Phase III KESTREL study of Beovu confirms benefits in diabetic macular edema.- Novartis

Results from year two confirmed the visual acuity gains, fluid reduction findings and safety profile from year one, while addressing the burden of frequent treatments for DME patients.

Results from year two of KESTREL were consistent with those seen at year one, including maintenance of best-corrected visual acuity (BCVA) and sustained reductions in central subfield thickness (CSFT). Additionally, numerically fewer Beovu patients had intraocular fluid and/or sub-retinal fluid (IRF/SRF) versus patients treated with aflibercept. CSFT is a key indicator of fluid in the retina, and fluid is a key marker of disease activity. More than 40% of Beovu patients were maintained on 12-week dosing intervals, and 70% of patients who completed the first 12-week cycle after loading remained on 12-week dosing through year two, showing the potential for Beovu to offer fluid resolution in more DME patients with fewer injections versus aflibercept.

In KESTREL (NCT03481634), rates of intraocular inflammation (IOI) were 4.2% for Beovu 6 mg, 5.3% for Beovu 3 mg and 1.1% for aflibercept; retinal vasculitis (RV) rates were 0.5% for Beovu 6 mg, 1.6% for Beovu 3 mg and 0% for aflibercept. Rates of retinal vascular occlusion (RO) were 1.6% for both Beovu 6 mg and 3 mg versus 0.5% for aflibercept. The majority of IOI events were manageable and resolved without any clinical complications. There were no vascular events reported in year two (weeks 52-100). No new RV events were reported during year two of KESTREL. Of the four new RO events reported during year two (two in Beovu 6 mg, one in Beovu 3 mg and one in aflibercept), none were associated with IOI or RV. Further details of year-two findings from the KESTREL trial, along with findings from KITE, another pivotal Phase III trial of Beovu in DME, will be presented at upcoming medical congresses.