Date: 2014-10-17
Type of information: Results
phase: 3
Announcement: results
Company: Bayer Healthcare (Germany) Regeneron Pharmaceuticals (USA - CA)
Product: Eylea® (aflibercept)
Action
mechanism: fusion protein/VEGF receptor. Eylea® is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Eylea® acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.
Disease: diabetic macular edema
Therapeutic area: Ophtalmological diseases
Country: USA
Trial
details: The independent, government-sponsored study was designed to determine if one of three different anti-VEGF therapies is superior to the others for the treatment of diabetic macular edema (DME). In the study, 660 patients were randomized to receive either Eylea® 2 milligrams (mg), bevacizumab 1.25 mg, or ranibizumab 0.3 mg dosed according to a protocol-specified algorithm. Patients were treated with focal/grid laser at or after the 24 week visit if: 1) the OCT central subfield thickness was greater than or equal to 250 microns or there was edema that was threatening the fovea and 2) the eye did not improve on OCT or visual acuity from the last two consecutive injections. (NCT01627249)
Latest
news: * On October 17, 2014, Regeneron Pharmaceuticals announced that in the National Institutes of Health (NIH) sponsored, Diabetic Retinopathy Clinical Research Network (DRCR.net) comparative effectiveness study in patients with Diabetic Macular Edema (Protocol T), Eylea® (aflibercept) Injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity (BCVA) from baseline at 52 weeks compared to both bevacizumab (Avastin® /Genentech) and ranibizumab injection (Lucentis®/Genentech), the primary endpoint of the study. The median number of injections using the protocol-specified retreatment regimen was one fewer in patients treated with EYLEA compared to bevacizumab and ranibizumab. Fewer patients in the Eylea® group received criteria-based macular laser treatments than those treated with bevacizumab and ranibizumab. The rates of most ocular and systemic adverse events (AEs) were similar across the three study groups. The rates of arterial thromboembolic events as defined by the Anti-Platelet Trialists\' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) in the trial were 2 percent in the Eylea® group, 4 percent in the bevacizumab group and 5 percent in the ranibizumab group. There were more overall cardiovascular events in the ranibizumab group, compared to the Eylea® group and the bevacizumab group (nominal p less than 0.01); this included more cardiac events and cerebrovascular events in the ranibizumab group.DRCR.net has shared these top-line results with study investigators. DRCR.net is in the process of finalizing and verifiying the data prior to submission for publication. Regeneron understands that DRCR.net intends to present the final results at a future medical conference simultaneous to, or soon after, publication, and that the DRCR.net will not be publicly discussing the results prior to publication.
