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Roche Holding AG said Monday that its vision-loss treatment Vabysmo has been approved in the European Union after successful phase-3 study data.
Vabysmo (faricimab) is a treatment for age-related macular degeneration and visual impairment due to diabetic macular edema, two conditions linked to vision loss, the Swiss pharmaceutical company
ROG,
said.
The approval from the European Commission–the EU’s executive arm–comes after four phase-3 studies showing vision gains and anatomical improvements in patients given the drug, Roche said.
The treatment will now be available in the bloc, adding to approvals in the U.S., the U.K. and Japan, Roche said. Submissions to other regulatory bodies continue, the company said.
Write to Joshua Kirby at joshua.kirby@wsj.com; @joshualeokirby
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