Novartis announced the first interpretable results from year 2 (week 100) of the PIII KESTREL study. Results were consistent with those seen at year 1, including maintenance of best-corrected visual acuity (BCVA) and sustained reductions in central subfield thickness (CSFT). Additionally, numerically fewer brolucizumab patients had intraocular fluid and/or sub-retinal fluid (IRF/SRF) vs patients treated with aflibercept. More than 40% of brolucizumab 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 2, showing the potential for brolucizumab to offer fluid resolution in more DME patients with fewer injections vs aflibercept. Rates of intraocular inflammation (IOI) were 4.2% for brolucizumab 6 mg, 5.3% for brolucizumab 3 mg and 1.1% for aflibercept; retinal vasculitis (RV) rates were 0.5% for brolucizumab 6 mg, 1.6% for brolucizumab 3 mg and 0% for aflibercept. Rates of retinal vascular occlusion (RO) were 1.6% for both brolucizumab 6 mg and 3 mg vs 0.5% for aflibercept. The majority of IOI events were manageable and resolved without any clinical complications .
KESTREL study of Beovu demonstrated significant improvement in central subfield thickness in Diabetic Macular Edema (DME), re-affirming the positive topline results announced in September from pivotal KITE study.
PIII KESTREL and KITE studies are no longer recruiting. Positive topline results from KITE were reported in Sep 20. The trial met its primary and key secondary endpoints, demonstrating non-inferiority for brolucizumab 6mg vs aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52) [6,7].
PIII KINGFISHER trial (NCT03917472) to evaluate efficacy and safety of brolucizumab versus aflibercept plans to recruit 500 patients from the US, Hungary and Slovakia. Estimated primary completion date July 2021 .
PIII KESTREL and KITE studies are recruiting .
PIII KITE study to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema starts (NCT03481660). 356 adults will be recruited in countries in the EU and elsewhere. Primary outcome is change from baseline in best-corrected visual acuity (BCVA) at Week 52; collection of these data is due to complete Jul 20 .
PIII KESTREL study to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular oedema starts (NCT03481634). 534 adults will be recruited from countries including the US & EU (Plus UK). Primary outcome is change from baseline in best-corrected visual acuity (BCVA) at Week 52; collection of these data is due to complete Sep 20 .