Reevaluating the Safety of Brolucizumab for Treating Wet Age-Related Macular Degeneration

Ashley Y. Gao; Sophie J. Bakri, MD


March 11, 2022

Age-related macular degeneration (AMD) is a disease of the macula and a leading cause of vision loss.[1] Neovascular AMD, also known as wet AMD, is a type of AMD that is characterized by choroidal neovascularization, which results in the leakage of fluid, lipids, and blood.[1]

In 2019, the US Food and Drug Administration approved the drug brolucizumab (Beovu) for treating wet AMD.[2] Although it displayed promise in its ability to administer the medication at a high concentration,[2] brolucizumab was recently reexamined because of its link to cases of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RO).[3]

After the publication of these findings, a study was launched to assess the incidence of and risk factors for IOI, including RV, and/or RO after treatment with brolucizumab in patients with wet AMD.[4] The study found that the incidence of IOI and/or RO after treatment was about 2.4%, with a history of IOI and/or RO identified as a risk factor for such complications.[4]

Nevertheless, the study was limited in its noninterventional and retrospective nature, precluding the ability to establish a causal relationship between brolucizumab treatment and IOI and/or RO. In addition, as the median follow-up in the study was only 3 months, the study provides a limited evaluation of the long-term safety outcomes associated with brolucizumab treatment. Another concern is that patients with a history of IOI and/or RO may be more diligently monitored for future complications, which may explain why a history of IOI and/or RO was identified as a risk factor for IOI and/or RO after treatment.

These findings call for further investigation into the safety of brolucizumab for treating wet AMD. Interventional studies with longer follow-up periods should be conducted to determine potential causality between brolucizumab and long-term complications including IOI and/or RO.

For now, clinicians should focus on monitoring patients, especially those with a history of IOI and/or RO, for potential complications after brolucizumab treatment for wet AMD. However, more research will be required to establish its long-term safety outcomes.

Ashley Y. Gao is an undergraduate student at the University of Minnesota Twin Cities and is majoring in human physiology.

Sophie J. Bakri, MD, a long-time contributor to Medscape, specializes in diseases and surgery of the retina and vitreous, including age-related macular degeneration. She also undertakes both clinical and translational research in the pathogenesis and treatment of retinal diseases.

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