Prescribing information

 

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Treatment interval outcomes with Beovu® (brolucizumab) in clinical trials.

Maintained a majority of patients on a q12w interval with Beovu at Week 481*

  • The only anti-VEGF recommended to start eligible patients on q12w intervals immediately after loading1–6†
  • In HAWK and HARRIER, after loading with 3 monthly injections, Beovu was injected q12w unless disease activity was identified, resulting in permanent adjustment to q8w. Adequacy of the Beovu q12w interval was assessed at Week 16 and at scheduled q12w treatment visits (disease activity assessments at Weeks 20, 32 and 44)1
  • After the loading phase, of the patients who had a successful* q12w interval start with Beovu, 85% (HAWK) and 82% (HARRIER) remained on q12w interval through Week 481

Graphs showing the percentage of patients on the q8w and q12w intervals at Week 48 with Beovu in the HAWK and HARRIER trials

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

*All remaining patients were maintained on q8w.1
Based on disease activity as assessed by visual acuity and/or anatomical parameters. A disease activity assessment is suggested 16 weeks (4 months) after treatment start. In patients without disease activity, treatment every 12 weeks (3 months) should be considered.
In HAWK and HARRIER, after loading with 3 monthly injections, Beovu was injected q12w unless disease activity was identified, resulting in permanent adjustment to q8w. Adequacy of the Beovu q12w interval was assessed at Week 16 and at scheduled q12w treatment visits (disease activity assessments at Weeks 20, 32 and 44).1

BCVA, best corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; q8w, once every 8 weeks; q12w, once every 12 weeks; VEGF, vascular endothelial growth factor.

References

  1. Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
  2. Novartis data on file. BRODOF20-001 Core Data Sheet; 2019.
  3. Novartis Pharmaceuticals UK Ltd. Lucentis (ranibizumab) Summary of Product Characteristics, United Kingdom, September 2020.
  4. Bayer Eylea (aflibercept) Summary of Product Characteristics, United Kingdom, August 2021.
  5. Novartis Pharmaceuticals UK Ltd. Beovu® (brolucizumab) Summary of Product Characteristics, Great Britain, December 2021.
  6. Novartis Pharmaceuticals UK Ltd. Beovu® (brolucizumab) Summary of Product Characteristics, Northern Ireland, November 2021.
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UK | December 2021 | 151717-2
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