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Rishi P Singh, Andreas Weichselberger, Pravin U Dugel; Comparative assessment of anatomical outcomes for nAMD patients treated with brolucizumab and aflibercept: 16-week data from the HAWK and HARRIER studies. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1464.
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HAWK and HARRIER are two phase III, prospective, 96-week, double-masked studies investigating the efficacy and safety of brolucizumab in comparison to aflibercept in patients with neovascular age-related macular degeneration (nAMD). The primary focus of the current analysis was the anatomic outcomes from the first 16 weeks, in which brolucizumab and aflibercept were administered according to an identical treatment regimen.
Patients were randomized 1:1:1 to brolucizumab 3mg (n=358), 6mg (n=360) or aflibercept 2mg (n=360) (HAWK), or 1:1 with either brolucizumab 6mg (n=370) or aflibercept 2mg (n=369) (HARRIER). Only one eye of each patient was designated as the study eye. After three loading doses, brolucizumab patients were treated every 12 weeks (q12w), with the possibility of adjusting to q8 during the first q12 interval and at each scheduled q12 treatment visit. Aflibercept patients were treated on a q8w regimen, as per label. SD OCT assessments were conducted and images were analyzed by independent central reading centers.
The mean change in central subfield thickness (CST) from baseline to week 16 for brolucizumab 6mg was -161.4 µM and for aflibercept 2mg was -133.6 µM (p = 0.0016) in the HAWK study. In HARRIER, the mean CST reduction from baseline to week 16 for brolucizumab 6mg was -174.4 µM and for aflibercept 2mg was -134.2 µM (p <0.0001). At week 16, fewer patients on brolucizumab 6mg had retinal fluid (IRF and/or SRF) relative to aflibercept and the corresponding rates for brolucizumab 6mg were 35% (HAWK) and 33% (HARRIER) lower as compared to aflibercept (p < 0.0001). Fewer brolucizumab 6mg patients had sub-RPE fluid compared to aflibercept patients at week 16, i.e 30% (p = 0.0021) and 33% (p=0.0041) in HAWK and HARRIER as compared to aflibercept, respectively.
The anatomic outcomes upto week 16 from the matched head-to-head period of the phase III HAWK and HARRIER studies provide a valuable comparison of brolucizumab to aflibercept in an identical dosing schedule. Results from this study period demonstrated statistically better anatomical outcomes for brolucizumab compared to aflibercept for the IRF and/or SRF fluid status, retinal thickness and presence of disease activity assessments.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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