ly doses. From Baseline to Week 52, ranibizumab 0.5 mg was dosed every 4 weeks. Beginning at Week 52, all groups were treated using a modified quarterly treatment paradigm where patients could be dosed as frequently as every 4 weeks but not less frequently than every 12 weeks based upon pre-specified retreatment criteria.
The proportion of patients at week 96 gaining at least 15 letters from baseline was 33.44% in the Eylea 2Q8 group, and 31.60% in the ranibizumab 0.5Q4 group.
In combined data analysis of the VIEW1 and VIEW2 studies Eylea demonstrated clinically meaningful changes from baseline in pre-specified secondary efficacy endpoint National Eye Institute Visual Function Questionnaire (NEI VFQ-25). The magnitude of these changes was similar to that seen in published studies, which corresponded to a 15-letter gain in Best Corrected Visual Acuity (BCVA).
No clinically meaningful differences were found between Eylea and the reference product ranibizumab in changes of NEI VFQ-25 total score and subscales (near activities, distance activities, and vision-specific dependency) at week 52 from baseline.
Decreases in mean CNV area were evident in all dose groups in both studies.
Efficacy results in all eva luable subgroups (e.g. age, gender, race, baseline visual acuity, lesion type, lesion size) in each study and in the combined analysis were consistent with the results in the overall populations.
In the second year of the studies, efficacy was generally maintained through the last assessment at week 96.
In the second year of the studies, 2-4% of patients required all injections on a monthly basis, and a third of patients required at least one injection with a treatment interval of only one month.
Eldrly Population
In the clinical studies, approximately 89% (1,616/1,817) of the patients randomised to treatment with Eylea were 65 years of age or older and approximately 63% (1,139/1,817) were 75 years of age or older.
Macular Oedema secondary to CRVO
The safety and efficacy of Eylea were assessed in two randomised, multi-centre, double-masked, sham-controlled studies in patients with macular oedema secondary to CRVO. A total of 358 patients were treated and eva luable for efficacy (217 with Eylea) in the two studies COPERNICUS and GALILEO. In both studies, patients were randomly assigned in a 3:2 ratio to either 2 mg Eylea administered every 4 weeks (2Q4) or the control group receiving sham injections every 4 weeks for a total of 6 injections.
After 6 monthly injections, patients received treatment only if they met pre-specified retreatment criteria, except for patients in the control group in the GALILEO study who continued to receive sham (control to control) until week 52. Starting from this timepoint all patients were offered treatment if they met pre-specified criteria.
Patient ages ranged from 22 to 89 years with a mean of 64 years.
In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in BCVA at week 24 compared to baseline.
Change in visual acuity at week 24 compared to baseline was a secondary efficacy variable in both COPERNICUS and GALILEO studies.
The difference between treatment groups was statistically significant in favour of Eylea in both studies. In both pivotal studies the maximal improvement in visual acuity has been achieved at month 3 with subsequent stabilisation of the effect on visual acuity and central retinal thickness until month 6. The statistically significant diff |
