The clinical trials of Beovu 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 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 the two clinical trials vs aflibercept, Beovu:
- Demonstrated non-inferiority vs aflibercept in mean BCVA change from baseline to Week 481†
- Outperformed aflibercept with superior retinal fluid resolution at Weeks 16 and 481‡
- 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
‡Secondary endpoint in HAWK and HARRIER, confirmatory analysis in HAWK only (1-sided p values for superiority of Beovu).1
AMD, age-related macular degeneration; BCVA, best corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; q12w, once every 12 weeks.
- Dugel PU et al. Ophthalmology. 2020; 127: 72–84.