Positive Phase III results for Novartis' Beovu IN DME

Swiss pharma giant Novartis (NOVN: VX) has released positive one-year results of the Phase III KESTREL and KITE studies, evaluating the efficacy and safety of Beovu (brolucizumab) 6mg 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 6mg versus aflibercept 2mg at year one.

In KESTREL, patients on Beovu 6mg gained a mean of 9.2 letters versus 10.5 letters for patients on aflibercept 2mg. In KITE, patients on Beovu 6mg gained a mean of 10.6 letters versus 9.4 letters for patients on aflibercept 2mg.

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 aflibercept. More eyes treated with Beovu 6mg than eyes treated with aflibercept achieved central subfield thickness (CSFT) levels below 280 μm at weeks 32 and 52. Fluid is a key marker of disease activity in DME and CSFT is a key indicator of fluid in the retina.