Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy.
European regulators have confirmed that Novo Nordisk’s semaglutide increases the risk of a rare eye condition that can cause vision loss. The conclusion from the European Medicines Agency (EMA) affirms two studies that suggested the link back in December 2024.
The EMA’s safety committee said that non-arteritic anterior ischemic optic neuropathy (NAION) is indeed a rare safety risk of semaglutide, which is marketed as Wegovy for weight loss and Ozempic for diabetes. The committee said the side effect occurs in up to one in 10,000 people who take semaglutide.
Given the evidence, based on non-clinical studies, clinical trials, post-marketing surveillance and medical literature, the committee has recommended that semaglutide’s labels be updated to include the “very rare” risk, according to the Friday announcement.
Breaking down the risk further, the EMA committee explained that the studies it reviewed showed that adults with type 2 diabetes who took the drugs had an approximately twofold increase in the risk of developing NAION, with an estimated two cases of the condition per 10,000 patient years of treatment. A patient year corresponds to one person taking semaglutide for one full year.
“If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay,” the EMA committee said. “If NAION is confirmed, treatment with semaglutide should be stopped.”
In December 2024, the Danish Medicines Agency announced a plan to review the new eye safety risk that had been seen in several patients taking Ozempic. Two studies conducted in the country suggested that patients who receive the GLP-1 medicine have an increased risk of developing NAION. At that point, 19 cases of the condition had been reported.
The EMA followed suit a few days later, launching an investigation into the evidence. With the review completed, the committee will send its recommendation to the Committee for Medicinal Products for Human Use (CHMP), which will forward it on to the European Commission that can then issue a legally binding decision.
