Novartis Reveals Two Year Results From Beovu Trial In Diabetic Macular Edema Patients

Novartis AG NVS has reported the first interpretable results from year two (week 100) of the Phase 3 KESTREL study of Beovu (brolucizumab) 6 mg in patients with visual impairment due to diabetic macular edema (DME). 

• Results from year two of KESTREL were consistent with those seen at year one, including maintenance of best-corrected visual acuity and sustained reductions in central subfield thickness. 
• Additionally, numerically fewer Beovu patients had intraocular fluid and/or sub-retinal fluid versus patients treated with Regeneron Pharmaceuticals Inc's REGN Eylea (aflibercept). 
• 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.
• Further details of year-two findings from the KESTREL trial and findings from another pivotal Phase 3 (KITE) trial of Beovu in DME will be presented at upcoming medical congresses.
• No vascular events were reported in year two (weeks 52-100). No new retinal vasculitis (RV) events were reported during year two of KESTREL. 
• Price Action: NVS shares are down 1.02% at $80.53 during the market session on the last check Thursday.