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Rishi P Singh, Robin Hamilton, Jeffrey S Heier, Carl Regillo, Mark C Gillies, Georges Weissgerber, Jahangir Alam, Pravin U Dugel; Disease Activity Assessments with Brolucizumab vs Aflibercept in Patients with nAMD in HAWK and HARRIER. Invest. Ophthalmol. Vis. Sci. 2020;61(7):1158.
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To compare the presence of disease activity (DA) over 96 weeks in HAWK and HARRIER, two Phase III, prospective trials that assessed the efficacy and safety of brolucizumab (Bro) vs aflibercept (Afl) in treatment-naïve patients with nAMD.
Patients were randomized 1:1:1 to Bro 3mg (n=358), 6mg (n=360) or Afl 2mg (n=360) in HAWK, or 1:1 to Bro 6mg (n=370) or Afl 2mg (n=369) in HARRIER. After 3 monthly loading doses, Bro patients received 12-week (q12w) dosing unless DA was present (as identified by masked investigator) at any predefined disease activity assessment (DAA) visit and resulted in permanent 8-week (q8w) dosing; Afl was dosed at fixed q8w. DAA occurred at Weeks 16, 20, 32, 44, 56, 68, 80, 92 with additional DAA at Weeks 28, 40, 52, 64, 76, and 88 in HARRIER only. All patients continued with planned DAA until the study end based on DAA guidance described in the study protocol, where ultimately the masked investigator took the final treatment decision based on their clinical judgment. The first DAA at Week 16 allowed for head-to-head comparison between treatment arms for q8w dosing need.
At Week 16, DA presence and therefore q8w dosing need was statistically significantly lower with Bro vs Afl in both HAWK (Bro 3mg=28.1%; Bro 6mg=24.0% vs Afl=34.5%; p<0.03 for both) and HARRIER (Bro 6mg=22.7% vs Afl=32.2%; p=0.002). DA presence was higher with Afl vs Bro (HAWK/HARRIER: Afl=22.2% / 19.6% vs Bro 3mg=14.9% / 0%; Bro 6mg=13.6% / 15.7%) across all DAA from Week 16 through 96. Further, qualitative analysis of all DAA in HAWK/HARRIER showed that across all treatment arms (given the masked investigator assessment), in 71.4% / 67.7% of the cases anatomical signs of DA were present either alone (35.8% / 41.9%) or in combination with function (35.6% / 25.8%).
Together, the functional and anatomical DA evaluations in HAWK and HARRIER indicate that nAMD patients treated with Bro 6mg q12w/q8w have lower risk of DA occurrence than Afl and thereby better disease control.
This is a 2020 ARVO Annual Meeting abstract.
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