Novartis Files Application for Macular Degeneration Treatment
By Patrick Thomas
Novartis International AG (NVS) said Monday that the U.S. Food and Drug Administration accepted its biologics license application for brolucizumab, an experimental treatment for wet age-related macular degeneration.
Novartis said the FDA is evaluating the treatment in a priority review, and if approved, brolucizumab could hit the U.S. market by year's end.
Novartis said its application was based on clinical data from late-stage efficacy and safety trials of intravitreal injections of brolucizumab.
The company said the tests showed significantly fewer patients treated with brolucizumab had disease activity and retinal fluid compared with patients treated with Regeneron Pharmaceuticals aflibercept, also known as Eylea.
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