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Eylea (aflibercept)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved July 2014

Specific Treatments:

diabetic macular edema

Therapeutic Areas

General Information

Eylea (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor.

Eylea is specifically indicated for the treatment of diabetic macular edema.

Eylea is supplied as an injection for intravitreal injection. The recommended dose of Eylea for DME is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although Eylea may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when Eylea was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months). 

Clinical Results

FDA Approval

The FDA approval of Eylea in DME was based on the one-year data from the Phase 3 VISTA-DME and VIVID-DME studies of 862 patients, which compared Eylea 2 mg given monthly, Eylea 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In the DME studies, after one year, the mean changes in Best Corrected Visual Acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for the monthly and every two month Eylea groups, were statistically significantly improved compared to the control group and were similar to each other. Across both trials, patients in both Eylea dosing groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group.

Side Effects

Adverse effects associated with the use of Eylea for DME may include, but are not limited to, the following:

conjunctival hemorrhage

eye pain

cataract

vitreous detachment

vitreous floaters

intraocular pressure increased

Mechanism of Action

Eylea (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor. Eylea is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through  blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis.

Additional Information

For additional information regarding Eylea or diabetic macular edema please visit https://www.eylea.us/

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