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  • Risk of Adverse Ocular Events With Brolucizumab

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

    Ophthalmology, July 2021

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    Monés et al. conducted an independent safety review of HAWK and HARRIER data to learn more about investigator-reported cases of intraocular inflam­mation, endophthalmitis, and retinal arterial occlusion. This analysis was prompted by postmarketing evidence received by the drug’s manufacturer indi­cating that retinal vasculitis or retinal vascular occlusion occurred in up to 4.71 of every 10,000 injections of brolu­cizumab. The safety committee reported signs of retinal vas­culitis, with or with­out retinal vascular occlusion, which were linked to greater risk of visual acuity (VA) decline. This knowledge should help physicians weigh the risks and benefits of brolucizumab for their patients with neovascular age-related macular degeneration (AMD), said the authors.

    Patients enrolled in HAWK and HARRIER had untreated active cho­roidal neovascularization due to AMD and were assigned randomly to receive brolucizumab or aflibercept. The inde­pendent safety review committee stud­ied the subset of cases of intraocular inflammation that occurred (60/1,088 with brolucizumab, vs. 8/729 with aflibercept) by looking at patient data and imaging studies. Main outcome measures were signs and incidence of VA loss and vasculitis and/or retinal vascular occlusion; time from the initial brolucizumab injection to onset of in­traocular inflammation; and frequency of VA loss after brolucizumab injection by time of inflammation onset.

    In 50 brolucizumab-treated eyes, the intraocular inflammation was definitely or probably related to the study drug, the safety review committee confirmed. The combined rate of definite/proba­ble inflammation was 4.6%, and eight eyes treated with brolucizumab (0.74% overall) had moderate or severe VA loss. In contrast, the incidence of intraocular inflammation among aflibercept-treat­ed eyes was 1.1%, and moderate or severe VA loss occurred in 0.14%.

    The authors encourage close sur­veillance of patients on brolucizumab therapy to ensure prompt recognition of intraocular inflammation, retinal vasculitis, or retinal occlusion. They recommend adding slit-lamp exam­inations, ophthalmoscopy, and fundus imaging to the monitoring protocol.

    The original article can be found here.