Phase III Beovu data in KESTREL and KITE studies show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept.- Novartis.

Novartis announced positive one-year results of the Phase III KESTREL and KITE studies, evaluating the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema (DME) . Both studies met their primary endpoints of non-inferiority in change in best corrected visual acuity (BCVA) from baseline for Beovu 6 mg versus aflibercept 2 mg at year one. In KESTREL, patients on Beovu 6 mg gained a mean of 9.2 letters versus 10.5 letters for patients on aflibercept 2 mg. In KITE, patients on Beovu 6 mg gained a mean of 10.6 letters versus 9.4 letters for patients on aflibercept 2 mg. These results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. In pre-specified secondary endpoints, fewer eyes treated with Beovu had intraretinal and/or subretinal fluid (IRF/SRF) at week 32 (first assessment of disease activity) and week 52 versus eyes treated with aflibercept. More eyes treated with Beovu 6 mg than eyes treated with aflibercept achieved central subfield thickness (CSFT) levels below 280 ?m at weeks 32 and 52. Fluid is a key marker of disease activity in DME and CSFT is a key indicator of fluid in the retina . To study its potential in reducing treatment burden, Beovu was given at six-week dosing intervals during the loading phase versus aflibercept, which was given at the standard four-week dosing intervals, in line with its label. Following the loading phase, over half of patients in the Beovu 6 mg arm (55.1% in KESTREL and 50.3% in KITE) remained on a three-month dosing interval through year one, based on a treatment approach determined by disease activity assessment. If disease activity was detected, Beovu 6 mg patients were switched to two-month intervals through the end of the trial. All aflibercept patients were on a two-month interval after the loading phase.. The Phase III KESTREL and KITE studies enrolled a total of 926 patients in 36 countries. Beovu 6 mg is the commercialized dose in wet age-related macular degeneration (AMD). The brolucizumab 3 mg arm, which was only included in KESTREL, did not meet the primary endpoint. Beovu was overall well-tolerated in KESTREL and KITE. The most common ocular and non-ocular adverse events ( greater than 5%) in KESTREL and KITE were conjunctival hemorrhage, nasopharyngitis and hypertension. IOI rates in KESTREL were 4.7% for brolucizumab 3 mg (including 1.6% retinal vasculitis), 3.7% for Beovu 6 mg (including 0.5% retinal vasculitis), and 0.5% for aflibercept 2 mg1. IOI rates in KITE were equivalent (1.7%) between the Beovu 6 mg and aflibercept 2 mg arms with no retinal vasculitis reported. Retinal vascular occlusion was reported in KESTREL for brolucizumab 3 mg (1.1%) and 6 mg (0.5%), and in KITE for brolucizumab and aflibercept (0.6% each). The majority of these events were manageable and resolved with or without treatment. Novartis is committed to bringing Beovu 6 mg to market for DME patients, subject to regulatory approvals, and will be submitting these one-year data from the KESTREL and KITE trials to global health authorities in H1 2021. Novartis anticipates two-year results from KESTREL and KITE later in 2021. Beovu (brolucizumab, also known as RTH 258) is approved for the treatment of wet age-related macular degeneration (AMD) in more than 60 countries, including in the US, EU, UK, Japan, Canada and Australia. Additional trials, which study the effects of brolucizumab in patients with wet AMD, DME, retinal vein occlusion (RVO) and proliferative diabetic retinopathy (PDR), are currently ongoing. See-.Brown D, Wolf S, Garweg JG, et al. "Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KESTREL & KITE studies". Presented at: The Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. May 2021.