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The European Medicines Agency’s (EMA) safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns over a potentially increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause loss of vision. Semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used in the treatment of diabetes and obesity (namely Ozempic, Rybelsus and Wegovy).
After reviewing all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials, post-marketing surveillance and medical literature, PRAC has concluded that NAION is a very rare side-effect of semaglutide (it may affect 1 in 10,000 people).
Results from several large epidemiological studies suggest that exposure to semaglutide in adults with type 2 diabetes is associated with a nearly two-fold increase in the risk of developing NAION, compared with people not taking the medicine. This corresponds to approximately one additional case of NAION per 10,000 person-years of treatment (one person-year corresponds to one person taking semaglutide for one year). Data from clinical trials also point to a slightly higher risk of developing the condition in people taking semaglutide, compared with people taking a placebo.
The EMA has, therefore, recommended updating the product information for semaglutide medicines to include NAION as a side effect with a frequency of ‘very rare’. If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay. If NAION is confirmed, treatment with semaglutide should be stopped.
Semaglutide acts similar to GLP-1 (a natural hormone in the body) by increasing the amount of insulin that the pancreas releases in response to food. This helps control blood glucose levels. Semaglutide also regulates appetite by increasing a person’s feelings of fullness, while reducing their food intake, hunger and cravings.
(Source: EMA)
Published on June 15, 2025
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