Novartis receives EC Approval for Beovu, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

• Beovu (brolucizumab) is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on three-month dosing intervals immediately after the loading phase¹
   
• For the more than 20 million people worldwide who are living with wet AMD, frequent injections are a common reason patients drop off existing treatments^2-4
   
• Approval is based on two head-to-head clinical trials, HAWK and HARRIER, in which Beovu achieved robust vision gains that were non-inferior to aflibercept at year one (primary endpoint)^1,5
   
• Beovu also demonstrated superior fluid resolution versus aflibercept at week 16 and year one (secondary endpoints)^1,5

The digital press release with multimedia content can be accessed here:

Basel, February 17, 2020 – Novartis today 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)^1,5. Beovu also offers the ability to start eligible wet AMD patients on a three-month dosing interval immediately after the loading phase^1,5. The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

“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,” said Marie-France Tschudin, President Novartis Pharmaceuticals. “With the approval of this innovative biologic, Novartis is continuing to reimagine medicine for people living with wet AMD.” 

“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.”

Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision^6,7. The disease is a leading cause of severe vision loss and blindness in people over age 65, affecting more than 20 million people worldwide^3,4,8. In the EU, an estimated 1.7 million people are affected by wet AMD⁹. Early symptoms of wet AMD include blurry or wavy vision⁷. As the disease progresses, patients lose central vision, making it difficult to see objects directly in front of them⁷.