ZURICH (Reuters) – Swiss drugmaker Novartis said on Monday the safety data available for its eye drug Beovu to treat wet age-related macular degeneration (wet AMD) continued to support its use as it conducts a review into the safety of the drug.
Novartis’ shares lost about 15% last week after the American Society of Retinal Specialists (ASRS) communicated to its members 14 reports of vasculitis, an inflammation of the blood vessels, of which 11 were designated occlusive retinal vasculitis – a sight-threatening inflammatory eye condition.
The company had launched a review into its injections to treat wet AMD, a condition which can eventually lead to blindness and affects around 20 million people worldwide.
Novartis said on Monday the cases of severe vision loss, inflammation and potential retinal vasculitis were consistent with, or below, the U.S. label of the drug.
While the review was ongoing, reports suggest that most cases of side effects present themselves after the first or second injection of Beovu, the drugmaker said.
Novartis said doctors should advise patients to seek care from an eye specialist if their eyes become red, sensitive to light, or develop a change in vision following the injection.
(Reporting by Silke Koltrowitz in Zurich and Manas Mishra in Bengaluru; Editing by Michael Shields and Amy Caren Daniel)