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Emerging vision risks linked to semaglutide, tirzepatide
Recent data points to potential ophthalmic complications, including optic neuropathy and maculopathy, in patients treated with semaglutide and tirzepatide.
In recent years, semaglutide and tirzepatide have quickly emerged as leading therapies in the management of type 2 diabetes and obesity. These incretin-based therapies, known for their glucagon-like peptide 1 receptor and gastric inhibitory peptide receptor activity, provide significant benefits in improving glycemic control and promoting weight loss. However, recent findings indicate potential ophthalmic complications associated with their use, raising new questions about patient safety and drug risk management.
Study findings
A recent case series involving nine patients offers insights into possible ocular complications linked to semaglutide and tirzepatide. Although causality has not been definitively established, the following patterns emerged.
- Nonarteritic anterior ischemic optic neuropathy (NAION). Reported in seven patients, NAION is a condition that results in sudden vision loss due to optic nerve infarction. Some cases presented atypical features, including bilateral optic disc swelling and progressive vision loss.
- Papillitis (optic disc inflammation). One patient experienced bilateral papillitis, with swelling of the optic nerve heads.
- Paracentral acute middle maculopathy. One case involved this rare retinal condition, characterized by retinal capillary ischemia, leading to loss of vision in the affected area.
A closer look at mechanism and risk
The mechanism driving these complications remains unclear. One hypothesis suggests that the rapid correction of hyperglycemia -- a hallmark of these therapies -- may contribute to optic nerve ischemia and swelling. Notably, rapid reductions in hemoglobin A1c (HbA1c) levels have been previously associated with complications such as diabetic papillitis.
In the case series, patients experienced significant decreases in HbA1c, ranging from baseline levels of 8.4%-10.2% down to 5.5%-6.7% after beginning treatment. This substantial improvement in glycemic control could create ischemic stress on the optic nerve and retinal tissues.
Industry implications
Given the widespread use of these drugs, increased vigilance is warranted. Nearly 2% of the U.S. population received a prescription for semaglutide in 2023, reflecting the drug’s rapid adoption. Semaglutide alone accounted for $38 billion in pharmaceutical expenditures in 2023, representing 100% growth compared to 2022. Despite the significant benefits of semaglutide and tirzepatide, concerns about potential ocular risks must be balanced with their therapeutic value.
The American Academy of Ophthalmology has recommended that patients experiencing vision changes while taking these medications stop their treatment and seek immediate medical attention. Although no regulatory action has been taken to restrict these therapies, there is a growing consensus that postmarketing surveillance is necessary to provide deeper insights into these complications.
Pharmaceutical companies should collaborate with healthcare providers to develop patient screening protocols, particularly for those with preexisting ocular conditions like diabetic retinopathy. A structured postmarketing study could offer a clearer understanding of these adverse events and help guide clinical decisions. Educating patients about the potential risks and symptoms to watch for -- such as sudden vision changes -- can further reduce the chances of irreversible damage and improve outcomes.
While no regulatory actions have been taken to restrict the use of these therapies, the American Academy of Ophthalmology has recommended heightened monitoring for patients who experience vision changes while on these medications. A postmarketing surveillance study could help clarify the extent and mechanisms of these potential adverse effects.
Key takeaways
- Risk mitigation strategies. Pharmaceutical companies should collaborate with healthcare providers to develop patient screening protocols, especially for those with preexisting ocular conditions such as diabetic retinopathy.
- Postmarketing surveillance. A structured postmarketing study could provide a more comprehensive understanding of these complications, informing clinical guidelines and prescribing practices.
- Patient education. Ensuring that patients are aware of potential symptoms, such as sudden vision changes, and encouraging them to seek immediate medical attention could reduce the risk of irreversible damage.
Semaglutide and tirzepatide are undoubtedly groundbreaking advancements in the treatment of type 2 diabetes and obesity, but their widespread use calls for careful monitoring and ongoing research. As the industry continues to explore the full scope of these therapies' impact, maintaining open communication between pharmaceutical companies, healthcare providers and regulatory bodies will be essential in optimizing patient outcomes and mitigating risks.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
