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Novartis' Beovu injection gets US FDA approval for chronic eye disorder

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Novartis headquarters
Source: Novartis

Novartis AG said the U.S. Food and Drug Administration approved Beovu injection for treating a chronic eye disorder called wet age-related macular degeneration.

Beovu, also known as brolucizumab or RTH258, is now approved by the U.S. regulator to counter excessive vascular endothelial growth factor, or VEGF, which causes wet AMD. VEGF is a signal protein that stimulates the growth of abnormal blood vessels underneath the macula, the area of the eye's retina responsible for sharp vision.

The approval was based on results from late-stage studies, dubbed Hawk and Harrier, which showed that fewer patients who were on Beovu had intraretinal and/or subretinal fluid — a key marker of disease activity — compared to subjects on aflibercept. Beovu also significantly reduced central subfield thickness, a key indicator of abnormal fluid in the retina, the Swiss drugmaker said.

Aflibercept is marketed by Regeneron Pharmaceuticals Inc. as Eylea and is one of the Tarrytown, N.Y.-based drugmaker's top-selling drugs.

"With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas," according to Pravin Dugel, principal investigator of the Hawk clinical trial.

Wet AMD, symptoms of which include blurry or wavy vision, distorts central vision and could eventually lead to blindness. Nearly 1.8 million individuals in the U.S. are estimated to have the eye disease by 2020.