An update of a 52-week clinical trial unveiled promising results of brolucizumab compared to the standard aflibercept in enhancing diabetic macular edema (DME) treatment. The findings were published in Journal of American Medical Association.
DME is a serious complication of diabetes impacting vision, conventionally been treated with anti-vascular endothelial growth factor (VEGF) therapies. The need for improved response rates and less frequent injections has prompted researchers to explore alternative treatments.
The study, conducted from September 2019 to March 2020 and analyzed from April 2020 to February 2021, enrolled both treatment-naive adults and those who had prior anti-VEGF therapy. Participants were randomized to receive either brolucizumab or aflibercept, both administered via intravitreal injection every four weeks.
The primary endpoint was the change in best-corrected visual acuity at week 52, revealing that brolucizumab demonstrated noninferiority to aflibercept, with a significant 12.2-letter improvement compared to 11.0-letter improvement of aflibercept.
Brolucizumab showed superiority in certain aspects like, the proportion of eyes without subretinal and intraretinal fluid significantly favored brolucizumab, marking a 20.0% difference. The mean central subfield thickness change from baseline at week 52 showed brolucizumab outperforming aflibercept. The safety profile of brolucizumab remained robust, with a slightly higher incidence of intraocular inflammation but no new safety concerns identified. Notably, there were no clinically meaningful differences in visual outcomes between the two treatments.
This study signifies a potential breakthrough in the management of DME, offering a new avenue for patients and healthcare providers. While both brolucizumab and aflibercept exhibit efficacy, the superior anatomical improvements seen with brolucizumab This hints a promising future for this innovative treatment. Further research and real-world application are anticipated to validate these findings, shaping the landscape of DME treatment.
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
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