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FDA Approves Eylea (Aflibercept) for Treatment of Diabetic Macular Edema

Product has indications for macular degeneration and retinal vein occlusion

The FDA has approved Eylea (aflibercept, Regeneron Pharmaceuticals) for the treatment of diabetic macular edema (DME).

The recommended dosage in patients with DME is 2 mg every 8 weeks after five initial monthly injections. Although Eylea may be dosed as often as 2 mg every 4 weeks, additional efficacy was not demonstrated when the product was dosed every 4 weeks compared with every 8 weeks.

The FDA’s approval was based on 1-year data from two phase III trials — VISTA-DME and VIVID-DME — involving a total of 862 patients. These studies compared aflibercept 2 mg every 4 weeks, aflibercept 2 mg every 8 weeks (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed).

The mean changes in best corrected visual acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, for the monthly and bimonthly aflibercept groups were significantly improved compared with the control group and were similar to each other. Across both trials, patients in both aflibercept 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.

In these studies, aflibercept had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups compared with the control group. Arterial thromboembolic events, as defined by the Anti-Platelet Trialists’ Collaboration (i.e., non-fatal stroke, non-fatal myocardial infarction, and vascular death), also occurred at similar rates across treatment groups and the control group. The most common ocular treatment-emergent AEs (TEAEs) observed in the VISTADME and VIVID-DME trials included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most common nonocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequencies in the treatment groups and the control group.

The VISTA-DME and VIVID-DME studies will continue for a total of 3 years.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and to decrease vascular permeability in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in angiogenesis. Aflibercept helps prevent VEGF-A and PlGF from interacting with their natural VEGF receptors, as shown in preclinical studies.

Eylea (aflibercept) is available as a single, 2-mg intravitreal injection for all approved indications. It was approved in the U.S. 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.

Source: Regeneron; July 29, 2014.

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