SEE THE
STUDY DESIGN

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

STUDY DESIGN

WET AMD DATA

Clinical Profile

WEEK 48 WEEK 96

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

Hawk Created with Sketch.
Harrier Created with Sketch.

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

Graph of the mean change in BCVA vs aflibercept from baseline to Week 96 Graph of the mean change in BCVA vs aflibercept from baseline to Week 96

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

WEEK 48 WEEK 96

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.

WEEK 48 WEEK 96

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

Hawk Created with Sketch.
Harrier Created with Sketch.

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

CST Reductions Mean Change From Baseline to Week 96 CST Reductions Mean Change From Baseline to Week 96

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.

Image of baseline CST Image of baseline CST

BASELINE

CST: 498 µm

Image of patient oct scans at week 16 and 48 Image of patient oct scans at week 16 and 48

WEEK 16

CST: 300 µm

IRF/SRF Patients at Weeks 48 IRF/SRF Patients at Weeks 48

WEEK 48

CST: 313 µm

BEOVU Patient OCT Scans week 96 BEOVU Patient OCT Scans week 96

WEEK 96

CST: 286 µm

OCT=optical coherence tomography.

OCT=optical coherence tomography.

WEEK 48 WEEK 96

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

Hawk Created with Sketch.
Harrier Created with Sketch.

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

IRF/SRF Patients at Weeks 16, 48 and 96 IRF/SRF Patients at Weeks 16, 48 and 96

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.

❮ BACK TO TOP
❮ WET AMD DOSING &
 ADMINISTRATION
❮ BACK TO TOP
WET AMD SAFETY
PROFILE ❯

INDICATIONS AND USAGE

IMPORTANT SAFETY INFORMATION

COLLAPSE

EXPAND

IMPORTANT SAFETY INFORMATION

BEOVU® (brolucizumab-dbll) injection is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME).

CONTRAINDICATIONS

BEOVU is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to brolucizumab or any of the excipients in BEOVU. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

Endophthalmitis and Retinal Detachment

Intravitreal injections, including those with BEOVU, have been associated with endophthalmitis and retinal detachment. Proper aseptic injection techniques must always be used when administering BEOVU. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

Retinal Vasculitis and/or Retinal Vascular Occlusion

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU. These immune-mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events. Patients treated with BEOVU who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored. Patients should be instructed to report any change in vision without delay.

Increase in Intraocular Pressure

Acute increases in intraocular pressure (IOP) have been seen within 30 minutes of intravitreal injection, including with BEOVU. Sustained IOP increases have also been reported. Both IOP and perfusion of the optic nerve head must be monitored and managed appropriately.

Thromboembolic Events

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the BEOVU clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The ATE rate in the two controlled 96-week neovascular AMD (nAMD) studies (HAWK and HARRIER) during the first 96-weeks was 4.5% (33 of 730) in the pooled brolucizumab arms compared with 4.7% (34 of 729) in the pooled aflibercept arms.

ADVERSE REACTIONS

Serious adverse reactions, including endophthalmitis, retinal detachment, retinal vasculitis and/or retinal vascular occlusion, increases in intraocular pressure, and arterial thromboembolic events, have occurred following intravitreal injections with BEOVU.

The most common adverse events (≥5% of patients) reported in nAMD clinical studies (HAWK and HARRIER) in patients who received BEOVU were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters, and eye pain. The most common adverse event (≥5% of patients) reported in DME clinical studies (KITE and KESTREL) in patients who received BEOVU was conjunctival hemorrhage.

In a clinical study (MERLIN), patients with nAMD who received BEOVU every 4-week maintenance dosing experienced a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion than patients who received BEOVU every 8- or 12-week maintenance dosing in the clinical studies (HAWK and HARRIER). The interval between 2 BEOVU doses during maintenance treatment should not be less than 8 weeks.

As with all therapeutic proteins, there is a potential for an immune response in patients treated with BEOVU. Anti-brolucizumab antibodies were detected in the pre-treatment sample of 36% to 64% of treatment-naive patients. After initiation of dosing, anti-brolucizumab antibodies were detected in at least one serum sample in 53% to 76% of patients treated with BEOVU. Intraocular inflammation was observed in 6% of patients with anti-brolucizumab antibodies detected during dosing with BEOVU in clinical trials. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, are immune-mediated adverse events related to exposure to BEOVU. This treatment-emergent antibody response may develop following the first intravitreal injection. Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy.

INDICATIONS AND USAGE

BEOVU® (brolucizumab-dbll) injection is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME).

Please see full Prescribing Information for BEOVU.