Phase III trial data for Eylea in Diabetic Macular Oedema - Regeneron Pharma

In the Phase III VIVID-DME trial of Eylea (aflibercept) Injection, from Regeneron Pharmaceuticals, for the treatment of Diabetic Macular Oedema (DMO), Eylea 2 mg monthly (2Q4) and Eylea 2 mg every two months (2Q8) showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared to laser photocoagulation. After two years, patients on Eylea 2Q4 had a mean change from baseline in BCVA of 11.4 letters (10.5 letters at 52 weeks). Patients receiving Eylea 2Q8 had a mean change from baseline in BCVA of 9.4 letters (10.7 letters at 52 weeks). 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 greater than or equal to 15 letters, or approximately 3 lines of vision, from baseline, and 38.2% receiving Eylea 2Q4 achieved an increase of greater than or equal to 15 letters from baseline, compared with 12.1% of patients in the laser control arm achieving similar vision gains. Eylea had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the Eylea treatment groups and the laser control group. Full two-year data from the VIVID-DME trial will be presented at upcoming medical conferences. Both the VIVID-DME and VISTA-DME trials will continue as planned up to 148 weeks.