Purpose: To collect data on efficacy and safety of brolucizumab 6 mg drug product intended for commercialization in patients with neovascular age-related macular degeneration to support comparability to brolucizumab product used in the Phase III HAWK and HARRIER studies.Methods: The HAWK extension study was a 24-week, double-masked, multicenter study of patients with neovascular age-related macular degeneration who completed the 96-week HAWK core study. All patients were planned to receive three intravitreal injections of either brolucizumab 6 mg or aflibercept 2 mg. Key endpoint measures included change in best-corrected visual acuity and central subfield thickness from baseline, and incidence and characteristics of treatment emergent adverse events.Results: Best-corrected visual acuity gain and central subfield thickness reduction observed at the end of the core study were maintained to Week 24 of the extension study. There was no indication of difference in the safety profile of the brolucizumab 6 mg drug product intended for commercialization and the brolucizumab 3 mg or 6 mg drug product used in the Phase III clinical trials.Conclusions: Efficacy and safety with the intended commercial formulation of brolucizumab 6 mg in neovascular age-related macular degeneration patients was consistent with that observed in the Phase III studies.
Keywords: Neovascular age-related macular degeneration; aflibercept; anti-vascular endothelial growth factor therapy; brolucizumab; commercial formulation.