Meeting highlights from the PRAC 13-16 January 2025.

Medicines containing semaglutide: PRAC investigating risk of rare eye condition
PRAC will assess risk of non-arteritic anterior ischemic optic neuropathy (NAION)

EMA’s safety committee, the PRAC, has started a review of medicines containing semaglutide following concerns regarding an increased risk of developing NAION, a rare eye condition, as suggested in two recent observational studies, while two other recent observational studies do not suggest an increased risk.

Semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used in the treatment of diabetes and obesity (namely Ozempic, Rybelsus and Wegovy).

The PRAC is assessing whether patients treated with semaglutide may have an elevated risk of developing NAION. This is a disorder caused by reduced blood flow to the optic nerve in the eye with potential damage to the nerve, which can lead to loss of vision in the affected eye. Patients with type 2 diabetes might already have an inherently higher risk of developing this condition.

The PRAC will now review all available data on NAION with semaglutide including data from clinical trials, post-marketing surveillance, studies on the mechanism of action and the medical literature (including the results of the observational studies).

EMA will communicate further when appropriate.