye, Regeneron Pharmaceuticals) for the treatment of patients with neovascular age-related macular degeneration (AMD). The approved dosage of aflibercept for wet AMD is 2 mg given every 4 weeks for the first 12 weeks, followed by 2 mg every 8 weeks.

The approval of aflibercept was granted under a priority review, a designation that is given to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.

The approval was based on the results of two phase III clinical studies. In these studies, aflibercept dosed every 8 weeks following three initial monthly injections, was clinically equivalent to the standard of care, ranibizumab injection (Lucentis, Genentech), dosed every 4 weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks. The adverse event profile of aflibercept was similar to that of ranibizumab, according to the company.

“The approval of [aflibercept] offers a much-needed new treatment option for patients with wet AMD,” said Jeffrey Heier, MD, a clinical ophthalmologist and retinal specialist at Ophthalmic Consultants of Boston, assistant professor of ophthalmology at Tufts School of Medicine, Boston, and chairman of the steering committee for the VIEW 1 trial, one of the clinical trails on which the FDA’s approval was based.

“[Aflibercept] offers the potential of achieving the efficacy we’ve come to expect from current anti-vascular endothelial growth factor agents, but with less frequent injections and no monitoring requirements,” Dr. Heier said. “This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers.”

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