Novartis' Beovu meets primary endpoint in late-stage diabetic macular edema study

 

• Novartis (NYSE:NVS) announces positive findings from the Phase III KESTREL study, assessing the safety and efficacy of Beovu (brolucizumab) 3 mg and 6 mg in diabetic macular edema (DME).
• The trial met its primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline of Beovu 6 mg to aflibercept 2 mg at year one.
• Key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 521 was also achieved.
• Significant improvement with Beovu 6 mg in change of central subfield thickness (CST) from baseline over the period of week 40 through week 52 was observed.
• As non-inferiority in change in BCVA of brolucizumab 3 mg was not demonstrated, no confirmatory testing of superiority on anatomical outcomes was performed.
• Beovu demonstrated an overall well-tolerated safety profile.
• In September 2020, Novartis announced positive topline results from Phase III KITE study.
• The company intends to submit the data from KESTREL, together with KITE study in DME, to health authorities in H1 2021.
• https://seekingalpha.com/news/3644287-novartis-beovu-meets-primary-endpoint-in-late-stage-study-in-diabetic-macular-edema