Feb 17, 2020: Novartis announced the European Commission 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 the retinal fluid (IRF/SRF), a key marker of the disease activity, versus aflibercept (secondary endpoints).
“Beovu also offers the ability to start qualified wet AMD patients on a three-month dosing interval immediately after the loading phase. This decision of EC 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.”Wet AMD is a chronic, degenerative eye disease caused by excess VEGF, a protein that encourages the development of enlarged blood vessels below the macula, the region of
the retina responsible for sharp, central vision. The condition is a leading cause of significant
loss of vision and blindness in individuals over 65 years of age, affecting more than 20 million people worldwide. Initial symptoms of wet AMD include blurry or wavy vision. As the disease progresses, patients lose central vision, making it complicated to see objects directly in front of them.
The EC approval was based on the findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint, demonstrating gains in the best-corrected visual acuity (BCVA) that were non-inferior to aflibercept at year one (week 48). Vision gains at year one and was maintained at year two.
In HAWK and HARRIER, over half of the patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER) at year one. The leftover patients in the study were treated on a two-month dosing interval.
Novartis received approval from the U.S. FDA in October 2019 for Beovu for the treatment of wet AMD. Beovu received Swissmedic approval in Switzerland and Australian TGA approval in January 2020 for the treatment of wet AMD. Novartis is committed to bringing Beovu to the patients worldwide, and other regulatory filings are at present underway in Canada, Japan and Brazil.
About Beovu (brolucizumab): Beovu (brolucizumab, also known as RTH258) is the most
scientifically advanced single chain humanized fragment of an antibody (scFv). Due to their small size, improved tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics, singlechain antibody fragments are highly sought after in drug development.
About wet age-related macular degeneration
Wet AMD is the leading cause of severe vision loss and legal blindness in the people above 65 years age in North America, Europe, Australia and Asia, impacting an approximate 20 million people worldwide. Wet AMD occurs when abnormal blood vessels from the bottom of the macula, the area of the retina responsible for the sharp, central vision. These blood vessels are fragile and leak fluid, disrupting the typical retinal architecture and eventually causing damage to the macula”.