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The clinical trials of ▼Beovu® (brolucizumab) and its efficacy in wet AMD.

HAWK and HARRIER: prospective head-to-head trials of Beovu with q12w/q8w intervals* vs aflibercept q8w1

The efficacy and safety profile of Beovu was assessed in two randomised, multicentre, double-masked, active-controlled Phase III studies (HAWK and HARRIER) in 1,088 wet AMD patients across centres worldwide.1  Learn more about the study design.

In these two clinical trials, Beovu:

  • Demonstrated non-inferiority vs aflibercept in mean BCVA change from baseline to Week 48
  • Achieved fluid resolution (absence of SRF, IRF and Sub-RPE fluid) in more patients compared to aflibercept at Weeks 16 and 48 (post-hoc analysis)
  • Maintained a majority of patients on a q12w interval immediately after loading through Week 481

*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
In both studies, the primary efficacy endpoint was non-inferiority in mean BCVA change from baseline to Week 48 as measured by ETDRS. Visual acuity gains were achieved with 56% and 51% of patients treated with Beovu on q12w interval at Week 48 in HAWK and HARRIER, respectively.1
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 [HAWK: brolucizumab 6 mg (n=360), aflibercept 2 mg (n=360); HARRIER: brolucizumab 6 mg (n=370), aflibercept 2 mg (n=369)]; p<0.0001].1

AMD, age-related macular degeneration; BCVA, best corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; IRF, intraretinal fluid; RPE, retinal pigment epithelium; SRF, subretinal fibrosis; q12w, once every 12 weeks.

Reference

  1. Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
  2. Singh RP et al. ARVO Annual Meeting 2019.
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UK | October 2021 | 154311
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