Brolucizumab–dbll

(Beovu®)

Beovu®

Drug updated on 9/4/2024

Dosage FormInjection (intravitreal; 6 mg/0.05 mL)
Drug ClassVascular endothelial growth factor inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).
  • Indicated for the treatment of diabetic macular edema (DME).

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Summary
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  • Beovu (brolucizumab-dbll) is indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD) and the treatment of diabetic macular edema (DME).
  • This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
  • Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR): Brolucizumab significantly improved Best-Corrected Visual Acuity (BCVA) (MD -0.64 mu, 95% CI [-1.15, -0.13], P=0.01) and reduced Central Subfield Macular Thickness (CSMT) (MD -138.6 mu, 95% CI [-151.9, -125.3], P=0.00001).
  • Neovascular Age-Related Macular Degeneration (nAMD): Brolucizumab provided comparable or superior BCVA gains and showed greater retinal thickness reduction than aflibercept and ranibizumab over 1 and 2 years.
  • Recalcitrant nAMD: Switching to brolucizumab significantly reduced Central Subfield Thickness (CST) but resulted in a clinically irrelevant decrease in BCVA.
  • General Anti-VEGF Comparison for nAMD: Brolucizumab was non-inferior to other anti-VEGF agents in improving BCVA and induced higher CST reduction compared to aflibercept.
  • Brolucizumab was associated with an increased incidence of serious ocular adverse events, particularly retinal vasculitis and vascular occlusion, compared to aflibercept and ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
  • In diabetic macular edema (DME) and diabetic retinopathy (DR), the 3 mg dose of brolucizumab had a higher frequency of adverse events, including retinal vasculitis, compared to the 6 mg dose.
  • Real-world data indicated that retinal vasculitis or vascular occlusion events occurred with a mean time to event of 19.4 days, and about half of the affected eyes experienced vision loss.
  • The reviewed evidence indicates that brolucizumab was particularly effective in diabetic patients with DME and DR, with specific consideration given to elderly women, who were the majority of the study population and experienced a higher rate of retinal vasculitis or vascular occlusion (RV/RO) events, suggesting a potentially increased risk in this subgroup. Additionally, patients with recalcitrant nAMD, who switched to brolucizumab after other anti-VEGF treatments failed, demonstrated notable outcomes, though with some safety concerns.

Product Monograph / Prescribing Information

Document TitleYearSource
Beovu (brolucizumab–dbll) Prescribing Information.2023Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Safety and efficacy of brolucizumab in the treatment of diabetic macular edema and diabetic retinopathy: a systematic review and meta-analysis.2024Seminars in Ophthalmology
Efficacy and safety of brolucizumab, aflibercept, and ranibizumab for the treatment of patients with visual impairment due to diabetic macular oedema: a systematic review and network meta-analysis.2023Diabetes Therapy
Retinal vasculitis or vascular occlusion after brolucizumab for neovascular age-related macular degeneration: a systematic review of real-world evidence.2023Retina
Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis.2023Cochrane Database Systematic Reviews
Brolucizumab in pretreated neovascular age-related macular degeneration: case series, systematic review, and meta-analysis.2023Life
The efficacy and safety of brolucizumab for the treatment of nAMD: a systematic review and meta-analysis.2022Frontiers in Pharmacology
Comparative efficacy of brolucizumab in the treatment of neovascular age-related macular degeneration: a systematic literature review and network meta-analysis.2022Advances in Therapy
Managing neovascular age-related macular degeneration in clinical practice: systematic review, meta-analysis, and meta-regression.2022Journal of Clinical Medicine
Anti-vascular endothelial growth factor therapy for age-related macular degeneration: a systematic review and network meta-analysis.2021Systematic Reviews
Effect of anti‐VEGF therapy on the disease progression of neovascular age‐related macular degeneration: a systematic review and model‐based meta‐analysis.2021Journal of Clinical Pharmacology
Disease stability and extended dosing under anti-VEGF treatment of exudative age-related macular degeneration (AMD) — a meta-analysis.2021Graefe's Archive for Clinical and Experimental Ophthalmology