Brolucizumab is safe, effective in diabetic macular edema
A 52-week Phase 3 clinical trial comparing brolucizumab and aflibercept in the treatment of diabetic macular edema (DME) showed that both drugs were effective in improving visual outcomes. Brolucizumab was found to be noninferior to aflibercept in terms of best-corrected visual acuity, and it demonstrated superiority in certain anatomic improvements, including a higher proportion of eyes without subretinal and intraretinal fluid.
The double-masked randomized clinical trial included 517 participants, consisting of treatment-naive adults and those who had previously received anti-VEGF therapy, were randomized 2:1 to intravitreal injections of brolucizumab (6 mg) every 4 weeks or aflibercept (2 mg) with the same dosing schedule.
The primary endpoint was the change from baseline in best-corrected visual acuity at week 52. Results indicated that brolucizumab was noninferior to aflibercept in visual acuity improvement, with a 12.2-letter improvement compared to aflibercept’s 11.0-letter improvement.
Brolucizumab demonstrated superiority over aflibercept in anatomic improvements. The proportion of eyes without subretinal and intraretinal fluid was significantly higher in the brolucizumab group (41.6%) compared to the aflibercept group (22.2%). In addition, the mean central subfield thickness change from baseline at week 52 favored brolucizumab (-237.8 μm) over aflibercept (-196.5 μm).
The incidence of intraocular inflammation was slightly higher in the brolucizumab arm (4.0%) compared to aflibercept (2.9%). Other safety concerns, such as retinal vasculitis and retinal vascular occlusion, showed minimal differences between the treatment groups, with no new safety concerns identified.
Singh RP, Barakat MR, Ip MS, et al. Efficacy and Safety of Brolucizumab for Diabetic Macular Edema: The KINGFISHER Randomized Clinical Trial. JAMA Ophthalmol. Published online November 16, 2023. doi:10.1001/jamaophthalmol.2023.5248