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European Commission approves Beovu to treat wet age-related macular degeneration. Novartis

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Published:18th Feb 2020
Novartis has announced the European Commission (EC) has approved Beovu (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity, versus aflibercept (secondary endpoints). Beovu also offers the ability to start eligible wet AMD patients on a three-month dosing interval immediately after the loading phase.

The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein. “Drying the retina is one of the main goals in the treatment of wet AMD with anti-VEGF therapy,” said Frank Holz, MD, FEBO, FARVO, Professor and Chairman, Department of Ophthalmology, University of Bonn, Germany. “Beovu, with its superior fluid resolution as demonstrated in the HAWK and HARRIER trials, will provide physicians with a new option to treat wet AMD.” The EC approval was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint, demonstrating gains in best corrected visual acuity (BCVA) that were non-inferior to aflibercept at year one (week 48) Vision gains at year one were maintained at year two.

Condition: Age Related Macular Degeneration
Type: drug

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