Real-World Data Exhibit Efficacy of Brolucizumab in nAMD Treatment

Michael Singer, MD

A new systematic literature of real-world clinical practice indicated the efficacy of brolucizumab in treatment-naive and previously anti-VEGF-treated patients with neovascular age-related macular degeneration (nAMD).

The study data suggest brolucizumab was linked to reduction in disease activity in anti-VEGF switch eyes, demonstrated by fluid reduction and/or visual acuity gain, as well as prolongation of the interval between injections.

“Our systematic review provides insights into brolucizumab treatment in everyday clinical practice, in scenarios that may not be assessed in the pivotal trials,” wrote study author Michael Singer, MD, MD, University of Texas Health Science Center and Medical Center Ophthalmology.

The introduction of anti-VEGF agents have revolutionized patient care in reducing vision loss, including a reduction in pathologic exudation, intraretinal fluid (IRF), and/or subretinal fluid (SRF) from macular neovascularization.

Previously, phase 3 data from the HAWK and HARRIER trials on brolucizumab met the primary endpoint and demonstrated that anti-VEGF therapy was noninferior to aflibercept in best-corrected visual acuity gains (BCVA) and led to superior anatomical outcomes.

The current systematic review aimed to summarize the published real-world, post-approval efficacy and safety data on brolucizumab in treatment-naive and anti-VEGF switch patients with nAMD. Outcome reports of efficacy and/or safety in individuals receiving brolucizumab to treatment nAMD in clinical practice were eligible.

Overall, a total of 26 studies described at least 10 brolucizumab-treated eyes and were included in the main descriptive summary. The studies included a total number of 2907 eyes. Regarding outcomes, 16 studies reported data for eyes switched to brolucizumab, eight studies for treatment-naive and switch eyes combined, and six studies for treatment-naive eyes.

A total of six studies on treatment-naive eyes reported an improvement in BCVA, which was considered significant in four studies (P <.05). The mean BCVA improvement ranged from +3.7 (P = .038)  to +11.9 (P = .011) Early Treatment Diabetic Retinopathy study (ETDRS) letters in these four studies.

From 12 studies on switch eyes, a total of 3 studies reported significant improvement in mean BCVA in switch eyes. The improvements were reported as +9.0 ETDRS letters (P <.001) and achieved significance at 16 weeks (+15 ETDRS letters; P = .03). All remaining studies reported no significance in post-brolucizumab BCVA changes.

Further, six studies reported a significant reduction in mean CST from brolucizumab initiation to follow-up in treatment-naive eyes. The improvements ranged from -113.4 μm (P <.001) to -150.1 μm (P = .021). Moreover, a total of 8 studies observed significant improvement in mean CST in switch eyes, ranging from -26 μm to -185.7 μm (P = .01).

Investigators indicated data on the presence of total fluid, IRF, and/or SRF at baseline and follow-up were reported in 14 studies. A total of 10 studies on the presence of IRF observed an improvement at follow-up compared with baseline, while 12 studies reported a reduction in the proportion of eyes with SRF present at follow-up compared with baseline.

Meanwhile, four studies compared treatment intervals with previous anti-VEGF treatment and treatment intervals after switching to brolucizumab, with all observing an extension of the treatment interval. Investigators noted that the incidence of intraocular inflammation (IOI) ranged from 0% to 19% after initiation of brolucizumab.

The study, “Efficacy and safety of brolucizumab in age-related macular degeneration: A systematic review of real-world studies,” was published in Acta Ophthalmologica.