Brolucizumab noninferior to aflibercept for diabetic macular edema

In the treatment of individuals with diabetic macular edema (DME), brolucizumab yields similar visual outcomes as aflibercept, according to data from the phase III KINGFISHER trial.

KINGFISHER included 517 adults with DME (mean age 60.7 years, 57.8 percent male) who were naïve to treatment or had previously received anti-VEGF therapy. These participants were randomly assigned to receive intravitreal injections of brolucizumab 6 mg (n=346) or aflibercept 2 mg (n=171) every 4 weeks for 52 weeks.

The primary endpoint was best-corrected visual acuity at week 52. Secondary endpoints included the proportion of participants with a 2-step improvement or greater from baseline in Diabetic Retinopathy Severity Scale score, the proportion of eyes with absence of both subretinal fluid and intraretinal fluid, change from baseline in central subfield thickness, and safety at week 52.

Compared with aflibercept, brolucizumab had noninferior efficacy in terms of best-corrected visual acuity (Early Treatment Diabetic Retinopathy Study letter score) change from baseline at week 52 (12.2- vs 11.0-letter improvement; difference, 1.1, 95 percent confidence interval [CI], −0.6 to 2.9; noninferiority margin, 4; p<0.001).

On the other hand, brolucizumab showed superiority in terms of the proportion of eyes without subretinal and intraretinal fluid (41.6 percent vs 22.2 percent; difference, 20.0 percent, 95 percent CI, 12.5–28.6; p<0.001) and mean central subfield thickness change from baseline at week 52 (−237.8 vs −196.5 μm; difference, −41.4, 95 percent CI, −58.9 to −23.8; p<0.001).

Intraocular inflammation occurred in 4.0 percent of participants in the brolucizumab arm and in 2.9 percent in the aflibercept arm. The respective rates of retinal vasculitis were 0.9 percent and 0.6 percent, whereas those of retinal vascular occlusion were 0.3 percent and 0.6 percent. Retinal artery occlusion occurred in one participant in the brolucizumab.