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 the 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.
Beovu (brolucizumab, also known as RTH258) is a humanized single-chain antibody fragment (scFv) approved in more than 40 countries for the treatment of wet AMD. Additional trials are currently ongoing which study the effects of brolucizumab in patients with AMD, diabetic macular edema, retinal vein occlusion and proliferative diabetic retinopathy.
Full news release: https://www.novartis.com/news/media-releases/novartis-reports-positive-topline-results-from-first-phase-iii-trial-beovu-versus-aflibercept-patients-diabetic-macular-edema-dme