Novartis has announced the first interpretable results of Beovu in patients with diabetic macular edema.
Novartis has announced the Phase III KITE study results; Beovu (brolucizumab) 6 mg achieved both the primary and the secondary endpoints. The trial was designed to demonstrate efficacy vs. aflibercept.
Mean change in best-corrected visual acuity (BCVA) was considered as the primary endpoint; Beovu showed non-inferiority vs. aflibercept. Change of central subfield thickness is considered as a secondary endpoint, in which Beovu demonstrated superiority vs. aflibercept.
KITE study is an ongoing two-year Phase 3 study, enrolled 360 patients across 23 countries. The company has announced that it will present the data in medical conferences and submit for peer-review publication. Novartis conducting a second trial in DME patients, KESTREL, results are expected to be published by the end of this year.
Beovu is a humanized single-chain antibody fragment, which is in various stages of development for diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy. It was already approved in more than 40 countries for wet AMD.
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