FDA OKs Aflibercept (Eylea) for Diabetic Macular Edema

July 30, 2014

The US Food and Drug Administration (FDA) has approved aflibercept (Eylea, Regeneron Pharmaceuticals) injection solution to treat visual impairment caused by diabetic macular edema (DME), the manufacturer announced yesterday.

The new indication for aflibercept joins 2 others: for neovascular (wet) age-related macular degeneration and for macular edema after central retinal vein occlusion.

Aflibercept decreases the abnormal growth of blood vessels as well as leakage and edema in the retina by blocking vascular endothelial growth factor (VEGF) A, a trigger for angiogenesis. It also neutralizes a related angiogenic protein called placental growth factor.

The drug is marketed as a single, 2-mg intravitreal injection regardless of indication. For DME, clinicians should inject aflibercept in the eye every month for 5 months and then switch to every other month. Regeneron noted in a news release that aflibercept is the first VEGF inhibitor that can be taken for less than once a month for DME.

The FDA has determined that aflibercept is safe and effective on the basis of clinical trials that compared patients taking the drug with a control group receiving macular laser photocoagulation, according to Regeneron. Patients treated with aflibercept were able to read, on average, roughly 2 additional lines on an eye chart, whereas the control group experienced essentially no improvement. The most common ocular adverse events associated with the drug include conjunctival hemorrhage, eye pain, cataracts, and vitreous floaters. Hypertension and nasopharyngitis were among the most common nonocular adverse events.

The FDA's decision to approve aflibercept for DME comes less than a month after the European Medicines Agency recommended the drug for that indication. Aflibercept also is approved for neovascular (wet) age-related macular degeneration and macular edema after central retinal vein occlusion in the European Union, where it is marketed by Bayer Healthcare.

Regeneron and Bayer Healthcare have asked their respective drug regulators to approve aflibercept for yet another indication: vision impairment caused by macular edema secondary to branch retinal vein occlusion.


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