European Commission approves Beovu for DME
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 through year 1,” Jill Hopkins, senior vice president and global development unit head, ophthalmology, Novartis Pharmaceuticals, said in the release. “The EC approval of Beovu in DME may thus help address unmet needs.”
Beovu was previously approved by the European Commission for the treatment of wet age-related macular degeneration in 2020. It is under review by the FDA and the Japanese Pharmaceuticals and Medical Devices Agency for the treatment of DME.
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