ZURICH (Reuters) – Swiss drugmaker Novartis said the safety data available for its eye drug Beovu to treat wet age-related macular degeneration (wet AMD) continued to support a favorable benefit-risk profile, but its review of the drug was ongoing.
It said in a statement on Monday it believed the limited number of reported cases of severe vision loss, inflammation and potential retinal vasculitis in patients treated with Beovu were consistent with or below the U.S. package insert that states a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion.
Novartis said last week it had launched an external review into the safety of Beovu after the American Society of Retinal Specialists (ASRS) raised concerns.
(Reporting by Silke Koltrowitz; Editing by Michael Shields)
