FDA Orders Vision-Loss Warning Labels on GLP-1 Drugs Including Ozempic and Zepbound

The U.S. Food and Drug Administration on November 9 ordered the makers of blockbuster GLP-1 drugs to add warnings about a rare but potentially permanent eye condition to their product labels. Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro and Zepbound are among the drugs affected, with new language required in the "warnings and precautions" section covering the risk of non-arteritic anterior ischemic optic neuropathy, or NAION, a condition that can cause permanent vision loss.

The FDA's analysis found 6.4 cases of NAION per 100,000 patient-years among GLP-1 users compared with 3.8 in a control group, representing a roughly 70 percent higher rate. A large study published in 2025 tracking nearly 175,000 diabetic patients treated with semaglutide found that NAION risk more than doubled after two years of treatment relative to patients on other diabetes drug classes. The FDA's safety committee described the condition as very rare, estimating it may affect up to 1 in 10,000 people taking semaglutide.

The GLP-1 warning action was the most market-sensitive development among a busy day of clinical readouts. ImmunityBio reported that ANKTIVA plus BCG met the primary endpoint in its QUILT-2.005 registrational trial in BCG-naive, high-grade non-muscle invasive bladder cancer patients, and separately won Israeli Ministry of Health approval for ANKTIVA in BCG-unresponsive NMIBC with carcinoma in situ. Zura Bio disclosed that its tibulizumab drug candidate failed the Phase 2 TibuSHIELD trial in hidradenitis suppurativa, missing both the primary endpoint of abscess and nodule count reduction at week 16 and key secondary endpoints including HiSCR50 and HiSCR75; the company said it is discontinuing tibulizumab's development in that indication and noted cash of 187.7 million dollars, with data from the ongoing TibuSURE study in systemic sclerosis expected in the first half of 2027. Zura Bio shares were indicated down roughly 68 percent before the open.

Novocure received a Not Approvable Letter from the FDA for its Optune Mya device in brain metastases from non-small cell lung cancer, with the agency citing uncertainty around the degree of clinical benefit. Merck announced positive Phase 2b results for efinopegdutide in MASH with stage 2 to 3 fibrosis, showing liver fibrosis improvement without worsening of steatohepatitis at 52 weeks. Argenx reported that efgartigimod met its primary endpoint in the Phase 3 ALKIVIA trial in autoimmune myositis, covering both immune-mediated necrotizing myopathy and dermatomyositis patients. Boehringer Ingelheim's survodutide became the first glucagon and GLP-1 dual agonist to demonstrate a favorable cardiovascular safety profile in a global Phase 3 cardiovascular outcomes trial, the SYNCHRONIZE-CVOT study.