Industry News — Clinical Updates

FDA Approves Eylea for Treatment of DME

The US Food and Drug Administration (FDA) has approved Eylea (aflibercept; Regeneron Pharmaceuticals, Inc., Tarrytown, NY) for the treatment of diabetic macular edema (DME).The FDA’s recommended dosage is 2 mg every 8 weeks after 5 initial monthly injections. Although aflibercept may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when aflibercept was dosed every 4 weeks compared to every 8 weeks.

The FDA approval of aflibercept for treatment of DME is based on 1-year data from the Phase 3 VISTA-DME and VIVID-DME studies of 862 patients. The data demonstrated that aflibercept 2 mg monthly and aflibercept 2 mg every 2 months after 5 initial monthly doses achieved statistically significant improvements in the primary endpoint of mean change in best-corrected visual acuity (BCVA) at 1 year and the secondary endpoint of proportion of patients who gained at least 15 letters in BCVA vs baseline compared to control.

In VISTA-DME, patients receiving aflibercept 2 mg monthly had a mean change from baseline in BCVA of 12.5 letters (P < .01 compared to control), patients receiving aflibercept 2 mg every 2 months (after 5 initial monthly injections) had a mean change from baseline in BCVA of 10.7 letters (P < .01 compared to control), and patients receiving control treatment had a mean change from baseline in BCVA of 0.2 letters. The percentage of patients who gained at least 15 letters in BCVA from baseline, or 3 lines of vision, was 41.6% in the aflibercept 2 mg monthly group (P < .01 compared to control), 31.1% in the aflibercept 2 mg every 2 months group (after 5 initial monthly injections) (P < .01 compared to control), and 7.8% in the control group.

In VIVID-DME, patients in the aflibercept 2 mg monthly group had a mean change from baseline in BCVA of 10.5 letters (P < .01 compared to control), patients in the aflibercept 2 mg every 2 months group (after 5 initial monthly injections) had a mean change from baseline in BCVA of 10.7 letters (P < .01 compared to control), and patients receiving control had a mean change from baseline in BCVA of 1.2 letters. The percentage of patients who gained at least 15 letters in BCVA from baseline, or 3 lines of vision, was 32.4% in the aflibercept 2 mg every month group (P < .01 compared to control), 33.3% in the aflibercept 2 mg every 2 months group (after 5 initial monthly injections) (P < .01 compared to control), and 9.1% in the control group.

Aflibercept had a similar overall incidence of adverse events (AEs), ocular serious AEs, and nonocular serious AEs across both treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (nonfatal stroke, nonfatal myocardial infarction, and vascular death) also occurred at similar rates across all groups. The most frequent ocular treatment-emergent AEs (TEAEs) observed in both trials included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most common nonocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.

Aflibercept is available as a single, 2 mg injection for all approved indications. It was FDA approved for the treatment of neovascular age-related macular degeneration (AMD) in 2011 and for macular edema following central retinal vein occlusion (CRVO) in 2012

The VISTA-DME and VIVID-DME studies will continue as planned for a total of three years.  

Updated: July 30, 2014

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