Drug updated on 9/4/2024
Dosage Form | Injection (intravitreal; 6 mg/0.05 mL) |
Drug Class | Vascular 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).
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Beovu (brolucizumab–dbll) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |