- Results from year two of the pivotal Phase III KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one1,2
- In key fluid-related secondary endpoints from KITE at year two, Beovu (brolucizumab) 6 mg demonstrated greater reductions in central subfield thickness, and fewer patients had intraretinal and/or subretinal fluid versus aflibercept1
- 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 year two of the KITE study
- In KITE, IOI rates were 2.2% for Beovu vs. 1.7% for aflibercept, no retinal vasculitis reported in either arm; equivalent rates of retinal vascular occlusion for both treatments (0.6%)
- Additionally, KINGFISHER, a one-year Phase III study, demonstrated that Beovu was non-inferior to aflibercept in mean change from baseline in best-corrected visual acuity when dosed every four weeks with an overall well-tolerated safety profile3
- Novartis has submitted its applications for Beovu in the treatment of DME to both the FDA and the EMA, supported by findings from KESTREL and KITE pivotal trials, and plans to submit applications in other markets in due course
Basel, August 17, 2021 - Novartis today 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 weeks1,3. 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 study1. 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 aflibercept1,2. 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 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 weeks3. 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/SRF3.
In KITE, the most common (