Novo Nordisk (NVO) said Wednesday that two new Danish studies didn't show a causal relationship between Ozempic and a rare eye disease called nonarteritic anterior ischemic optic neuropathy or Naion.
"Naion is a very rare eye disease, and it is not an adverse drug reaction for the marketed formulations of semaglutide (Ozempic, Rybelsus and Wegovy) as per the approved labels," Novo Nordisk said in response to MT Newswires' request for comment on reports that the European Medicines Agency would evaluate the information in the studies.
Novo Nordisk said its opinion on semaglutide's benefit-risk profile remains the same after an evaluation of the studies from the University of Southern Denmark and the company's internal safety assessment.
"While both studies showed a roughly doubling of relative risk, the absolute risk and absolute number of people affected is very low," the company said. "This aligns with the very low annual incidence of this rare disorder."
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