Achieved similar mean change in BCVA at Week 481
Visual gains achieved with BEOVU were similar to aflibercept1,2
Primary endpoint: Mean change in BCVA vs aflibercept from baseline to Week 481,3,4
The primary endpoint was to demonstrate efficacy in mean change in BCVA from baseline at Week 48, measured by ETDRS letters. Both studies confirmed the hypothesis of noninferiority at Week 48 with a margin of 4.0 letters.1,2
Over half of patients maintained on Q12 at Week 481
Choose BEOVU for Q8-Q12 dosing for your patients immediately after loading1
Dosage & Administration
The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) monthly (approximately every 25-31 days) for the first 3 doses, followed by 1 dose of 6 mg every 8-12 weeks. BEOVU is administered by intravitreal injection.1
Secondary endpoint: % of patients on Q12 with BEOVU at Week 481,2
of patients were
of patients were
All remaining patients were on Q8.2*
BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Study; Q8=treatment every 8 weeks; Q12=treatment every 12 weeks.
*In HAWK, 0 patients treated with BEOVU discontinued the study due to lack of efficacy prior to Week 48. In HARRIER, 1 patient treated with BEOVU discontinued the study due to lack of efficacy prior to Week 48.2
Greater CST reductions2
Greater CST reductions were seen as early as Week 16, and at Week 482
Secondary endpoint: CST reductions vs aflibercept from baseline to Week 483-5
In HAWK, superior CST reductions were achieved at Week 16 and Week 48. In HARRIER, P values are nominal and not adjusted for multiplicity.2 Clinical significance has not been established. No conclusions of efficacy may be drawn.
Results seen with
over half of patients on Q12 at Week 48
(56% and 51%)1
CST=central subfield thickness.
An actual patient's CST response6
Actual patient OCT scans taken by HAWK investigators are representative of the
average CST response from baseline to Week 48. Individual results may vary.
OCT=optical coherence tomography.
Fewer patients with IRF and/or SRF2
Fewer patients with IRF and/or SRF as early as Week 16, and at Week 482
Secondary endpoint: % of patients with IRF and/or SRF vs aflibercept at Weeks 16 and 483,4
In HAWK, superior reductions in the percentage of patients with IRF and/or SRF were achieved at Week 16 and Week 48. In HARRIER P values are nominal and not adjusted for multiplicity.2 Clinical significance has not been established. No conclusions of efficacy may be drawn.
At Week 48,
over half of patients
in the study
were maintained on Q12
(56% and 51%)1
IRF=intraretinal fluid; SRF=subretinal fluid.
References: 1. Beovu [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
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; December 2018.
4. Data on file. RTH258-C002 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2018. 5. Data on file. RTH258-C001 & RTH258-C002 CST. Novartis Pharmaceuticals Corp; September 2019. 6. Data on file. RTH258-C001 OCT image. Novartis Pharmaceuticals Corp; September 2019.