Prescribing information

The impact of Beovu on functional and anatomical parameters in wet AMD.

Less patients with disease activity vs aflibercept1,2

In the HAWK and HARRIER Phase III trials, ‘disease activity’ was used to describe the anatomical and functional outcomes measured in wet AMD patients. The disease activity assessment at Week 16 included visual acuity, central retinal thickness, IRF/SRF and sub-RPE fluid.1,2

At Week 16:

  • 24% of Beovu patients had disease activity vs 35% of aflibercept patients in HAWK1,2
  • 23% of patients with Beovu had disease activity vs 32% of aflibercept patients in HARRIER1,2

 

Block of text with the words 'With Beovu 30% fewer patients had disease activity than with aflibercept in both trials at Week 16 (p=0.001; p=0.002)1*'

 

 

Learn more about disease activity assessments in our study design.

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
*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; IRF, intraretinal fluid; RPE, retinal pigment epithelium; SRF, subretinal fluid.

References

  1. Dugel PU et al. Ophthalmology. 2020; 127:72–84.
  2. Beovu Summary of Product Characteristics, 2020.
BEO20-C039f June 2020.
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