Prescribing information

Anatomical outcomes with Beovu in clinical trials.

Superior retinal fluid resolution vs aflibercept1,2

  • Beovu outperformed aflibercept, with significantly fewer patients with IRF and/or SRF at Weeks 16 and 481
  • The difference was maintained at Week 962

 

Graphs showing the percentage of patients with IRF and/or SRF at Weeks 16, 48 and 96 on Beovu vs aflibercept in the HAWK and HARRIER trials

Early superior CST reductions vs aflibercept1,2

  • Beovu outperformed aflibercept with superior CST reductions at Week 16, with similar results observed at Week 481*
  • The difference was maintained at Week 96 (p=0.0115 in HAWK, p<0.0001 in HARRIER)2†

 

Graphs showing CST reductions from Week 0 to Week 96 for Beovu vs aflibercept in the HAWK and HARRIER trials

 

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).1,2
Secondary endpoints in HAWK and HARRIER; 2-sided p values.1

BCVA, best corrected visual acuity; CST, central subfield thickness; ETDRS, Early Treatment Diabetic Retinopathy Study; IRF, intraretinal fluid; LS, least squares; SRF, subretinal fluid.

References

  1. Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
  2. Novartis data on file. BRODOF20-001 Core Data Sheet.
BEO20-C039e June 2020.
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