Novartis reports positive topline results from second Phase III trial of Beovu in patients with diabetic macular edema

Novartis announced positive findings from the first interpretable results of the Phase III KESTREL study, assessing the efficacy and safety of Beovu (brolucizumab) 3 mg and 6 mg in diabetic macular edema (DME). Following KITE, KESTREL is the second pivotal Phase III study of Beovu in 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. The trial also met its key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 52. (Beovu 6 mg is the marketed dose for wet AMD.)

More than half of patients in the Beovu 6 mg arm were maintained on a three-month dosing interval through year one, 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. As non-inferiority in change in BCVA of brolucizumab 3 mg was not demonstrated in KESTREL, no confirmatory testing of superiority on anatomical outcomes was performed. Further analyses on anatomical outcomes from KESTREL are ongoing.

“These results demonstrate that Beovu has the potential, if approved, to offer DME patients better disease management,” said Dirk Sauer, Global Head Development, Novartis Pharma Ophthalmology. “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 topline results from another pivotal phase III study, KITE, in September 2020. The results from KESTREL support the positive results seen in KITE, reinforcing Beovu as a potential new treatment option for DME patients.

The data from KITE and KESTREL will be submitted to upcoming medical meetings and for peer-review publication. Novartis intends to submit the data from both KITE and KESTREL to health authorities in H1 2021 and looks forward to working with regulators worldwide to make Beovu available to DME patients in need.