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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 dossier of clinical trial data submitted to Health Authorities, the terms reported by investigators are mapped to the closest terms found within an international standardized 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.