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Bayer’s Eylea gets FDA approval for diabetic macular edema treatment

Bayer has received approval from the US Food and Drug Administration (FDA) for aflibercept solution for injection into the eye (EYLEA) to treat diabetic macular edema (DME) in the US.

In many countries, aflibercept solution for injection has already been approved as EYLEA to treat patients with neovascular age-related macular degeneration (wet AMD) and visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).

The company said that DME is the third approved indication for Eylea in the US and the approval is based on positive data from the Phase III VISTA-DME and VIVID-DME clinical trials, which included 862 patients.

The trials compared aflibercept solution for injection 2mg given monthly, 2mg given every two months after five initial monthly injections, or macular laser photocoagulation at baseline and then as needed.

After one-year, the mean changes in best-corrected visual acuity (BCVA) were significantly improved compared to the control group and were similar to each other in the clinical trials.

BCVA is measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart for the monthly and every two month treatment arms.

Eylea includes portions of human vascular endothelial growth factor (VEGF) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration.

Bayer and Regeneron are collaborating on the global development of Eylea, with Regeneron maintaining exclusive rights of the drug in the US and Bayer having exclusive marketing rights outside the US.