Table 20: Percent 3-line gainers at Week 24, 52, 76/100, COPERNICUS, GALILEO, (full analysis set with LOCF). S=Sham and Af= Aflibercept COPERNICUS GALILEO 24 weeks 52 100 24 52 100 weeks weeks n S Af S Af S Af S Af S Af S Af 73 114 73 114 103 103 68 103 Gained 15 56 30 letters (%) wt’d difference 45% 26% 27% 38% 28% 28% (95% CI) (33%, (12%, (13%, (24%, (13%, (13%, 57%) 40%) 40%) 52%) 43%) 43%) p-value p<0.001 p<0.001 p<0.001 p<0.001 p<0.001 p<0.001 Table 21: Comparison of efficacy outcomes at 12 and 24 weeks GALILEO COPERNICUS POOLED Sham Sham Aflib. Sham n=68 n=103 n=73 n=114 n=141 n=217 Gained 15 Week 12 8 60 7 64 15 126 letters (1) (12%) (58%) (10%) (56%) (11%) (58%) Week 24 15 62 9 66 24 131 (22%) (60%) (12%) (58%) (17%) (60%) mean Week 12 1.7 16.5 -4.2 16.7 -1.4 16.6 change in BVCA (2) Week 24 3.3 18.0 -4.0 17.3 -0.5 17.7 mean Week 12 -75.1 -441.4 -88.5 -441.8 change in central retinal Week 24 -114.8 -457.2 -157.2 -453.1 thickness (2) Primary endpoint Secondary endpoints Comment: Most gains observed at 24 weeks were already gained by 12 weeks. Safety Aflibercept is already registered for neovascular (wet) age-related macular degeneration. No new safety concerns have emerged from the development program for the indication being considered in this application (macular oedema secondary to CRVO).
Table 20: Percent 3-line gainers at Week 24, 52, 76/100, COPERNICUS, GALILEO, (full analysis set with LOCF). S=Sham and Af= Aflibercept COPERNICUS GALILEO 24 weeks 52 100 24 weeks 52 100 weeks n S Af S 73 Af 114 S 73 Af 114 S Af 103 S Af 103 S 68 Af 103 Gained 15 letters (%) 56 30 wt’d difference (95% CI) p-value 45% (33%, 57%) p<0.001 26% (12%, 40%) p<0.001 27% (13%, 40%) p<0.001 38% (24%, 52%) p<0.001 28% (13%, 43%) p<0.001 28% (13%, 43%) p<0.001 Table 21: Comparison of efficacy outcomes at 12 and 24 weeks GALILEO COPERNICUS POOLED Sham n=68 n=103 Sham n=73 Aflib. n=114 Sham n=141 n=217 Gained 15 letters (1) Week 12 8 (12%) 60 (58%) 7 (10%) 64 (56%) 15 (11%) 126 (58%) Week 24 15 (22%) 62 (60%) 9 (12%) 66 (58%) 24 (17%) 131 (60%) mean change in BVCA (2) Week 12 1.7 16.5 -4.2 16.7 -1.4 16.6 Week 24 3.3 18.0 -4.0 17.3 -0.5 17.7 mean change in central retinal thickness (2) Week 12 -75.1 -441.4 -88.5 -441.8 Week 24 -114.8 -457.2 -157.2 -453.1 Primary endpoint Secondary endpoints Comment: Most gains observed at 24 weeks were already gained by 12 weeks. Safety Aflibercept is already registered for neovascular (wet) age-related macular degeneration. No new safety concerns have emerged from the development program for the indication being considered in this application (macular oedema secondary to CRVO).
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