Clinical Studies:

HAWK and HARRIER

Ramsey Yusuf, MD; Bascom Palmer Eye Institute, Miami, FL

Citation: Dugel PU, Singh RP, Koh A, et al. Hawk and Harrier: Ninety-six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2021;128(1):89-99.

Key Points

  • HAWK and HARRIER, sponsored by Alcon Research, was designed to compare intravitreal brolucizumab, with an adjustable dosing interval of 12 or 8 weeks, and intravitreal aflibercept, with a fixed dosing interval of 8 weeks, for the treatment of vision loss from neovascularization from age-related macular degeneration.
  • Participants were randomized 1:1:1 to brolucizumab 3 mg, brolucizumab 6 mg, or aflibercept 2 mg (HAWK); and 1:1 to brolucizumab 6 mg or aflibercept 2 mg (HARRIER), being followed every 4 weeks for up to 96 weeks.
  • Patients treated with intravitreal brolucizumab demonstrated noninferior change in best-corrected visual acuity (BCVA) and improved anatomic outcomes compared with those treated with intravitreal aflibercept at 96 weeks.
  • Both brolucizumab and aflibercept were well tolerated with similar safety profiles except for increased incidence of intraocular inflammation with or without retinal vasculitis in eyes treated with brolucizumab.
  • Objective

    To determine whether intravitreal brolucizumab at doses of 3 mg or 6 mg produces noninferior visual benefit and similar safety profile compared with intravitreal aflibercept 2 mg for the treatment of neovascular age-related macular degeneration (nAMD).


    *In the FOCUS trial, all patients received PDT (no ranibizumab-only arm)

  • STUDY DESIGN

    Two similarly designed, phase 3, multicenter, prospective, randomized, double-masked, interventional clinical trials

STUDY SUBJECTS



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RESULTS

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CONCLUSIONS