WET AMD DATA
Study design and baseline characteristics
Head-to-head trials designed to determine patients eligible for Q121,2
HAWK & HARRIER: 2-head-to-head clinical trials for BEOVU vs aflibercept1,2
2-head-to-head clinical trials for
BEOVU vs aflibercept1,2
Maintenance phase continued through study end (Week 96).3,4
*DAAs occurred at Weeks 16, 20, 32, 44, 56, 68, 80, and 92 with additional assessments in HARRIER at Weeks 28, 40, 52, 64, 76, and 88.3,4WEEK 16
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). 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 naive2
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]); ETDRS=Early Treatment Diabetic Retinopathy Study; IRF=intraretinal fluid; Q8=treatment every 8 weeks; Q12=treatment every 12 weeks; SRF=subretinal fluid; sub-RPE=subretinal pigment epithelium.
References: 1. Beovu [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; May 2022.
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. 2020;127(1):72-84.
3. Data on file. RTH258-C001 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2018. 4. Data on file. RTH258-C002 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2018.