EAST HANOVER, N.J., May 1, 2021 /PRNewswire/ — Novartis today announced positive one-year results of the Phase III KESTREL and KITE* studies, evaluating the efficacy and safety of BEOVU® (brolucizumab-dbll) 6 mg in diabetic macular edema (DME). Both studies met their primary endpoints of non-inferiority in change in best corrected visual acuity (BCVA) from baseline for BEOVU 6 mg versus aflibercept 2 mg at year one1. In KESTREL, patients on BEOVU 6 mg gained a mean of 9.2 letters versus 10.5 letters for patients on aflibercept 2 mg1. In KITE, patients on BEOVU 6 mg gained a mean of 10.6 letters versus 9.4 letters for patients on aflibercept 2 mg1. These results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting.
In pre-specified secondary endpoints, fewer eyes treated with BEOVU had intraretinal and/or subretinal fluid (IRF/SRF) at week 32 (first assessment of disease activity) and week 52 versus eyes treated with aflibercept1. More eyes treated with BEOVU 6 mg than eyes treated with aflibercept achieved central subfield thickness (CSFT) levels below 280 μm at weeks 32 and 521. Fluid is a key marker of disease activity in DME and CSFT is a key indicator of fluid in the retina1.
“Treatment for diabetic macular edema is a high unmet medical need in the US and globally. Our goal as physicians is to work on preventing blindness for the significant proportion of diabetics affected by this condition,” said David M Brown MD FACS, Director of Clinical Research at the Retina Consultants of Texas and principal investigator of the KESTREL clinical trial. “DME patients often struggle with adherence due to the need to manage multiple comorbidities related to diabetes. The KESTREL and KITE clinical trials – the first pivotal trials to examine a longer dosing interval in the loading phase – confirm BEOVU’s potential to be an important therapy for these patients.”
To study its potential in reducing treatment burden, BEOVU was given at six-week dosing intervals during the loading phase versus aflibercept, which was given at the standard four-week dosing intervals, in line with its label1,2. Following the loading phase, over half of