
WET AMD DATA
Clinical Profile


Achieved similar mean change in BCVA at Week 481
Visual acuity 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
Visual acuity gains at Week 48 were maintained at Week 961
Mean change in BCVA vs aflibercept from baseline to Week 961,3,4


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
Week 96 data for HAWK and HARRIER were descriptive only. *Week 96 P values were not statistically significant.
BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Study; Q12=treatment every 12 weeks.
BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Study; Q12=treatment every 12 weeks.
Over half of patients maintained on Q12 at Week 481
Choose BEOVU for Q8-Q12 dosing for your patients immediately after loading.1
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
HAWK
0%
of
patients were
on
Q12
HARRIER
0%
of
patients were
on
Q12
All remaining patients were on Q8.2†
†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
Secondary endpoint: % of patients on Q12 with BEOVU at Week 961,3,4
HAWK
45%
of
patients were
on
Q12
HARRIER
39%
of
patients were
on
Q12
All remaining patients were on Q8.5
Q8=treatment every 8 weeks.
Q8=treatment every 8 weeks.


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 483,4,6
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.
Greater reduction in CST was not seen with BEOVU 6 mg vs aflibercept at Week 20, which was the end of the initial Q12 cycle in the HAWK trial.3
Greater reductions in CST through Week 965,6
Greater CST reductions were seen as early as Week 16 and at Weeks 48 and 962,5,6
Secondary endpoint: CST reductions vs aflibercept from baseline to Week 963-6


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 Week 96 data for HAWK and HARRIER were descriptive only. Clinical significance has not been established. No conclusions of efficacy may be drawn.
Greater reduction in CST was not seen with BEOVU 6 mg vs aflibercept at Week 20, which was the end of the initial Q12 cycle in the HAWK trial.3
CST=central subfield thickness.
CST=central subfield thickness.
Results seen with
over
half of patients on Q12 at
Week 48
(56%
and 51%)1
An actual patient’s CST response7
Actual patient OCT scans taken by HAWK investigators are
representative
of the average
CST response. Individual results may vary.
OCT=optical coherence tomography.
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.
Fewer patients with IRF and/or SRF through Week 965
Fewer patients with IRF and/or SRF as early as Week 16 and at Weeks 48 and 962,5
Secondary endpoint: % of patients with IRF and/or SRF vs aflibercept at Weeks 16, 48, and 963-5,8


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 Week 96 data for HAWK and HARRIER were descriptive only. Clinical significance has not been established. No conclusions of efficacy may be drawn.
IRF=intraretinal fluid; SRF=subretinal fluid.
At Week 48,
over
half of patients
in
the study
were maintained on Q12
(56%
and 51%)1
References: 1. Beovu [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 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. 5. Dugel PU, Singh RP, Koh A, et al. HAWK and HARRIER: Ninety-six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020. doi:10.1016/j.ophtha.2020.06.028. 6. Data on file. RTH258-C001 & RTH258-C002 CST. Novartis Pharmaceuticals Corp; September 2019. 7. Data on file. RTH258-C001 OCT image. Novartis Pharmaceuticals Corp; September 2019. 8. Data on file. RTH258-C001 & RTH258-C002 IRF and/or SRF. Novartis Pharmaceuticals Corp; October 2019.