Novo Nordisk’s Ozempic linked to rare cases of serious eye disorder, EU regulator confirms.

Novo Nordisk’s popular weight-loss and diabetes drugs Wegovy and Ozempic in cases cause a serious eye condition that can lead to vision loss, the European Medicines Agency’s (EMA) safety committee said on Friday.

In the past, studies in type-2 diabetes patients have linked Ozempic to the condition called Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). But this is the first time a regulator has confirmed the side effect.

The condition may affect people taking Semaglutide, the active ingredient in Wegovy and Ozempic as well as in Novo’s other diabetes drug Rybelsus, for at least one year, the regulator said. NAION is the second-most common cause of blindness due to optic nerve damage, after glaucoma.

The EMA, which started its review in December, has asked Novo to add NAION as a side effect of very rare frequency in the product information accompanying drugs that contain Semaglutide. Novo said it would work with the EMA to update the labels, adding clinical trials and after-market studies did suggest a reasonable possibility that the drugs caused the condition.

Novo has recently faced investor concerns that it is losing its first-mover advantage in the highly competitive obesity treatment market, leading the company to oust CEO Lars Fruergaard Jorgensen in May.

Wegovy and Eli Lilly’s Zepbound currently dominate the weight-loss drug market, potentially worth about $150 billion by the next decade. The EMA said several large studies in type-2 diabetes patients have suggested that use of Novo’s drugs could raise the risk of developing NAION by twofold.

A study of nearly 350,000 diabetes patients published in March showed that the risk of developing NAION more than doubled after two years of treatment with Ozempic, compared to patients taking medicines from other classes.

Team Maverick.