Ocular adverse events following intravitreal brolucizumab for neovascular age-related macular degeneration at a single tertiary care center

Nguyen, Huy; Li, Angela S.; Silva, Amila R; Leng, Theodore

doi:10.1177/11206721211059332

Cited by 11 publications

(11 citation statements)

References 18 publications

(55 reference statements)

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“…Although the incidence of adverse events in brolucizumab was similar to that in the controls, brolucizumab caused more serious ocular adverse events than Lucentis and aflibercept. This result was consistent with existing studies showing that brolucizumab can cause severe intraocular inflammation (Monés et al, 2021;Motevasseli et al, 2021;Nguyen et al, 2021;Khanani et al, 2022).…”

Section: Discussionsupporting

confidence: 93%

The Efficacy and Safety of Brolucizumab for the Treatment of nAMD: A Systematic Review and Meta-Analysis

et al. 2022

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Introduction: As demonstrated in pivotal clinical trials, brolucizumab can be used to treat neovascular age-related macular degeneration (nAMD) because it antagonizes vascular endothelial growth factor (VEGF) in the vitreous. However, brolucizumab may cause retinal vasculitis obliterans in the presence of inflammation in the eyes. In the present study, a meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate the efficacy and safety of brolucizumab.Methods:ClinicTrail.gov., Embase, Cochrane Library, and PubMed were retrieved from inception until 31 December 2021 for RCTs assessing the efficacy and safety of brolucizumab. Changes in best corrected visual acuity (BCVA) and central sub-field thickness (CSFT) and incidence of adverse events, serious adverse events, and serious ocular adverse events were extracted from eligible RCTs. A meta-analysis was performed using RevMan 5.4.1.Results: A total of six RCTs with 3,574 participants were finally involved in this meta-analysis. The changes of best corrected visual acuity (BCVA) showed no statistically significant difference between the brolucizumab-treated group and aflibercept-treated group. Brolucizumab induced higher central sub-field thickness (CSFT) reduction than the control agent (aflibercept). The incidence of adverse events was similar between the brolucizumab group and control group (OR 0.63, 95% CI 0.37 to 1.08, p = 0.09), and brolucizumab caused fewer serious adverse events (OR 0.78, 95% CI 0.63 to 0.95, p = 0.01). However, brolucizumab could lead to more serious ocular adverse events than Lucentis and aflibercept (OR 2.15, 95% CI 1.11 to 4.16, p = 0.02).Conclusion: Brolucizumab was non-inferior to other anti-VEGF agents in improving BCVA and decreasing CSFT. But it caused more serious ocular adverse events which is worthy of special attention by ophthalmologists.

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Section: Discussionsupporting

confidence: 93%

The Efficacy and Safety of Brolucizumab for the Treatment of nAMD: A Systematic Review and Meta-Analysis

et al. 2022

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“…Nguyen et al first published a case series of ocular adverse events from intravitreal brolucizumab. 82 Two cases of anterior uveitis (1.7%) were recorded, one case of panuveitis with retinal vasculitis (0.9%) and one case of central retinal artery occlusion (0.9%), while the total prevalence of ocular adverse effects was 3.5%. Although the sample size was small, their results were comparable to those presented in the HAWK trial.…”

Section: Safety and Tolerabilitymentioning

confidence: 94%

“…It has been also hypothesised that vascular occlusion could result from a type IV hypersensitivity reaction, where an intravascular inflammatory response occurs along the vessel wall, bringing the plasma in contact with the brolucizumab molecule. 82 …”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Brolucizumab for the Treatment of Degenerative Macular Conditions: A Review of Clinical Studies

Karasavvidou¹,

Tranos²,

Panos³

2022

DDDT

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Age-related macular degeneration (AMD), diabetic retinopathy and retinal vein occlusion represent some of the commonest degenerative conditions that lead to severe vision impairment in the developed countries. The gold standard treatment of complications associated with these conditions is the intravitreal administration of anti-vascular endothelial growth factor (VEGF) agents. Brolucizumab is a newly developed, humanised, single-chain fragment of a monoclonal antibody binding all VEGF-A isoforms, which was recently approved for the treatment of neovascular AMD. Intravitreal brolucizumab promises to reduce treatment burden for nAMD patients by achieving comparable therapeutic outcomes with fewer clinic visits. Promising also appears its use for the treatment of more challenging maculopathies like diabetic macular oedema (DMO). The aim of this review is to describe the special pharmacological properties of brolucizumab and display the outcomes of the most important clinical trials and real-world studies regarding its efficacy and safety for the management of degenerative macular disorders.

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“…Some cases of IOI occurred between 5 days and 20 weeks after injection, whereas RV has been described Review on the Safety and Efficacy of Brolucizumab between 7 and 56 days afterward. 48,61,63 In both databases, more than 80% of total events occurred after either the first or second injection. 55 These findings are also congruent with case reports by Jain and colleagues and Nguyen and colleagues and previous data describing treatment-naive eyes, with ~50% of cases occurring within 3 months of the first injection and ~75% occurring within 6 months of the first injection.…”

Section: Adverse Events/intraocular Inflammationmentioning

confidence: 99%

Review on the Safety and Efficacy of Brolucizumab for Neovascular Age-Related Macular Degeneration From Major Studies and Real-World Data

Radke

Mohamed

Brown

et al. 2023

Asia-Pacific Journal of Ophthalmology

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Frequent antivascular endothelial growth factor injections in neovascular age-related macular degeneration (nAMD) often lead to poor compliance and suboptimal outcomes. A longer-acting agent has been a pressing unmet need until recently. Brolucizumab, an antivascular endothelial growth factor agent, is a single-chain antibody fragment approved by the US Food and Drug Administration (FDA) on October 8, 2019, for treating nAMD. It delivers more molecules at equivalent volumes of aflibercept, thus achieving a longer-lasting effect. We reviewed literature published in English between January 2016 and October 2022 from MEDLINE, PubMed, Cochrane database, Embase, and Google scholar using the keywords: “Brolucizumab, real-world data, intraocular inflammation (IOI), safety, and efficacy”. Brolucizumab showed reduced injection frequency, better anatomic outcomes, and noninferior vision gains compared with aflibercept in HAWK and HARRIER studies. However, post hoc studies on brolucizumab revealed a higher-than-expected incidence of IOI, leading to the early termination of 3 studies: MERLIN, RAPTOR, and RAVEN for nAMD, branch retinal vein occlusion, and central retinal vein occlusion, respectively. Contrastingly real-world data showed encouraging outcomes in terms of fewer IOI cases. The subsequent amendment of the treatment protocol resulted in reduced IOI. Thereafter US FDA approved its use in diabetic macular edema on June 1, 2022. Based on major studies and real-world data, this review shows that brolucizumab is effective for treating naive and refractory nAMD. The risk of IOI is acceptable and manageable, but proper preinjection screening and high-vigilance care of IOI are needed. More studies are warranted to evaluate further the incidence, best prevention, and treatment measures for IOI.

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Ocular adverse events following intravitreal brolucizumab for neovascular age-related macular degeneration at a single tertiary care center

Cited by 11 publications

References 18 publications

The Efficacy and Safety of Brolucizumab for the Treatment of nAMD: A Systematic Review and Meta-Analysis

The Efficacy and Safety of Brolucizumab for the Treatment of nAMD: A Systematic Review and Meta-Analysis

Brolucizumab for the Treatment of Degenerative Macular Conditions: A Review of Clinical Studies

Review on the Safety and Efficacy of Brolucizumab for Neovascular Age-Related Macular Degeneration From Major Studies and Real-World Data

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