The European Commission has approved Beovu for the treatment of wet age-related macular degeneration, Novartis announced in a press release.
Beovu (brolucizumab) is the first anti-VEGF treatment approved by the EC to demonstrate superior resolution of retinal fluid vs. aflibercept, and it maintains wet AMD patients on a 3-month dosing interval after the loading phase, the release said.
“Currently, wet AMD patients, who are often older, can face significant challenges in managing their disease. We believe that Beovu, and its ability to resolve fluid, brings great therapeutic value that will help physicians optimize treatments for patients based on disease activity,” Marie-France Tschudin, president of Novartis Pharmaceuticals, said in the release. “With the approval of this innovative biologic, Novartis is continuing to reimagine medicine for people living with wet AMD.”
The approval is based on the phase 3 HAWK and HARRIER clinical trials, in which Beovu demonstrated gains in best corrected visual acuity that were noninferior to aflibercept at week 48.