Novartis announced positive findings from the first interpretable results of the 571-patient phase 3 KESTREL study, assessing the efficacy and safety of Beovu (brolucizumab) 3 mg and 6 mg in diabetic macular edema (DME). The trial met its primary endpoint of noninferiority in change in best-corrected visual acuity (BCVA) from baseline of Beovu 6 mg to aflibercept 2 mg (Eylea; Regeneron) at year 1. The trial also met its key secondary endpoint of noninferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 52. More than half of patients in the Beovu 6 mg arm were maintained on a 3-month dosing interval through year 1, following the loading phase. Patients treated with Beovu 6 mg experienced significant improvement in change of central subfield thickness (CST) from baseline over the period of week 40 through week 52.

“These results demonstrate that Beovu has the potential, if approved, to offer DME patients better disease management,” said Dirk Sauer, global head of development for Novartis Pharma Ophthalmology, in a news release. “Based on these data and the strong results we saw earlier this year from the KITE clinical study, we look forward to working with regulatory authorities to bring Beovu to DME patients.” In KESTREL, Beovu demonstrated an overall well-tolerated safety profile. Novartis announced positive top-line results from the 361-patient KITE pivotal phase 3 DME study in September 2020. Novartis intends to submit the data from both KITE and KESTREL to health authorities in the first half of 2021.