gy (central retinal thickness [CRT] as assessed by OCT). Improvements in mean CRT were maintained through week 24.
Retinal thickness on OCT at week 24 compared to baseline was a secondary efficacy variable in both COPERNICUS and GALILEO study. In both studies, the mean change in retinal thickness from baseline to week 24 was statistically significant favouring Eylea.
Table 2: Pharmacodynamic parameter at week 24, week 52 and week 76/100 (Full Analysis Set with LOCF) in COPERNICUS and GALILEO studies
Efficacy Outcomes
COPERNICUS
GALILEO
24 Weeks
52 Weeks
100 Weeks
24 Weeks
52 Weeks
76 Weeks
Control
Eylea
2 mg Q4
ControlC)
Eylea
2 mg
Control C,D)
EyleaD)
2 mg
Control
Eylea
2 mg Q4
Control
Eylea
2 mg
ControlE)
Eylea E)
2 mg
(n = 73)
(n = 114)
(n = 73)
(n = 114)
(n = 65)
(n = 112)
(n = 67)
(n = 103)
(n = 67)
(n = 103)
(n = 67)
(n = 103)
Mean change in retinal thickness from baseline
-145
-457
-382
-413
-343
-390
-169
-449
-219
-424
-306
-389
Difference in LS meanA,B,C)
(95% CI)
-312
(-389, -234)
-28
(-121, 64)
-45
(-142, 53)
-239
(-286, -193)
-167
(-217, -118)
-44
(-99, 10)
p-value
p < 0.0001
p = 0.5460
p=0.3661
p < 0.0001
p < 0.0001
p=0.1122
A) Difference is Eylea 2 mg Q4 minus control
B) LS: Least square mean difference and confidence interval (CI) based on an ANCOVA model with baseline value as covariate and factors treatment group, region (America vs. rest of the world for COPERNICUS and Europe vs. Asia/Pacific for GALILEO) and baseline BCVA category (> 20/200 and ≤ 20/200)
C) In COPERNICUS study, control group patients could receive Eylea on an as-needed basis as frequently as every 4 weeks during week 24 to week 52
D) In COPERNICUS study, both control group and Eylea 2mg patients received Eylea 2 mg on an as-needed basis as frequently as every 4 weeks starting from Week 52 to Week 88
E) In GALILEO study, both control group and Eylea 2mg patients received Eylea 2 mg on an as-needed basis every 8 weeks starting from Week 52 to Week 68.
Clinical efficacy and safety
wet AMD
The safety and efficacy of Eylea were assessed in two randomised, multi-centre, double-masked, active-controlled studies in patients with wet AMD. A total of 2,412 patients were treated and eva luable for efficacy (1,817 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:
1) Eylea administered at 2 mg every 8 weeks following 3 initial monthly doses (Eylea 2Q8);
2) Eylea administered at 2 mg every 4 weeks (Eylea 2Q4);
3) Eylea administered at 0.5 mg every 4 weeks (Eylea 0.5Q4); and
4) ranibizumab administered at 0.5 mg every 4 weeks (ranibizumab 0.5Q4).
Patient ages ranged from 49 to 99 years with a mean of 76 years.
In the second year of the studies, patients continued to receive the dosage strength to which they were initially ra |
