New Wet AMD Drug Approved in the United States
November 21, 2011 - A new wet AMD drug, known as EYLEA® (generic name: aflibercept), has just been approved by the Food and Drug Administration (FDA) in the United States. The drug was developed by a partnership between Regeneron Pharmaceuticals, Inc. and Bayer HealthCare and will be sold in the US by Regeneron. Canadian approval of the drug is likely within the next year where it will be marketed by Bayer HealthCare.
EYLEA® works in a similar way to the currently approved wet AMD drug Lucentis® (generic name: ranibizumab) and to Avastin (genetic name: bevacizumab), which is often used off-label to treat wet AMD. In all three cases, the drugs are injected into the eye, where they inhibit the growth of abnormal blood vessels under the retina and prevent bleeding that can cause rapid vision loss. All three drugs are in a class of drug called anti-VEGF agents. See this video created by Regeneron to learn more about anti-VEGF drugs.
Research studies of EYLEA® used the name VEGF Trap-Eye. These studies (known as VIEW-1 and VIEW-2) suggest that EYLEA® may require less frequent doses than other approved wet AMD therapies following a three month introductory phase where the drug is given monthly. In the major studies of this drug, EYLEA® was injected once a month for the first 3 months and then bimonthly – a schedule that was equal in efficacy to monthly Lucentis®. For more about the results of these research studies, see this previous FFB news report on the drug.
Adverse effects of EYLEA® in these trials were very similar to other anti-VEGF drugs. The most common adverse reactions (frequency of 5% or more) in patients receiving EYLEA® were bleeding in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. The likelihood of other more serious complications, including systemic events like heart attack or stroke, are low – and similar to other approved drugs.
“EYLEA offers the potential of achieving the efficacy we’ve come to expect from current anti-VEGF agents, but with less frequent injections,” says Dr. Jeffrey Heier MD, a clinical ophthalmologist and retinal specialist from Boston who chaired the Steering Committee for the VIEW 1 trial. “This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers.”