Brolucizumab for the treatment of diabetic macular edema

Abstract

Purpose of reviewTo review the available data supporting the use of brolucizumab in the treatment of diabetic macular edema (DME).Recent findingsBrolucizumab is a humanized single- chain variable antibody fragment (scFv), the smallest functional subunit of an antibody approved for intravitreal use. Three phase III studies demonstrate that at 52 weeks, brolucizumab has statistically superior anatomical outcomes of reducing retinal thickness (54.0–57.5% of brolucizumab treated eyes achieved central subfield thickness <280 μm compared to 40.1 – 41.4% of aflibercept treated eyes) and retinal fluid (present in 54.2–60.3% of brolucizumab treated eyes compared to 72.9–78.2% of aflibercept treated eyes). Brolucizumab also demonstrated a prolonged durability up to 16 weeks, thus reducing treatment burden. The visual outcomes appear noninferior to current anti-VEGF agents with an increased risk for intraocular inflammatory events (0.3–4.7% compared to 0.6–1.7%).SummaryResults from recent phase III trials showing the efficacy and safety of brolucizumab presents an additional therapeutic option in the DME treatment landscape. It can reduce treatment burden in DME with increased inter-treatment intervals while conferring efficacy in both functional and anatomical outcomes. Caution should be taken regarding the risks of intraocular inflammation, retinal vasculitis, and retinal vascular occlusion.

Advancements in the Treatment of Diabetic Macular Edema: Current Strategies and Future Directions

“…These range from 0.05% to 2.1% for aflibercept, 0.05% to 1.1% for bevacizumab, and 0.005% to 1.9% for ranibizumab. In contrast, it reaches 4.4% for brolucizumab 22 .…”

“…Brolucizumab, a relatively novel anti-VEGF agent for the treatment of DME, has demonstrated efficacy in reducing macular thickness and has shown significant potential in improving best-corrected visual acuity (BCVA) and central subfield macular thickness (CSMT) in patients with DME 21 . Furthermore, it is possible that fewer injections may be required compared to other anti-VEGF agents 21,22 . The efficacy of brolucizumab has been demonstrated to persist for up to 16 weeks, thereby reducing the treatment burden 22 .…”

“…Furthermore, it is possible that fewer injections may be required compared to other anti-VEGF agents 21,22 . The efficacy of brolucizumab has been demonstrated to persist for up to 16 weeks, thereby reducing the treatment burden 22 . The safety profile of brolucizumab has been evaluated, revealing a relatively low incidence of adverse effects, with retinal vasculitis and retinal vascular occlusion being the most concerning 21 .…”

Optimizing treatment for diabetic macular edema during cataract surgery

“…Intraoperative aflibercept did not exert a significant effect on postoperative CMT or visual acuity at 3 months, probably due to a relatively shorter half-life ( 65 ). To date, there are no clinical trials yet examining the role of intraoperative injection of newer anti-VEGF agents, such as brolucizumab and faricimab on DMR, but their safety profiles and efficacies on DME were demonstrated in clinical trials ( 66 , 67 ). Nevertheless, intravitreal anti-VEGF still remains the well-established first-line treatment for preoperative DME ( 68 , 69 ).…”

Flare levels after intravitreal injection of brolucizumab for diabetic macular edema

“…The KESTREL and KITE studies demonstrated that intravitreal injection of brolucizumab (IVBr) was effective in the robust gain of visual acuity and anatomical improvement [ 9 ]. Moreover, the intervals of brolucizumab injection are prolonged up to 16 weeks; thus, the treatment burden on patients may be reduced [ 10 ].…”