Home > Safety Information > Pivotal trial data (HAWK & HARRIER)

HAWK & HARRIER data

The efficacy and safety of Beovu was studied in two prospective, global, head-to-head, Phase III, randomized, double-masked, clinical trials HAWK (NCT02307682) and HARRIER (NCT02434328). The studies involved over 1,800 patients with wet AMD across 400 centers worldwide. The studies were designed to compare intravitreal injections of brolucizumab 6 mg (HAWK and HARRIER) and 3 mg (HAWK only) versus aflibercept 2 mg with the primary endpoint being change in best corrected visual acuity from baseline to Week 48, with patients followed until Week 96. In the HAWK & HARRIER trials, intraocular inflammation and retinal artery occlusive events were reported. Click here to access the primary and Year 2 manuscripts published in Ophthalmology.

Note: Healthcare providers and clinical trial investigators report what they diagnose or observe. In a clinical trial submitted to Health Authorities, the terms reported by investigators are mapped to the closest terms found within a medical coding dictionary.

Safety Review Committee report

The Safety Review Committee (SRC) conducted an unmasked review of a subset of imaging data from HAWK & HARRIER and reclassified some of the adverse events as “retinal vasculitis” and/or “retinal vascular occlusion”. They found that these events occurred on a spectrum ranging from intraocular inflammation to vasculitis to occlusive events that sometimes resulted in vision loss.

The Safety Review Committee (SRC) has provided a preliminary report of their unmasked, independent analysis of brolucizumab Phase III trials (HAWK & HARRIER) adverse events. The report can be downloaded here.