Benzinga | Dec 9, 2021 09:44PM EST

Novartis Announced Results from Year Two of Phase III Trial of Beovu in Diabetic Macular Edema Confirm Year One Findings With Overall Favorable Benefit-risk Pprofile

Novartis today announced the first interpretable results from year two (week 100) of the Phase III KESTREL study. KESTREL assessed the safety and efficacy of Beovu(r) (brolucizumab) 6 mg in patients with visual impairment due to diabetic macular edema (DME). 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 patients1,2.

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)1,2. Additionally, numerically fewer Beovu patients had intraocular fluid and/or sub-retinal fluid (IRF/SRF) versus patients treated with aflibercept1. CSFT is a key indicator of fluid in the retina, and fluid is a key marker of disease activity3,4.

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 aflibercept1.

"With an average age at diagnosis of 48 years, DME primarily affects working-age adults, which means managing their vision, in addition to multiple comorbidities related to diabetes, may result in loss of work productivity and employment instability5,6," said Dr. David M Brown MD, Director of Research, Retina Consultants of Texas. "The extended dosing and fluid resolution observed in year two of the KESTREL clinical trial suggest Beovu has the potential to help appropriate patients more conveniently and effectively manage their disease with dosing intervals every 12 weeks after an initial loading phase."

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.

About the KESTREL year two safety resultsIn 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 aflibercept1. Rates of retinal vascular occlusion (RO) were 1.6% for both Beovu 6 mg and 3 mg versus 0.5% for aflibercept1. The majority of IOI events were manageable and resolved without any clinical complications1. There were no vascular events reported in year two (weeks 52-100)1. No new RV events were reported during year two of KESTREL1. 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 RV1.

Brolucizumab 6 mg is the commercialized dose of Beovu in wet age-related macular degeneration (AMD)7. Novartis is committed to bringing Beovu 6 mg to DME patients and has submitted data from KESTREL and KITE (NCT03481660), to global health authorities in H2 2021.

About the KESTREL and KITE clinical trialsKESTREL and KITE are global, randomized, double-masked, Phase III, two-year studies comparing the safety and efficacy of Beovu and aflibercept in the treatment of patients with visual impairment due to DME8,9.

KESTREL and KITE involved 926 total patients in 36 countries8,9. In the loading phase of both trials, patients in the Beovu arms were treated every six weeks for a total of five doses; patients in the aflibercept arms were treated every four weeks for a total of five doses, in line with its label at the start of the studies8,9. Following the loading phase, patients in the Beovu arms were subsequently treated every 12 weeks, with those demonstrating disease activity moved to dosing every eight weeks for the remainder of the study8,9. At week 72 of KITE, Beovu patients dosed every 12 weeks could be extended to dosing every 16 weeks, and patients dosed every eight weeks could be extended to every 12 weeks9.