The European Commission has granted approval to Beovu for the treatment of visual impairment caused by diabetic macular edema, according to a press release from Novartis.
The approval was based on data from the phase 3 KESTREL and KITE studies in which Beovu (brolucizumab) met the primary endpoint of noninferiority in change in best corrected visual acuity from baseline vs. aflibercept at 1 year.
“KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on 6-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment