Study design and baseline characteristics
Head-to-head trials designed to determine patients eligible for Q121,2
The safety and efficacy of BEOVU were assessed in 2 randomized, multicenter, double-masked, active-controlled, 2-year, Phase III studies in patients with wet AMD (N=1459). The primary endpoint demonstrated noninferiority in mean change in BCVA from baseline to Week 48 vs aflibercept as measured by ETDRS letters. Patients were randomized to either BEOVU 6 mg or aflibercept 2 mg (Q8 per label). Disease Activity Assessments (DAAs) were conducted throughout the trial at prespecified intervals. After 3 initial monthly doses, treating physicians decided whether to treat each patient on a Q8 or Q12 interval guided by visual and anatomical measures of disease activity, although the utility of these measures has not been established. Patients with disease activity at Week 16 or at any DAA could be adjusted to Q8 for the remainder of the study.1,2
BEOVU was studied in 730 patients worldwide1,2
Baseline ocular characteristics were well balanced across treatment arms3,4
All patients were treatment na´ve2
AMD=age-related macular degeneration; BCVA=best corrected visual acuity; CNV=choroidal neovascularization; CST=central subfield thickness; DAA=disease activity assessment (comprised of functional [BCVA] and anatomical parameters [IRF and/or SRF, CST, sub-RPE]); sub-RPE=sub-retinal pigment epithelium; ETDRS=Early Treatment Diabetic Retinopathy Study; IRF=intraretinal fluid; SRF=sub-retinal fluid; Q8=treatment every 8 weeks; Q12=treatment every 12 weeks.
*Maintenance phase continued through study end (Week 96).3,4
†DAAs occurred at Weeks 16, 20, 32, and 44 with additional assessments in HARRIER at Weeks 28 and 40.3,4
References: 1. Beovu [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; October 2019. 2. Dugel PU, Koh A, Ogura Y, et al, on behalf of the HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2019. doi:10.1016/j.ophtha.2019.04.017. 3. Data on file. RTH258-C001 Clinical Study Report. Novartis Pharmaceuticals Corp; 2018. 4. Data on file. RTH258-C002 Clinical Study Report. Novartis Pharmaceuticals Corp; 2018.