Eylea shows benefits in DMO trial-Regeneron/Bayer HealthCare
In the Phase III VISTA-DME trial of Eylea (aflibercept) Injection, from Regeneron and Bayer HealthCare, for the treatment of Diabetic Macular Oedema (DMO), Eylea 2 mg dosed monthly (2Q4) and 2 mg dosed 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 receiving Eylea 2Q4 had a mean change from baseline in BCVA of 11.5 letters (12.5 letters at 52 weeks). Patients receiving Eylea 2Q8 had a mean change from baseline in BCVA of 11.1 letters (10.7 letters at 52 weeks).
Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.9 letters (0.2 letters at 52 weeks). Eylea was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the treatment groups and the laser control group.
Full two-year data from the VISTA-DME trial will be presented at upcoming medical conferences. Two-year data from the similarly designed VIVID-DME trial are expected later in 2014.