Novartis’ Beovu (brolucizumab) Receives FDA’s Approval for the Treatment of Wet Age-Related Macular Degeneration

Novartis’ Beovu (brolucizumab) Receives FDA’s Approval for the Treatment of Wet Age-Related Macular Degeneration

Shots:

  • The approval is based on P-III HAWK (NCT02307682) & HARRIER (NCT02434328) studies involves assessing of Beovu (intravitreal injection), 6mg (HAWK and HARRIER) & 3mg (HAWK) vs Aflibercept (2mg) in 1,800+ patients with wet AMD across 400 centers globally
  • The P-III studies demonstrated non-inferiority in mean change BCVA @1yr. (week 48); reductions in central subfield thickness, @1yr. 56% & 51% maintained on the 3mos. dosing interval
  • Beovu (RTH258) is the only anti-VEGF in wet AMD recommended to maintain eligible patients on up to 3mos. dosing intervals immediately after loading phase with no compromise in efficacy

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