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Novartis : Phase III Beovu Data Show Potential For Fluid Resolution In More DME Patients

Novartis AG (NVS) said that phase III Beovu data showed potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept.

The Phase III KESTREL and KITE one-year studies, which evaluated the efficacy and safety of Beovu or brolucizumab 6 mg in diabetic macular edema (DME), 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 one.

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 mg.

The company noted that more patients treated with Beovu 6 mg experienced fluid (IRF/SRF) resolution at week 32 and week 52 versus aflibercept. The fluid is a key marker of disease activity in DME.

Novartis commits to bring Beovu 6 mg to market for DME patients, subject to regulatory approvals, and will submit the one-year data from the KESTREL and KITE trials to global health authorities in the first-half of 2021. The company anticipates two-year results from KESTREL and KITE later in 2021.

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