Novartis reports positive topline results from the first phase III trial of Beovu versus aflibercept in patients with diabetic macular edema (DME).

Novartis reported the first interpretable results of the Phase III KITE study , assessing the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema (DME). The trial met its primary and key secondary endpoints, demonstrating non-inferiority for Beovu versus aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52). In a secondary endpoint, Beovu demonstrated superior improvement versus aflibercept in change of central subfield thickness (CST, a key indicator of fluid in the retina) over the period of week 40 through week 52. More than half of patients in the Beovu arm were maintained on a three-month dosing interval through year one, following the loading phase. All aflibercept patients were on a two-month dosing interval after the loading phase. In KITE, Beovu demonstrated an overall well-tolerated safety profile comparable to aflibercept. In addition, the rate of intraocular inflammation was equivalent between Beovu and aflibercept. The KITE pivotal trial is an ongoing two-year study that enrolled 360 patients with DME across 80 centers in 23 countries. The data from KITE will be submitted for presentation at medical congresses and for peer-review publication. Novartis is currently conducting a second study in DME, KESTREL, and anticipates results later in the year, when Novartis will assess next steps with health authorities .. Novartis is actively progressing studies across wet age-related macular degeneration (AMD), DME, retinal vein occlusion and proliferative diabetic retinopathy. The favorable benefit-risk of the Beovu development program was supported by a company-requested review of ongoing studies by the FDA..