General Information

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

Eylea is specifically indicated for the treatment of diabetic retinopathy of all stages, including in patients with diabetic macular edema (DME).

Eylea is supplied as an intravitreal injection. The recommended dosage of Eylea in patients with diabetic retinopathy 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.

The FDA approval of Eylea for diabetic retinopathy was based on six-month and one-year results from PANORAMA, a randomized, multi-center, controlled Phase 3 trial that enrolled 402 patients and was designed to investigate Eylea for the improvement of moderately severe to severe NPDR without diabetic macular edema (DME), compared to sham injection. There were three treatment arms – an observational sham injection group and two Eylea treatment groups. Eylea was dosed every eight weeks (following five initial monthly doses) or every 16 weeks (following three initial monthly doses and one eight-week interval). The primary endpoint was the proportion of patients who experienced a two-step or greater improvement in the diabetic retinopathy severity scale (DRSS) from baseline for the combined Eylea treatment groups at week 24, and for each Eylea treatment group separately (every eight-week group and every 16-week group) at week 52. The DRSS is a systematic grading scale to assess DR severity based on photographs of the retina.

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.