Prescribing information

 

The primary efficacy endpoint in both studies was non-inferiority in mean BCVA change from baseline to Week 48 as measured by ETDRS. The primary endpoint was met in both studies.1

 

Anatomical outcomes with Beovu® (brolucizumab) in clinical trials (including post-hoc analysis).

Beovu achieved fluid resolution (absence of SRF, IRF and sub-RPE fluid) in more patients compared with aflibercept at Weeks 16 and 482*

 

Graphs showing the percentage of patients with IRF and/or SRF at Weeks 16, 48 and 96 on Beovu vs aflibercept in the HAWK and HARRIER trials

 

Early superior CST reductions at Week 16 and maintained through Week 481,3*

 

Graphs showing CST reductions from Week 0 to Week 96 for Beovu vs aflibercept in the HAWK and HARRIER trials

 

*Secondary endpoint in HAWK and HARRIER, confirmatory analysis in HAWK only (1-sided p values for superiority of Beovu).1,3
In HAWK and HARRIER post-hoc analysis: HAWK, brolucizumab 6 mg (n=349), aflibercept 2 mg (n=344) (Week 16 p<0.0001, Week 48 p=0.0001); HARRIER, brolucizumab 6 mg (n=348), aflibercept 2 mg (n=346) (Week 16 and 48, p<0.0001)2

BCVA, best corrected visual acuity; CST, central subfield thickness; ETDRS, Early Treatment Diabetic Retinopathy Study; IRF, intraretinal fluid; LS, least squares; RRR, relative risk reduction; SRF, subretinal fibrosis; SRF, subretinal fluid.

References

  1. Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
  2. Singh RP et al. ARVO Annual Meeting 2019.
  3. Novartis data on file. BRODOF20-001 Core Data Sheet.
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UK | October 2021 | 163452
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