Eylea - Aflibercept
The safety and efficacy of EYLEA were assessed in two randomized, multi-center, double-masked, active-controlled studies in patients with wet AMD.
A total of 2412 patients were treated and evaluable for efficacy (1817 with EYLEA) in the two studies (VIEW1 and VIEW2). In each study, patients were randomly assigned in a 1:1:1:1 ratio to 1 of 4 dosing regimens:
- EYLEA administered 2 mg every 8 weeks following 3 initial monthly doses (EYLEA 2Q8);
- EYLEA administered 2 mg every 4 weeks (EYLEA 2Q4);
- EYLEA 0.5 mg administered every 4 weeks (EYLEA 0.5Q4);
- ranibizumab administered 0.5 mg every 4 weeks (ranibizumab 0.5 mg Q4)
Patient ages ranged from 49 to 99 years with a mean of 76 years. In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing fewer than 15 letters of visual acuity at week 52 compared to baseline. Data are available through week 52. Both EYLEA 2Q8 and EYLEA 2Q4 groups were shown to have efficacy that was clinically equivalent to the ranibizumab 0.5 mg Q4 group.
