Abstract
Purpose :
Brolucizumab (Beovu) is a novel anti-vascular endothelial growth factor (VEGF) drug approved for the treatment of neovascular age-related macular degeneration (NVAMD). In this post-marketing surveillance study, we evaluated the efficacy and safety of brolucizumab in our practice during the initial 7.5 months following its commercial release.
Methods :
Retrospective consecutive case series of 544 patients with NVAMD who were treated with intravitreal injections (IVI) of brolucizumab in a private retina practice between 10/1/2019 and 5/15/2020. The study population included NVAMD patients who were treatment-naive and others who were switched from an alternate anti-VEGF therapy. Visual acuity (VA) was compared before initiation of brolucizumab therapy and at the end of the study period. Anatomic outcomes were assessed with spectral-domain optical coherence tomography and included central subfield thickness (CST), macular volume (MV), presence of intraretinal fluid (IRF), presence of subretinal fluid (SRF), and presence of serous pigment epithelial detachment (sPED) on foveal line scans. The cumulative incidence of drug-related adverse effects during the study period was also reported.
Results :
544 patients received a total of 1438 brolucizumab IVIs during the study period. A statistically significant improvement in VA was observed in treatment-naïve eyes (+3.7 letters, p=0.038) but not in eyes switched from another anti-VEGF agent (-0.5 letters, p=0.41). For both groups of patients, there were significant reductions in CST (-47.8µm), MV (-0.40mm3), presence of IRF (-18.5%), presence of SRF (-28.6%), and presence of sPED (-7.3%; all p<0.001). Drug-related adverse events occured in 26 patients (4.8%), including intraocular inflammation (25), retinal vasculitis (3), retinal artery occlusion (1), and urticarial rash (1) after an average of 2.0 IVIs.
Conclusions :
Brolucizumab proved to be a potent drying agent in both treatment-naive and previously anti-VEGF treated eyes. However, no VA improvement was observed when eyes were switched to brolucizumab from an alternate anti-VEGF agent. The incidence of brolucizumab-related inflammatory events observed in this post-marketing surveillance study corroborates a recent reanalysis of clinical trial data by the Safety Review Committee.
This is a 2021 ARVO Annual Meeting abstract.