Novartis Presents Positive Results From Three Phase 3 Trials of Beovu in DME

At the Angiogenesis, Exudation, and Degeneration 2022 Virtual Meeting, Novartis presented additional positive results from three phase 3 trials of Beovu in DME, including results from patients dosed at up to 16-week intervals. This was the first detailed presentation of the year 2 results from the KESTREL and KITE trials, and the 1-year KINGFISHER study. 

Novartis’ DME application for Beovu is currently under review by the FDA and EMA authorities.

KESTREL and KITE

• Novartis presented additional year 2 data from the KESTREL and KITE studies of Beovu in DME patients. The results were consistent with positive findings from year 1. 
• Visual acuity gains achieved with Beovu in year 1 were maintained in year 2 and were comparable to gains achieved with aflibercept, despite fewer injections with Beovu.
• Through the end of year 2, the median number of injections was 11 for Beovu versus 15 for aflibercept in KESTREL, and 10 for Beovu versus 15 for aflibercept in KITE.
• Nearly 70% of Beovu 6 mg patients who successfully completed the first 12-week dosing cycle immediately following the loading phase remained on 12-week dosing (KESTREL) and on either 12- or 16-week (KITE) dosing intervals through the end of the studies. 
• In KITE, roughly 25% of Beovu patients were treated on 16-week dosing intervals through the end of the study.
• At year 2, Beovu continued to show robust improvements in key secondary fluid-related endpoints through sustained reductions in central subfield thickness (CSFT) and numerically fewer patients with intra-retinal fluid (IRF) and/or sub-retinal fluid (SRF). 
• The overall safety profile of Beovu was consistent with its safety profile from year 1.

• The Phase 3 KESTREL and KITE trials were the first pivotal trials to assess an anti-VEGF treatment on 6-week dosing intervals in the loading phase, suggesting Beovu may offer the need for fewer injections at the start of treatment.

• If approved, Beovu has the potential to address unmet needs in the DME patient population, such as the opportunity to address fluid and the burden of frequent treatment schedules. 

KINGFISHER

• In KINGFISHER, a 1-year study comparing Beovu and aflibercept at 4-week dosing intervals for the treatment of DME, Beovu demonstrated noninferior visual gains and superiority in key fluid-related secondary endpoints, with no new safety signals, through the end of the study.

• NOTE: Beovu 6 mg is not currently approved for the treatment of DME. In wet AMD, the recommended dose for Beovu 6 mg is monthly for the first three doses, followed by one dose every eight to 12 weeks.

• KINGFISHER met its primary endpoint of noninferiority to aflibercept in best corrected visual acuity (BCVA) from baseline at year 1 (week 52).

• Beovu demonstrated superiority in key fluid-related secondary endpoints at year 1, including reductions in CSFT and absence of IRF and SRF.

• In KINGFISHER, the time to first absence of IRF and SRF was shorter with Beovu versus aflibercept.

• Beovu demonstrated a favorable risk-benefit profile in KINGFISHER, with no new safety signals identified.