FDA approves Eylea for treatment of wet AMD

Issue: December 25, 2011

TARRYTOWN, N.Y. — The U.S. Food and Drug Administration has approved the use of Eylea to treat neovascular age-related macular degeneration. Regeneron hopes to bring the anti-VEGF therapy to the market within days, according to a company press release.

Eylea (aflibercept), also known as VEGF Trap-Eye, was under a priority review by the FDA, a classification offered when a drug may offer major advances in treatment or for a condition that has no adequate therapy, according to Regeneron.

"Eylea is an important new treatment option for adults with wet AMD," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a FDA press release. "It is a potentially blinding disease, and the availability of new treatment options is important."

The approval followed a pair of phase 3 clinical studies, VIEW 1 and VIEW 2, of almost 2,500 patients that determined injection every 2 months, after three initial monthly injections, maintained or improved visual acuity in a manner clinically equivalent to monthly doses of Lucentis (ranibizumab, Genentech), according to the company 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," Jeffrey Heier, MD, a clinical ophthalmologist and retina 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 the company release. "This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers."

The most common side effects from the treatment are eye pain, conjunctival hemorrhage, vitreous floaters, cataract and increased IOP, according to the FDA.

Eylea (aflibercept, Regeneron Pharmaceuticals) received FDA approval in November 2011 for the treatment of neovascular AMD. The prescribing information allowed a flexible dosing strategy that included either a monthly dosing regimen for 3 months followed by every 8-week dosing or a strictly monthly dosing regimen. The ability to still administer the drug monthly will be beneficial for our patients with the most recalcitrant lesions. It is estimated that approximately 15% to 20% of patients receiving monthly anti-VEGF therapy with either bevacizumab or ranibizumab still have signs of disease activity (subretinal fluid, intraretinal fluid, macular hemorrhage, or increased pigment epithelial detachment size) despite the regular monthly dosing approach. Although leakage is present, visual acuity may still be quite good compared with baseline; therefore, it would be inappropriate to call these patients bevacizumab or ranibizumab “failures.” Similarly, however, it would be inappropriate to label these patients as excellent responders. I like to refer to these patients as suboptimal anti-VEGF responders. It is this first cohort of patients who are receiving monthly bevacizumab or ranibizumab and who still show signs of lesion activity that will be the first patients who I will switch to aflibercept. The clinical trial data over the first 2 years of therapy with aflibercept vs. ranibizumab do not show a tremendous visual acuity or dosing advantage for aflibercept, so only our clinical experience in the first year of aflibercept availability will tell us whether there is a distinct advantage of aflibercept over bevacizumab or ranibizumab for the suboptimal responder cohort. Perhaps a favorable experience with this group of patients will drive increased aflibercept utilization for other neovascular AMD patients as well.

– Andrew A. Moshfeghi, MD, MBA
OSN Retina/Vitreous Board Member
Disclosure: Dr. Moshfeghi is a consultant to Allergan, Alcon, Genentech/Roche, Alimera and Zeiss. He previously served as a speaker on behalf of Genentech.