FDA approves Eylea for treatment of DME

Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) announced July 29 that the FDA has approved Eylea (aflibercept) Injection for the treatment of DME. The recommended dosage in patients with DME is 2 mg every eight weeks after five initial monthly injections.

Although Eylea may be dosed as frequently as 2 mg every four weeks, the clinical studies did not demonstrate additional efficacy compared to every-eight-week dosing, according to a press release from Regeneron.

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 and every two months (after five initial monthly injections) and macular laser photocoagulation (at baseline and then as needed), according to the press release.

In the DME studies, after one year, the mean changes in 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, according to the press release. Across both trials, patients in both Eylea dosing groups gained an average of 2 lines of vision vs. almost no change in the control group, the Regeneron press release stated.

In these trials, Eylea had a similar overall incidence of adverse events (AEs), ocular serious AEs and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction and vascular death) also occurred at similar rates across treatment groups and the control group.

The most frequent ocular treatment emergent AEs (TEAEs) observed in the VISTA-DME and VIVID-DME trials included conjunctival hemorrhage, eye pain, cataract and vitreous floaters. The most common non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and 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 treatment of wet AMD in 2011 and for treatment of macular edema following CRVO in 2012.

EYLEA has also been approved in the EU and other countries for use in wet AMD and macular edema following CRVO. In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for Eylea in the treatment of DME. Regeneron has also filed regulatory submissions in Japan, Asia Pacific and Latin America for the treatment of DME, according to the press release.

Regeneron has submitted an application with the FDA and EU for Eylea for the treatment of macular edema following BRVO.

Link here for the full press. Full prescribing information is available on the Regeneron website.