Retinal Vasculitis or Vascular Occlusion After Brolucizumab for Neovascular Age-Related Macular Degeneration

Wykoff, Charles C.; Matsumoto, Hidetaka; Barakat, Mark; Karcher, Hélène; Lozama, Anthony; Mayhook, Andrew; Oshagbemi, Olorunfemi A.; Zorina, Olessia; Hassan, Tarek; Khanani, Arshad M.; Heier, Jeffrey S.

doi:10.1097/iae.0000000000003769

Cited by 14 publications

(12 citation statements)

References 38 publications

(75 reference statements)

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“…IOI events' onset occurred early, within the rst to the third brolucizumab injection and 7 to 21 days after the last injection (Table 1), which is in accordance with the OCTOPUS and SWIFT trials or in line with a recent review reporting 88% of cases within 30 days, after a mean of 1.7 brolucizumab injections before the event 2,17 . The time to discharge from 2 to 9 weeks, longer when RO was present, was slightly less than what was found in the aforementioned trials.…”

Section: Discussionsupporting

confidence: 86%

“…Brolucizumab is a humanized monoclonal antibody single-chain variable fragment, which pro ciently inhibits all variants of VEGF-A 1 . Its desirable attributes, such as its small molecular weight and excellent solubility, have rendered it immensely attractive to ophthalmologists since these qualities allow the administration of higher doses at longer intervals between intravitreal injections 2 . It was approved on October 7, 2019 by the US Food and Drug Administration (FDA) at a dosage of 6 mg for the treatment of neovascular age-related macular degeneration (nAMD) 3 .…”

Section: Introductionmentioning

confidence: 99%

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Toxicity related with brolucizumab

Campos,

Tomás,

Oliveira

et al. 2024

Preprint

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Introduction: Post-marketing studies identified severe vision-threatening side effects of brolucizumab, including retinal vasculitis (RV) and intraocular inflammation (IOI). Objective: To present the prevalence of IOI related to brolucizumab in our department, including the first reported case of an occlusive RV with retinal vascular occlusion (RO) and severe vision loss related to brolucizumab in Portugal. Results: There were 4 eyes with unilateral IOI related to brolucizumab (3.42%), one (0.85%) presenting uveitis, two (1.71%) vitritis and the last one presenting occlusive RV (0.85%), from a total of 117 eyes that were on brolucizumab therapy. Conclusion: although serious complications from brolucizumab therapy may appear to be rare, they may be distressful for the patient and the ophthalmologist since some of them may lead to irreversible blindness. Moreover, continuous report of serious sight-threatening events is mandatory, since continuous surveillance and evaluation from the regulatory authorities is needed, as it involves health and legal issues.

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Section: Discussionsupporting

confidence: 86%

Section: Introductionmentioning

confidence: 99%

Toxicity related with brolucizumab

Campos,

Tomás,

Oliveira

et al. 2024

Preprint

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“…The current analysis also showed that the risk of an IOI, RV, and/or RO event was affected by age, sex, and prior anti-VEGF therapy. Eyes from male patients were significantly less likely to experience an event than those from female patients, in line with the earlier IRIS Registry and Komodo database findings [ 6 ] and the high proportion of female cases in real-world studies [ 4 , 19 , 20 ]. Furthermore, while the earlier IRIS Registry and Komodo database analysis showed that age and prior anti-VEGF therapy were not associated with an increased risk of any form of IOI and/or RO, the current analysis suggests that treatment-naive eyes were less likely to experience an event than those with prior anti-VEGF therapy and that older age was associated with a reduced risk of an event [ 6 ].…”

Section: Discussionsupporting

confidence: 83%

Real-World Safety Outcomes with Brolucizumab in Neovascular Age-Related Macular Degeneration: Findings from the IRIS® Registry

Zarbin,

MacCumber,

Karcher

et al. 2024

Ophthalmol Ther

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Introduction To assess real-world safety outcomes for adults with neovascular age-related macular degeneration (nAMD) treated with brolucizumab from the US-based IRIS® (Intelligent Research in Sight) Registry. Methods In this retrospective study, 18,312 eyes (15,998 patients) treated with ≥ 1 intravitreal brolucizumab injections between 8 October 2019 (US launch date for brolucizumab) and 7 October 2021 were followed up for ≤ 2 years after first injection (index date). The study assessed the predefined incident ocular adverse events of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RO). Results Overall, 614/18,312 eyes (3.4%) experienced any IOI, RV, and/or RO event. Median (interquartile range [IQR]) time to an event was 84 (42–167) days; 77.4% of events (475/614) occurred within 6 months after index date. Median (IQR) number of brolucizumab injections before an event was 2 (1–4). For eyes with an adverse event and visual acuity (VA) data ( n = 406), median (IQR) change in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from pre-event VA was 0 (− 7 to + 5) at the 6-month follow-up; 50 eyes (12.3%) had a VA loss of 10 or more ETDRS letters. Risk of an event (hazard ratio [95% confidence interval]) was decreased in eyes from male patients (0.61 [0.53–0.71]), from older patients (0.83 [0.76–0.90]), from treatment-naive patients (0.51 [0.38–0.69]), and from patients who started brolucizumab in the second year after launch (0.68 [0.53–0.86] vs. first year). Conclusion In this large real-world brolucizumab safety study, 3.4% of eyes experienced an IOI, RV, and/or RO event. Among eyes that experienced an adverse event for which VA data were available, median ETDRS vision change was 0 letters (IQR − 7 to + 5). Supplementary Information The online version contains supplementary material available at 10.1007/s40123-024-00920-3.

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“…Despite its efficacy, brolucizumab carries an elevated risk of intraocular inflammation that has limited its use. 40 The ranibizumab port delivery system (PDS) is a refillable intravitreal device that is surgically implanted and offers sustained release of drug over 24 weeks. 21 This system has the benefit of avoiding the need for frequent intravitreal injections.…”

Section: Faricimab: Tenaya Lucerne Faretina-amd Truckeementioning

confidence: 99%