Following an appeal by the Danish Medicines Agency, the European Union’s drug regulator will review two new studies that have strengthened the link between Novo Nordisk’s blockbuster GLP-1 and a rare eye disease.
The European Medicines Agency said late on Tuesday that it would consider the evidence presented in two recently published studies that Novo Nordisk’s Ozempic could be linked to a rare eye disease, Reuters reported.
The EMA further said that to this point, evidence has not supported a connection between the GLP-1 and NAION (non-arteritic anterior ischemic optic neuropathy) but that the two new studies could yield new clues to the drug’s safety.
Original story published Dec. 16:
Danish Regulators Flag Eye Risk for Novo’s Ozempic, Requesting EU Review
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.
