1. Medicines
  2. Ophthalmology
  3. ▼ BEOVU® (brolucizumab)
  4. Clinical trials
  5. Study design

Prescribing information

Study design

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 arms3§
  • 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'

 

Image of the HAWK and HARRIER summary document

HAWK AND HARRIER

Download a handy one-page summary document on HAWK and HARRIER

Download

 

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.
Ophthalmology
×

Ask Speakers

×

Medical Information Request

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]