Phase III PANORAMA trial of Eylea meets endpoints in non-proliferative diabetic retinopathy.- Regeneron Pharma.
Regeneron Pharma announced that the Phase III PANORAMA trial evaluating Eylea (aflibercept) Injection in patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR) met its one-year (52-week) primary endpoint and key secondary endpoints. On the primary endpoint at one year, 80% and 65% of patients receiving Eylea on an every 8- and every 16-week interval (after an initial monthly dosing period), respectively, experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale, compared to 15% of patients receiving sham injection (p<0.0001).>
Regarding the two key secondary endpoints, which achieved statistical significance based on the pre-specified hierarchical analysis, treatment with Eylea also reduced vision-threatening complications (VTCs) by 82%-85% and the development of center-involved diabetic macular edema (CI-DME) by 68%-74% compared with sham injection. The development of VTCs (proliferative diabetic retinopathy and anterior segment neovascularization) was 3% for the EYLEA every 8-week group, 4% for the Eylea every 16-week group, and 20% for the sham injection group (p<0.001). ci-dme occurred in 8% of the eylea every 8-week group, 7% of the eylea every 16-week group, and 26% of the sham injection group (p><0.001).>
These events collectively occurred in 11% and 10% of patients receiving Eylea every 8 weeks or every 16 weeks, respectively, compared to 41% of patients receiving sham injection (p<0.001).>
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