Prescribing information

Two randomised, multicentre, double-masked, active-controlled Phase lll studies.

HAWK and HARRIER: prospective head-to-head trials with q12w intervals immediately after loading in eligible patients1*

Diagram showing the treatment schedule for Beovu and aflibercept in the HAWK and HARRIER trials

  • Primary endpoint: Change in BCVA from baseline to Week 48, measured by ETDRS letter score2
  • Disease activity assessments (DAAs): Anatomical and functional parameters used to determine if patients were eligible for and remained on q12w interval2

Select baseline characteristics

  • Simple mean age: 76 years3
  • Simple mean VA: 61 letters read; comparable between treatment arms3
  • Baseline ocular characteristics for study eye were well balanced across treatment arms
  • 73% of patients with unilateral wet AMD2
  • 93% of patients were diagnosed ≤3 months prior to study entry2

Block of text with the words 'Beovu studied in 1,088 patients across centres worldwide3'

 

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HAWK AND HARRIER

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VA is used to describe BCVA as identified in study protocol.
*Patients were eligible for a q12w interval if no disease activity was observed at Weeks 16 and 20.1
Beovu arms in HAWK: 3 mg (n=358), 6 mg (n=360); in HARRIER: 6 mg (n=370).1,2 HARRIER, confirmatory analysis in HAWK only (1-sided p values for superiority of Beovu).1
Comprehensive DAA criteria at Week 16: Decrease in VA of ≥5 letters compared with baseline; decrease in VA of ≥3 letters and CST increase ≥75 µm compared with Week 12; decrease in VA of ≥5 letters due to wet AMD disease activity compared with Week 12; new or worse IRF/IRC compared with Week 12. DAA criteria at Weeks 20, 32 and 44: Decrease in VA of ≥5 letters due to nAMD activity compared with Week 12.1,3
§Baseline characteristics include, VA (letters read), CST-total, presence of fluid (IRF, SRF, sub-RPE), type of CNV and area associated with CNV lesion1,2


AMD, age-related macular degeneration; BCVA, best corrected visual acuity; CNV, choroidal neovascularisation; CST, central subfield thickness; DAA, disease activity assessment; ETDRS, Early Treatment Diabetic Retinopathy Study; IRC, intraretinal cysts; IRF, intraretinal fluid; nAMD, neovascular age-related macular degeneration; q8w, once every 8 weeks, q12w, once every 12 weeks; RPE, retinal pigment epithelium; SRF, subretinal fluid; VA, visual acuity.

References

  1. Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
  2. Novartis data on file. BRODOF20-002 Core Data Sheet; 2019.
  3. Dugel PU et al. Ophthalmology. 2020; 127: 72–84 (Supplementary information).
BEO20-C039c June 2020.
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