A safety committee will review all evidence from trials and studies to shed more light on the potential risk of NAION.
The European Medicines Agency (EMA) says its safety committee has begun a review into reports of an association between use of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and a rare eye condition.
In the last year, several published studies have suggested that semaglutide users have a higher risk for developing nonarteritic anterior ischemic optic neuropathy (NAION). In a paper published last month ahead of print in the International Journal of Retina and Vitreous, researchers from Denmark found that among a large group of patients with type 2 diabetes, once-weekly semaglutide was independently associated with more than double the risk of NAION over 5 years of follow-up. Others have reported more than a fourfold increase in risk. But the data are not clear-cut, with some, including a multinational real-world study using deidentified medical records, not seeing any association.
The EMA says its Pharmacovigilance Risk Assessment Committee (PRAC), which met last week, will now review all available data on NAION and semaglutide from clinical trials and postmarketing surveillance, as well as mechanistic and observational studies.
Patients with type 2 diabetes are thought to be at higher risk for NAION, a condition caused by a reduction in blood flow to the optic nerve. Other systemic cardiovascular risk factors including hypertension and dyslipidemia are also thought to contribute to risk. There is no current treatment for NAION, which over time can result in nerve damage and vision loss.