European drug regulators are reportedly reviewing research that links Novo Nordisk‘s blockbuster diabetes injection Ozempic to a rare eye disorder.

After the release of two independent studies from the University of Southern Denmark that suggested Type 2 diabetes patients who are treated with Ozempic have an increased risk of developing damage to the optic nerve of the eye, the European Union decided to investigate, according to Reuters.

The move came a day after a Dec. 16 request from the Danish Medicine Agency (DMA) to look closer at the findings.

Known as non-arteritic anterior ischemic optic neuropathy, NAION is characterized by vision loss due to decreased blood flow to the front part of the optic nerve. The disease most often occurs in people ages 50 and up. It can lead to severe and permanent loss of vision.

Within the U.S., NAION affects between 2.3 and 10.2 patients per 100,000 people for the population over 50 years old annually, according to the American Academy of Ophthalmology.

Risk factors for the disease include diabetes, hypertension, sleep apnea, smoking and small optic discs, the National Institutes of Health noted.

What about Wegovy?

In the request to EU regulators, the DMA said it has been monitoring NAION as a possible side effect of semaglutide – the active ingredient in Ozempic – over the past six months.

As of Dec. 10, the agency said it received 19 reports in the country of the condition.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee said other research it has reviewed so far is not strong enough to support a link between Ozempic and the eye disease. However, it will examine the latest findings from the Danish studies, Reuters reported.

Authorized by the U.S. Food and Drug Administration in 2017, Ozempic is a self-injectable treatment. Made using semaglutide for adults with Type 2 diabetes, the drug works by mimicking a natural hormone the body releases when a person eats, potentially causing weight loss as a secondary effect.

The Danish researchers said they need to investigate further whether Wegovy users also have an increased risk of the condition.

Another GLP-1 drug that contains semaglutide, Wegovy received approval in 2021 specifically for chronic weight management in individuals who are obese or overweight with at least one weight-related condition.

Novo Nordisk – which has its U.S. headquarters in Plainsboro – told NJBIZ, “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. After a thorough evaluation of the studies from the University of Southern Denmark and Novo Nordisk’s internal safety assessment, Novo Nordisk is of the opinion that the benefit-risk profile of semaglutide remains unchanged.”

Other concerns

“While both studies showed a roughly doubling of relative risk, the absolute risk and absolute number of people affected is very low. This aligns with the very low annual incidence of this rare disorder. One of the studies found that 2 people per 10,000 patients treated with semaglutide in a year developed NAION versus 1 out of every 10,000 in the comparator group, concluding that the absolute risk is very low. The studies did not demonstrate a causal relationship between semaglutide and NAION,” the company’s statement said.

“Novo Nordisk, on its part, has conducted an analysis across randomized controlled clinical trials with GLP-1 receptor agonists, including a blinded ophthalmologist evaluation to confirm NAION diagnoses,” the statement went on. “Through this analysis, very few cases of ophthalmologist-confirmed NAION cases were identified, with no imbalance disfavoring Novo Nordisk GLP-1 receptor agonists.”

For Novo Nordisk, it’s the latest potential concern about GLP-1 medications. Despite high costs and unpleasant side effects, like nausea and vomiting, demand for the drug class continues to surge.

Novo Nordisk, as well as Eli Lilly, face scores of personal injury claims in a multidistrict litigation in Philadelphia federal court for allegedly failing to warn patients about side effects of their popular diabetes and weight loss drugs. Complications include gastroparesis, intestinal obstruction and other digestive problems.

Since establishing the MDL in February, people have filed over 1,200 complaints saying they endured severe side effects after being prescribed GLP-1 drugs to treat diabetes or aid weight loss.

Patients also accuse the companies of not warning doctors about potential problems associated with Novo Nordisk’s Ozempic, Wegovy and Rybelsus as well as Eli Lilly’s Trulicity and Mounjaro.

In court filings, both companies have said gastrointestinal issues are well known side effects and printed on the product labels.

See also:

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