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EYLEA® (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema

Aug 1, 2014
 

Diabetic macular edema (DME) is a leading cause of vision loss among working-age adults…. 

The 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.

 

EYLEA is available as a single, 2-mg strength intravitreal injection for all approved indications. EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in 2011, and for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012.

In the Phase 3 VISTA-DME and VIVID-DME trials, EYLEA® (aflibercept) Injection 2 mg dosed monthly and EYLEA 2 mg dosed every two months after 5 initial monthly doses achieved statistically significant improvements in the primary endpoint of mean change in BCVA at one year and the secondary endpoint of proportion of patients who gained at least 15 letters in BCVA versus baseline compared to control.

Diabetic Macular Edema (DME) or "swelling of the macula" is a common complication in the eyes of patients with diabetes. It is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness. It is estimated that of the 29.1 million American adults living with diabetes, 1.5 million have been diagnosed with DME, and approximately another million cases are undiagnosed.

DME occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes. This allows fluid from blood vessels to leak into the retina, causing macular swelling. Fluid in the macula can cause severe vision loss or blindness. The macula is the part of the retina responsible for central, fine vision.

Vascular endothelial growth factor (VEGF), a naturally occurring family of growth factors in the body, appears to play a critical role in the development of DME. Increased VEGF production contributes to the vascular disruptions and leakage that characterize DME, as well as the formation of new blood vessels (a process known as angiogenesis).

EYLEA is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. 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. EYLEA helps prevent VEGF-A and PlGF from interacting with their natural VEGF receptors as shown in preclinical studies.

Practice Pearls:
  • EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with: Wet AMD
  • 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.
  • The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye and vitreous (gel-like substance) detachment.

Regeneron Press Release