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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 March 2015

Specific Treatments:

diabetic retinopathy in patients with 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 retinopathy in patients with diabetic macular edema (DME).

Eylea is supplied as an intravitreal injection. The recommended dosage of Eylea in patients with diabetic retinopathy in DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections.  Although Eylea may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when Eylea was dosed every 4 weeks compared to every 8 weeks.

Clinical Results

FDA Approval

The FDA approval of Eylea for the treatment of diabetic retinopathy in DME was based on two year data from the Phase III VISTA-DME and VIVID-DME studies of 862 patients, which compared Eylea 2 mg monthly, Eylea 2 mg every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed).  In these studies, on the primary endpoint of mean change in Best Corrected Visual Acuity (BCVA) at one year, patients treated with Eylea monthly or every two months showed statistically significant improvements compared to the control group. Patients in both Eylea 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 diabetic retinopathy in patients with diabetic macular edema 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 retinopathy in patients with diabetic macular edema, please visit https://www.eylea.us/

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