EU Panel OKs Aflibercept for Diabetic Macular Edema (Eylea)


June 30, 2014

A committee of the European Medicines Agency (EMA) on June 26 recommended market approval for aflibercept (Eylea, Bayer Pharma AG) injection solution to treat visual impairment caused by diabetic macular edema (DME).

This additional indication for aflibercept may be coming soon to the United States.

DME, a complication of diabetic retinopathy, represents the third indication for aflibercept that has received a green light from the EMA's Committee for Medicinal Products for Human Use (CHMP). The drug already had been cleared in the European Union (EU) for neovascular (wet) age-related macular degeneration and visual impairment caused by macular edema secondary to central retinal vein occlusion.

An engineered protein, aflibercept reduces the abnormal growth of blood vessels as well as leakage and edema in the retina by blocking vascular endothelial growth factor A, which triggers angiogenesis. It has the same neutralizing effect on a related protein called placental growth factor, which also stimulates the formation of blood vessels.

Aflibercept is injected into the eye. The recommended dose to treat DME is 2 mg, according to a press release issued by Bayer Healthcare.

Treatment begins with 1 monthly injection into the eye for 5 consecutive months. The frequency of injections then drops to 1 every 2 months. After the first 12 months of treatment, injections can be spaced out even more, "based on visual and anatomic outcomes," Bayer Healthcare said.

The most frequent adverse events in clinical trials included conjunctival hemorrhage, eye pain, and vitreous floaters, along with hypertension and nasopharyngitis in the nonocular category of adverse events, according to the company.

CHMP's recommendation to add DME as an indication for aflibercept now goes to the European Commission, the EU's executive body, for ratification.

In the United States, aflibercept is approved for neovascular (wet) age-related macular degeneration and macular edema secondary to central retinal vein occlusion. Regeneron Pharmaceuticals markets the drug here. Regeneron has asked the US Food and Drug Administration to approve the drug for vision impairment caused by DME.

Both Regeneron and Bayer Healthcare also have asked their respective drug regulators to bless yet a fourth indication for aflibercept: treating vision impairment caused by macular edema secondary to branch retinal vein occlusion.


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