Prescribing information

Visual acuity outcomes with Beovu in clinical trials.

Beovu demonstrated non-inferiority vs aflibercept in mean BCVA change from baseline to Week 481,2

  • Visual acuity gains achieved at Week 48 with a majority of patients on a q12w interval1
  • The vision gains were maintained at Week 962
  • In both trials, ~30% of patients gained at least 15 letters with Beovu at Week 481

Graphs showing the mean change in visual acuity over time with Beovu vs aflibercept in the HAWK and HARRIER trials

The primary efficacy endpoint for the studies was the mean change from baseline in BCVA to Week 48 as measured by the ETDRS Letter Score with the primary objective to demonstrate non-inferiority of Beovu vs aflibercept.1 Beovu (q12w/q8w) demonstrated non-inferiority in VA to aflibercept 2 mg (fixed q8w).1

BCVA, best corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; q8w, once every 8 weeks; q12w, once every 12 weeks; VA, visual acuity.

References

  1. Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
  2. Novartis data on file. BRODOF20-001 Core Data Sheet; 2019.
BEO20-C039d June 2020.
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