LONDON

According to the European Medicines Agency’s safety committee, Novo Nordisk’s well-known weight-loss and diabetes treatments, Wegovy and Ozempic, could, albeit very rarely, lead to a serious eye issue that might result in vision loss.

Previously, research conducted on Type 2 diabetes patients had linked Ozempic to a condition known as non-arteritic anterior ischemic optic neuropathy. However, this is the first instance in which a regulatory body has officially recognized this side effect.

The agency indicated that this eye condition could arise in roughly 1 in 10,000 individuals using semaglutide—the active component in Wegovy, Ozempic, and Novo’s other diabetes medication, Rybelsus—over a period of at least a year.

This eye issue is the second-most frequent cause of blindness caused by optic nerve damage, following glaucoma.

Barclays analyst Emily Field noted, “This has been reported as a potential risk for some time, so I think the clinical community is relatively aware of it. I don’t see this as making any major difference to prescribing patterns.”

In early trading, shares of the Danish pharmaceutical company saw an increase of nearly 2.5%.

The safety agency, which initiated its review in December, has requested that Novo include this eye issue as a very rare side effect in the product information for medications containing semaglutide.

Novo announced that it would collaborate with the safety agency to modify the labels, emphasizing that clinical trials and post-market studies did not indicate a reasonable connection between the drugs and this condition.

A company statement declared, “The benefit-risk profile of semaglutide remains favorable.”

Recently, investors have expressed concerns that Novo might be losing its advantage in the competitive obesity treatment market, which led to the dismissal of CEO Lars Fruergaard Jorgensen in May.

Currently, Wegovy and Eli Lilly’s Zepbound lead the weight-loss drug sector, which could be valued at around $150 billion within the next decade.

The European Medicines Agency’s safety committee highlighted that several large studies involving Type 2 diabetes patients suggested that using Novo’s drugs could double the risk of developing this eye problem.

A study from March, analyzing around 350,000 diabetes patients, revealed that the risk of encountering the eye condition more than doubled after two years of Ozempic treatment compared to patients on other types of medications.

The U.S. Department of Health and Human Services has yet to respond to a request for comment regarding whether the Food and Drug Administration is investigating this side effect.