Brolucizumab noninferior to aflibercept in improving visual acuity in age-related macular degeneration

USA: Visual acuity outcomes in participants previously treated with neovascular age-related macular degeneration (n-AMD) and persistent retinal fluid receiving brolucizumab 6 mg every 4 weeks were not inferior to aflibercept 2 mg administered every 4 weeks, with resolution higher surgery, says a study published in Ophthalmology.

This study was performed by Arshad M Khanani and his team To evaluate the 52-week efficacy and safety of brolucizumab 6 mg administered every 4 weeks (q4w) compared with aflibercept 2 mg dosed every 4 days in the eye with nAMD and persistent retinal fluid.

This study was a randomized, double-blind, multicenter phase 3a study in which participants had persistent AMD (residual retinal fluid that persists despite regular treatment). previously with anti-molecular endothelial growth factor) were included in the trial. The intervention in this study was the eye, randomized (2:1) to receive intra-gastric brolucizumab 6 mg or aflibercept 2 mg every 4 weeks up to and including week 100.

The primary endpoint was analytic equal magnitude of mean change for best-corrected visual acuity Week 52 (margin: 4 letters). Other important endpoints included change in central subfield thickness (CST) from baseline to week 52, fluid-free status (no intracerebral fluid [IRF], and absence of underlying fluid). urethral [SRF]) and safety status.

The key findings of this study were as follows:

1. At 52 weeks, brolucizumab was not inferior to aflibercept in change from baseline in BCVA (least mean difference 0.6 ETDRS letters).

2. Stabilization or improvement of vision (no worse than 5 letters BCVA loss) occurred at a comparable, as did an increase of ≥15, ≥10 and ≥5 letters (brolucizumab: 16.9%, 22.3%, and 35.8%, respectively; aflibercept: 17.4%, 20.2%, and 31.5%, respectively).

3. A total of 4.8% and 1.7% of participants reported a letter loss of ≥15 BCVA from baseline at week 52 in the brolucizumab and aflibercept groups, respectively.

4. In the eyes treated with brolucizumab compared with those treated with aflibercept, CST was significantly reduced (P < 0.001) and the percentage of fluid-free eyes was significantly higher at week 52 (40.4% brolucizumab vs. 19.0 ± libercept; 95% CI: 13.9 (29.0; P < 0.001)

5. The incidence of intraocular inflammation (IIO), including retinal vasculitis and retinal vascular occlusion, was 9, respectively. .3% (0.8% and 2.0%) for brolucizumab compared with 4.5% (0% and 0%) for aflibercept.

Reference:

Khanani, A. M., Brown, D. M., Jaffe, G. J., Wykoff, C. C., Adiguzel, E., Wong, R., Meng, X., & Heier, J. S. (2022). MERLIN: Phase 3a, Multicenter, Randomized, Double-Masked Trial of Brolucizumab in Participants With nAMD and Persistent Retinal Fluid. In Ophthalmology. Elsevier BV. https://doi.org/10.1016/j.ophtha.2022.04.028