FDA Approves Novartis Anti-blindness Drug


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Novartis’s (NYSE: NVS) anti-blindness medicine Beovu has won U.S. Food and Drug Administration approval. The drug is used to treat wet age-related macular degeneration (AMD). Beovu’s list price is around $11,100 for the first year and $7,400 annually thereafter, in line with competing drugs.

Wet AMD is a chronic eye disorder in which patients experience blurred vision or a blind spot. Over time, this can lead to blindness. The condition is estimated to affect about 20 million people worldwide.

Beovu, also known as RTH258 or brolucizumab, is injected into the eye by an eye doctor. Patients first receive a loading dose, then return for boosting shots every few months. Just over half of patients in Novartis’s studies maintained quarterly dosing at the one-year mark with Beovu, with the rest going to dosing every two months.

Beovu joins predecessors Lucentis, which Novartis sells with Roche, and Eylea from both Bayer and Regeneron, in the AMD market. Roche sells Lucentis in the United States, Novartis sells it elsewhere in the world. Novartis sees Beovu as a $1 billion-plus annual seller because Lucentis and Eylea brought in roughly $3.7 billion and $6.4 billion respectively from global sales in 2018.

Beovu’s once-quarterly injection schedule for some patients is less demanding than the once-per-month injections common with Lucentis. Eylea is also approved for quarterly dosing after the first year, but based on instructions to doctors on how to use it, that is not as effective as once every two months. However, some are saying that issues with intraocular inflammation could slow Beovu sales. Intraocular inflammation is a major concern for retinal specialists and a key factor in the treatment selection.