Danish Regulators Flag Eye Risk for Novo’s Ozempic, Requesting EU Review

The Danish Medicines Agency had been watching reports of a rare eye disease in patients who took Novo’s GLP-1 drug but until now have declined to move forward with a more formal review. Two new studies have strengthened the link.

The Danish Medicines Agency plans to request a review of a new eye safety risk that has been flagged in patients taking Novo Nordisk’s Ozempic, the drug regulator announced Monday. Two studies conducted in the country suggest that patients who receive the GLP-1 medicine have an increased risk of developing a rare eye disease called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause sudden vision loss.

The Danish regulator has received reports of 19 cases of NAION so far. The first, received in July, was a suspected adverse reaction to semaglutide, which is the active ingredient of Novo’s GLP-1 medicine, marketed as Wegovy for weight loss and Ozempic for diabetes.

The Danish Medicines Agency had until now been simply monitoring the safety reports because the data link was not strong enough, but the two new studies have strengthened the tie between the rare eye condition and semaglutide. The regulator will now request a review of the studies by the European Pharmacovigilance Risk Assessment Committee of the European Medicines Agency.

One of the studies reviewed data from more than 424,000 patients with diabetes, with a quarter receiving Ozempic. The second study evaluated data from over 44,000 Danish patients who received the drug between 2018 and 2024, plus nearly 17,000 patients in Norway who received it in a similar timeframe.

“In the past six months, we have evaluated reports and studies involving the serious eye condition known as NAION in collaboration with our European colleagues,” said Line Michan, the director of department at the Danish Medicines Agency. “These new register-based studies provide comprehensive data from Danish and Norwegian registers that the European Pharmacovigilance Risk Assessment Committee may now consider. Therefore, we will now request PRAC to assess thew new studies.”

Michan cautioned that the link has not yet been proven and NAION remains a rare condition.

Wegovy and Ozempic are expected to add $28.4 billion to Novo’s total revenue this year, according to a recent analysts by BMO Capital Markets.

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