Regeneron announced results from its Phase 3 VIVID-DME trial of Eylea (aflibercept) injection for the treatment of diabetic macular edema (DME). Eylea 2mg dosed monthly (2Q4) and Eylea 2mg dosed every two months (after 5 initial monthly injections, 2Q8) showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100 (2 years), compared to laser photocoagulation.
Patients in VIVID-DME were randomized to receive either Eylea 2Q4 (n=136), Eylea 2Q8 (n=135), or the comparator treatment of laser photocoagulation (n=132). Patients were eligible to receive rescue treatment from week 24 onwards. Rescue treatment in the Eylea groups was adjunct laser treatment, and in the laser control group it was Eylea 2mg. The primary endpoint is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart.
After two years, patients receiving Eylea 2Q4 had a mean change from baseline in BCVA of 11.4 letters (10.5 letters at 52 weeks (P<0.0001 vs. laser). Patients receiving Eylea 2Q8 had a mean change from baseline in BCVA of 9.4 letters (10.7 letters at 52 weeks (P<0.0001 vs. laser). Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.7 letters (1.2 letters at 52 weeks). Additionally, 31.1% of patients receiving Eylea 2Q8 achieved an increase of ≥15 letters, or approximately 3 lines of vision, from baseline (P=0.0001), and 38.2% receiving Eylea 2Q4 achieved an increase of ≥15 letters from baseline (P<0.0001 vs. laser), compared with 12.1% of patients in the laser control arm achieving similar vision gains.
Eylea is already approved for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (CRVO).
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