FDA approves aflibercept for patients with wet AMD

November 21, 2011

FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

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 2 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.

This approval was based upon the results of 2 phase 3 clinical studies. In these studies, Eylea dosed every 8 weeks, following 3 initial monthly injections, was clinically equivalent to the standard of care, ranibizumab injection (Lucentis) dosed every 4 weeks, as measured by the primary end point of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks. The most common adverse reactions (frequency of 5% or more) reported in patients receiving Eylea were blood at the injection site (conjunctival hemorrhage), eye pain, clouding of the eye lens (cataract), vitreous detachment, the appearance of floating spots in a person's vision (vitreous floaters), and increased intraocular pressure. The adverse event profile was similar to that seen with ranibizumab.

"The approval of Eylea offers a much needed new treatment option for patients with wet AMD," Jeffrey Heier, MD, a clinical ophthalmologist and retinal specialist at Ophthalmic Consultants of Boston, assistant professor of ophthalmology at Tufts School of Medicine, and chair of the Steering Committee for the VIEW 1 trial, said in a Regeneron press release. "Eylea offers the potential of achieving the efficacy we've come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements. This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers."

Eylea is injected into the eye either every 4 weeks or every 8 weeks by an ophthalmologist. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity.

Eylea should not be used in those who have an active eye infection or active ocular inflammation. Eylea has not been studied in pregnant women, so the treatment should be used only in pregnant women if the potential benefits of the treatment outweigh any potential risks. AMD does not occur in children and Eylea has not been studied in children.

Other FDA-approved treatment options for wet AMD include: Visudyne (verteporfin for injection) approved in 2000, Macugen (pegaptanib sodium injection) approved in 2004, and Lucentis (ranibizumab injection) approved in 2006.