Eylea (aflibercept)

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

Approval Status:

Approved September 2012

Specific Treatments:

macular edema following retinal vein occlusion

Therapeutic Areas

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General Information

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

Eylea is specifically indicated for the treatment of macular edema following Retinal Vein Occlusion (RVO), which includes macular edema following Branch Retinal Vein Occlusion (BRVO) in addition to the previously-approved indication of macular edema following Central Retinal Vein Occlusion (CRVO).  

Eylea is supplied as an injection for intravitreal injection. The recommended dose for Eylea is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly).

Clinical Results

FDA Approval

The FDA approval of Eylea for the treatment of macular edema following CRVO was based on two randomized, multi-center, double-masked, sham-controlled studies: COPERNICUS (Controlled Phase 3 Evaluation of Repeated intravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) and GALILEO (General Assessment Limiting Infiltration of Exudates in central retinal vein Occlusion with EYLEA). A total of 358 patients were treated and evaluable for efficacy. In both studies, patients were randomly assigned in a 3:2 ratio to either 2 mg Eylea administered every 4 weeks (Q4), or sham injections (control group) administered every 4 weeks for a total of 6 injections.  After 6 monthly injections, patients continued to receive Eylea treatment during weeks 24 to 52 only if they met pre-specified retreatment criteria (PRN), except for patients in the sham control group in the GALILEO study who continued to receive sham injections through week 52.  Patients ranged in age from 22 to 89 years with a mean of 64 years. In the COPERNICUS study, after six months, 56% of patients receiving Eylea 2 mg monthly gained at least 15 letters of Best Corrected Visual Acuity (BCVA) from baseline, as measured by ETDRS, compared to 12% of patients receiving sham injections (p < 0.01), the primary endpoint of the study. In the GALILEO study, after six months, 60% of patients receiving Eylea 2 mg monthly for the first 6 months, gained at least 15 letters of BCVA from baseline, compared to 22% of patients receiving sham injections (p < 0.01) during this time, the primary endpoint of the study.  

The FDA approval of Eylea for Branch Retinal Vein Occlusion was based on the double-masked, randomized, controlled Phase 3 VIBRANT study of 181 patients with Macular Edema following BRVO. The VIBRANT study compared Eylea 2 mg once every 4 weeks with macular laser photocoagulation (control).  At 24 weeks, significantly more patients treated with Eylea gained at least 15 letters in vision (three lines on an eye chart) from baseline as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, the primary endpoint of the study, compared with patients who received control (53 percent vs. 27 percent).

Side Effects

Adverse effects associated with the use of Eylea 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 macular edema following retinal vein occlusion, please visit https://www.eylea.us/