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  • Brolucizumab Outcomes at 96 Weeks

    By Lynda Seminara
    Selected By: Stephen D. McLeod, MD
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    Journal Highlights

    Ophthalmology, January 2021

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    Brolucizumab, a novel VEGF inhibitor with an extended dosing schedule, is under evaluation as a treatment for neo-vascular age-related macular degener­ation (AMD). In the phase 3 HAWK and HARRIER studies, brolucizumab showed noninferior efficacy and safety relative to aflibercept at the 48-week mark. Continuing this work, Dugel et al. noted persistence of these favorable outcomes to week 96. In addition, gains in best-corrected visual acuity (BCVA) were comparable for the two agents, and anatomic outcomes were better with brolucizumab.

    In the original research, treatment-naive eyes with wet AMD were assigned randomly (1:1:1) to receive either brolucizumab 3 mg (n = 358), brolucizumab 6 mg (n = 360), or aflibercept 2 mg (n = 360) in HAWK and 1:1 to brolucizumab 6 mg (n = 370) or aflibercept 2 mg (n = 369) in HARRIER. After three loading doses, brolucizumab was given every 12 weeks (q12w), with a switch to every eight weeks (q8w) based on disease activity assessments. Aflibercept was dosed q8w throughout.

    The early visual gains in both studies were maintained through week 96. In HAWK, changes in BCVA (least squares [LS] mean ± standard error) from baseline to week 96 were 5.6 ± 0.79 and 5.9 ± 0.78 letters for brolucizumab 3 mg and 6 mg, respectively, and 5.3 ± 0.78 letters for aflibercept. In HARRIER, the changes were 6.1 ± 0.73 letters with brolucizumab 6 mg and 6.6 ± 0.73 letters with aflibercept. Reductions in central subfield thickness were greater with brolucizumab 6 mg than with aflibercept: LS mean, ‒174.8 μm vs. ‒148.7 μm (p = .0115), respectively, in HAWK and ‒197.7 μm vs. ‒155.1 μm (p < .0001), respectively, in HARRI­ER. At week 96 of HAWK, intraretinal and/or subretinal fluid was present in significantly fewer eyes treated with brolucizumab (31% [p = .0688] with 3 mg and 24% [p =.0002] with 6 mg) than with aflibercept (37%); in HAR­RIER, fluid was present in 24% of eyes treated with brolucizumab 6 mg (p < .0001) and in 39% of aflibercept-treat­ed eyes. The probability of maintaining a q12w regimen for brolucizumab 6 mg at last disease assessment was 45.4% in HAWK and 38.6% in HARRIER. Over­all, brolucizumab was well tolerated.

    These longer-term outcomes suggest that brolucizumab may improve disease control while lightening the treatment burden of neovascular AMD.

    The original article can be found here.