Long-term data confirm efficacy, durability of brolucizumab in diabetic macular edema

Brolucizumab helps improve visual and anatomic outcomes in diabetic macular edema (DME), with long-term efficacy and durability and no new safety signals, as shown in the 100-week data from the phase III KESTREL and KITE studies.

The analysis included 926 patients with DME who received either brolucizumab 3 mg/6 mg (BRO3/BRO6) or aflibercept 2 mg (AFL) in KESTREL (n=566) or either BRO6 or AFL in KITE (N=360).

Patients in the BRO3/BRO6 arms in KESTREL received five loading doses every 6 weeks followed by every-12-weeks dosing, with an option to adjust to every-8-weeks dosing at predefined disease activity assessment visits. Meanwhile, treatment intervals for patients in the BRO6 arm in KITE could be extended by 4 weeks based on the disease stability assessment at week 72. Patients in the AFL arms in both studies received five monthly loading doses, followed by fixed every-8-weeks dosing.

At week 100, best-corrected visual acuity (BCVA) increased from baseline by 8.8 letters with BRO6 and by 10.6 letters with AFL in KESTREL, and by 10.9 with BRO6 and by 8.4 with AFL in KITE. In both studies, fewer BRO6-treated than AFL-treated patients had intraretinal fluid and/or subretinal fluid. These improvements were achieved, with 32.9 percent (KESTREL) and 47.5 percent (KITE) of patients in the BRO6 arms maintained on every-12-weeks and every-12-weeks/every-16-weeks dosing, respectively.

Intraocular inflammation rates with BRO6 vs AFL were 4.2 percent vs 1.1 percent in KESTREL and 2.2 percent vs 1.7 percent in KITE, respectively. The corresponding retinal vasculitis rates were 0.5 percent vs 0 percent in KESTREL, while none occurred in KITE. The retinal vascular occlusion rates were 1.6 percent vs 0.5 percent in KESTREL and 0.6 percent in both treatment arms in KITE, respectively.