Investing.com — The European Medicines Agency (EMA), the drug regulator for the European Union, announced on Wednesday that it will review a potential connection between Novo Nordisk (NYSE:NVO)'s popular diabetes drug, Ozempic, and a rare eye condition that can lead to vision loss. This move comes in response to recent scientific studies that have raised concerns about this possible link.
The eye condition in question is nonarteritic anterior ischemic optic neuropathy (NAION), which results from a loss of blood flow to the optic nerve. The EMA will evaluate the data from these studies to determine if the key ingredient in Ozempic could be linked to NAION.
Novo Nordisk, Europe's most valuable company, has seen a surge in sales thanks to the success of Ozempic and its sister weight-loss drug, Wegovy. However, potential side effects of these drugs have recently come under scrutiny.
The EMA's review was prompted by two studies from the University of Southern Denmark which suggested that patients taking Ozempic faced a higher risk of developing NAION. Novo Nordisk responded by emphasizing its commitment to taking all reports of adverse events from its medicines seriously. The company stated that the studies did not establish a causal relationship between semaglutide—the active ingredient in both Ozempic and Wegovy—and NAION.
Novo Nordisk also noted that its internal safety assessment and evaluation of the research studies concluded that the benefit-risk profile of semaglutide remains unchanged.
The EMA's safety committee is currently assessing whether patients treated with semaglutide might have an increased risk of developing NAION. The regulator noted that the evidence available before these latest studies was not strong enough to prove a possible link.
The University of Southern Denmark's studies indicated an increased risk of optic nerve damage for type 2 diabetes patients who took Ozempic. However, they did not establish a direct link between the drug and the disease, and noted that the absolute risk among patients on Ozempic remained low.
These findings were consistent with those of a smaller study by Harvard researchers, which was the first to suggest a risk of developing NAION associated with semaglutide, but did not prove causality.
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