Novartis announces positive results from Phase III trial of Beovu
pharmafile | December 9, 2021 | News story | Business Services |
Novartis have announced the first interpretable results from year two (week 100) of the Phase III KESTREL study. KESTREL assessed the safety and efficacy of Beovu (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 the first year, whilst addressing the burden of frequent treatments for DME patients. These results were consistent with those seen at year one, including maintenance of best-corrected visual acuity (BCVA) and sustained reductions in central subfield thickness (CSFT). There were also fewer Beovu patients who 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.
Over 40% of Beovu patients were maintained on 12-week dosing intervals, and 70% of patients who completed the 12-week cycle after loading remained on 12-week dosing through year two. This demonstrates the potential for Beovu to offer fluid resolution in more DME patients with fewer injections versus aflibercept.
“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 instability,” 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.”