A recent 52-week phase 3 clinical trial published in the Journal of American Medical Association compared the efficacy and safety of brolucizumab against aflibercept to enhance treatment options for diabetic macular edema (DME). Regardless the effectiveness of existing anti-vascular endothelial growth factor (VEGF) therapies, there is a constant need for treatments that can improve response rates and reduce injection frequency.
This study conducted with treatment-naive adults and those who had previously received anti-VEGF therapy did reveal intriguing results. Participants were randomized 2:1 to receive either brolucizumab (6 mg) or aflibercept (2 mg) via intravitreal injection every 4 weeks.
At the heart of the trial was the change in best-corrected visual acuity at week 52. Brolucizumab demonstrated noninferiority to aflibercept, showcasing a 12.2-letter improvement compared to aflibercept's 11.0-letter improvement.
Crucially, brolucizumab exhibited superiority in several aspects. The proportion of eyes without subretinal and intraretinal fluid was significantly higher in the brolucizumab group (41.6%) compared to aflibercept (22.2%). Additionally, the mean central subfield thickness change from baseline favored brolucizumab (-237.8 μm) over aflibercept (-196.5 μm).
Importantly, the trial found that brolucizumab's safety profile was comparable to aflibercept, with no new safety concerns identified. Incidences of intraocular inflammation, retinal vasculitis, and retinal vascular occlusion were monitored and were within an acceptable range.
The results of this trial mark a significant stride in DME treatment, suggesting that brolucizumab could offer a viable alternative for patients. While both drugs demonstrated similar visual outcomes, the superior anatomic improvements seen with brolucizumab indicate a potential edge in addressing the complexities of DME.
Source:
Singh, R. P., Barakat, M. R., Ip, M. S., Wykoff, C. C., Eichenbaum, D. A., Joshi, S., Warrow, D., Sheth, V. S., Stefanickova, J., Kim, Y. S., He, F., Cho, G. E., Wang, Y., & Emanuelli, A. (2023). Efficacy and Safety of Brolucizumab for Diabetic Macular Edema. In JAMA Ophthalmology. American Medical Association (AMA). https://doi.org/10.1001/jamaophthalmol.2023.5248