Novartis has announced positive results from two Phase III clinical trials assessing Beovu® (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). Year two of the pivotal KITE trial evaluated Beovu on up to 16-week dosing intervals, and the one-year KINGFISHER study evaluated Beovu dosed every four weeks. Both trials demonstrated an overall well-tolerated safety profile.
Results from year two (week 100) of KITE demonstrated that a majority of patients who successfully completed an initial 12-week cycle following the loading phase were maintained on a 12- or 16-week dosing interval through the end of the study. As previously reported, KITE met its primary endpoint of non-inferiority to aflibercept in best-corrected visual acuity (BCVA) from baseline at year one (week 52). At year one, Beovu showed greater reductions versus aflibercept in central subfield thickness (CSFT) and in number of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF), which were key fluid-related secondary endpoints. Year two results were consistent with those seen at year one, including maintenance of BCVA and greater reductions in CSFT and in number of eyes with IRF/SRF treated with Beovu versus aflibercept. CSFT is a key indicator of fluid in the retina, and fluid is a key marker of disease activity4,5. Year two findings from KESTREL, another pivotal Phase III trial of Beovu in DME, are due to read out in Q4 of this year.
“Patients with DME often struggle to adhere to burdensome treatment schedules as they manage various comorbidities related to diabetes,” said Prof. Dr. Justus Garweg, Clinic Director, Berne Eye Clinic at Lindenhof Hospital, Switzerland. “The extended dosing and fluid resolution observed in the KITE clinical trial suggest Beovu has the potential to manage the disease in appropriate patients with a relaxed loading phase every six weeks, and dosing intervals as infrequent as every twelve or sixteen weeks.”
Another Phase III trial, KINGFISHER, met its primary endpoint of non-inferiority to aflibercept in change in BCVA from baseline at year one (week 52) when dosed every four weeks. Beovu also demonstrated superiority versus aflibercept in key fluid-related secondary endpoints at year one, including reductions in CSFT and in number of eyes with IRF/SRF.
Read the full press release from Novartis.