TY - JOUR
T1 - HAWK Extension Study
T2 - Safety and Efficacy of Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration
AU - on behalf of the HAWK Extension Study Investigators
AU - Brown, David M.
AU - Nowik, Marta
AU - Bouillaud, Emmanuel
AU - Dugel, and Pravin U.
N1 - Funding Information:
Medical writing support under the guidance of the authors was provided by Carol Crawford, Mark Kirby, and Susan Browne at Novartis Ireland Ltd. in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). Medical writing support was funded by Novartis Pharma AG.
Publisher Copyright:
© 2022 The Author(s). Published with license by Taylor & Francis Group, LLC.
PY - 2023/1
Y1 - 2023/1
N2 - 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.
AB - 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.
KW - aflibercept
KW - anti-vascular endothelial growth factor therapy
KW - brolucizumab
KW - commercial formulation
KW - Neovascular age-related macular degeneration
KW - Receptors, Vascular Endothelial Growth Factor/therapeutic use
KW - Intravitreal Injections
KW - Humans
KW - Antibodies, Monoclonal, Humanized/therapeutic use
KW - Macular Degeneration/drug therapy
KW - Wet Macular Degeneration/diagnosis
KW - Visual Acuity
KW - Recombinant Fusion Proteins/therapeutic use
KW - Angiogenesis Inhibitors/therapeutic use
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U2 - 10.1080/02713683.2022.2096907
DO - 10.1080/02713683.2022.2096907
M3 - Article
C2 - 36398628
AN - SCOPUS:85142346430
SN - 0271-3683
VL - 48
SP - 44
EP - 50
JO - Current Eye Research
JF - Current Eye Research
IS - 1
ER -