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Novo Nordisk's Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say

Novo Nordisk's Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say

Yahoo06-06-2025
The European Medicines Agency's (EMA) safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause vision loss.
Novo Nordisk A/S's (NYSE:NVO) semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used for diabetes and obesity (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 the medical literature, the committee on Friday concluded that NAION is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide).Results from several large epidemiological studies suggest that exposure to semaglutide in adults with type 2 diabetes is associated with an approximately 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 (a dummy treatment).
Therefore, EMA has recommended that the product information for semaglutide medicines be updated to include NAION as a side effect with a frequency of 'very rare.'
In December, a study conducted in Denmark and Norway revealed a potential link between the use of semaglutide for type 2 diabetes and an increased risk of non-arteritic anterior ischemic optic neuropathy (NAION).
Additionally, New research suggests that GLP-1 receptor agonists, widely prescribed for diabetes and weight loss, may significantly raise the risk of age-related macular degeneration in older diabetic patients.
A study published on Thursday in JAMA Ophthalmology by the University of Toronto researchers warns of a potential downside: increased risk of neovascular age-related macular degeneration (nAMD) in diabetic users.
nAMD is a severe form of age-related macular degeneration characterized by the growth of abnormal blood vessels in the back of the eye.
Analyzing medical data from over 1 million Ontario residents with diabetes, researchers identified 46,334 patients prescribed GLP-1 RAs, most of whom were taking semaglutide—likely Ozempic, since Wegovy was only recently approved in Canada.
Patients on these medications were matched with participants not on GLP-1 RAs, sharing similar demographics and health profiles, and tracked for three years.
The study found that diabetic patients taking GLP-1 RAs for at least six months had double the risk of developing neovascular AMD compared to non-users.
Over a mean follow-up period of 2.4 years, 0.2% of the GLP-1 RA cohort progressed to nAMD compared with only 0.1% of control participants, resulting in an increased hazard for nAMD of 2.21 for the GLP-1 RA cohort.
The risk was also highest in those with the longest duration of exposure.
The Guardian report added that those on the medications for more than 30 months had over three times the risk. The risk was even greater in older patients and those with a prior stroke.
Recent findings from the 2025 American Clinical Society of Oncology annual conference suggested that patients using weight loss drugs, including Ozempic, were about 33% more likely to be diagnosed with kidney cancer compared to matched individuals not using the medication.
Price Action: NVO stock is up 2.45% at $74.43 at the last check Friday.
Read Next:Photo by Tobias Arhelger via Shutterstock
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This article Novo Nordisk's Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say originally appeared on Benzinga.com
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