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GLP-1 medicines and diabetic retinopathy: what the labels and the SUSTAIN-6 trial report

The direct answer · last checked 7 October 2026

The Wegovy label warns of diabetic retinopathy complications in people with type 2 diabetes, and the Zepbound and Foundayo labels both say temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. The Wegovy label reports that in a 2-year trial of semaglutide injection in adults with type 2 diabetes, diabetic retinopathy complications occurred in 3% of treated patients versus 1.8% on placebo, with a larger absolute increase in patients who already had retinopathy. The underlying SUSTAIN-6 trial reported a hazard ratio of 1.76 (95% CI 1.11 to 2.78) for retinopathy complications. The Wegovy and Zepbound labels say people with a history of diabetic retinopathy should be monitored for progression. If you have diabetes, tell your prescriber and eye specialist about your treatment, and keep your regular eye exams.

Most coverage of GLP-1 medicines focuses on weight and the stomach. A less discussed warning concerns the eye. It matters mainly to people who have type 2 diabetes, especially those who already have some retinopathy, and it comes from a specific, well-documented trial finding rather than from speculation. This article explains what the Wegovy, Zepbound and Foundayo labels say about diabetic retinopathy, what the SUSTAIN-6 trial found, what is still being studied, and what to ask your clinicians. It cannot say whether the medicine is right for you; that decision belongs with your prescriber and, if you have eye disease, your eye care professional.

What diabetic retinopathy is

Diabetic retinopathy is damage to the blood vessels of the retina, the light-sensing tissue at the back of the eye, caused by diabetes. The National Institute of Diabetes and Digestive and Kidney Diseases says early retinopathy involves weakened, bulging or leaking blood vessels in the retina and that often there are no early symptoms of diabetic eye disease, so damage can develop without pain or vision changes. It also says most people with diabetes should see an eye care professional once a year for a complete eye exam, with exams for type 2 diabetes starting right after diagnosis, and that your eye care professional may recommend more frequent exams (NIDDK: Diabetic Eye Disease).

That symptom-free early phase is why this label warning is hard to act on without a dilated eye exam. You cannot rely on noticing a change yourself.

What each label says

The Wegovy label (revised 06/2026), section 5.8, “Diabetic Retinopathy Complications,” gives the most detail:

  • In a 2-year trial of once-weekly semaglutide 0.5 mg and 1 mg injection in adults with type 2 diabetes, diabetic retinopathy complications occurred in patients treated with semaglutide injection (3%) compared with placebo (1.8%).
  • The absolute risk increase was larger among patients with a history of diabetic retinopathy.
  • In a weight-reduction trial in adults with type 2 diabetes and a BMI of at least 27 kg/m² (Study 3), diabetic retinopathy was reported by 4% of Wegovy injection-treated patients and 2.7% of those on placebo.
  • Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.
  • Patients with a history of diabetic retinopathy should be monitored for progression.

The Zepbound label (revised 08/2026), section 5.8, says temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control, and that patients with a history of diabetic retinopathy should be monitored for progression. The section as retrieved gives no trial percentages for retinopathy. Section 5.7 separately tells prescribers to monitor blood glucose before and during treatment in patients with diabetes.

The Foundayo label (orforglipron tablets, revised 07/2026), section 5.7, says temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control, and that Foundayo has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment.

Notice what the labels do and do not say. They do not say the medicines cause eye disease in people without diabetes, and they do not contraindicate use in people with retinopathy. They flag a risk in a particular group and ask for monitoring.

The trial behind the warning: SUSTAIN-6

The 3% versus 1.8% figures in the Wegovy label correspond to the SUSTAIN-6 cardiovascular outcomes trial, published in the New England Journal of Medicine in 2016 (Marso and colleagues). It randomly assigned 3,297 patients with type 2 diabetes to once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks. The trial was designed to test cardiovascular safety, and the primary outcome of cardiovascular death, nonfatal heart attack or nonfatal stroke occurred in 6.6% of the semaglutide group and 8.9% of the placebo group (hazard ratio 0.74, 95% CI 0.58 to 0.95). Rates of new or worsening nephropathy were lower in the semaglutide group.

The same paper reported that rates of retinopathy complications (defined as vitreous hemorrhage, blindness, or conditions requiring treatment with an intravitreal agent or photocoagulation) were significantly higher with semaglutide (hazard ratio 1.76, 95% CI 1.11 to 2.78, P=0.02). The trial was funded by Novo Nordisk. The study was not designed around eye outcomes: retinopathy was a safety finding, which is one reason further research was launched.

Why would a medicine that helps heart and kidney outcomes be linked to worse eye outcomes? The Wegovy label points to one explanation, that rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The labels stop short of saying that this is the whole story, and we are not aware of a source that settles the mechanism, so we do not speculate.

What is still being studied

The FOCUS trial is a dedicated study of semaglutide and diabetic eye disease. According to its ClinicalTrials.gov record, last updated on 7 October 2026, FOCUS is a Novo Nordisk-sponsored study comparing once-weekly semaglutide with placebo, added to usual diabetes care, over five years in adults with type 2 diabetes. Its primary outcome is the percentage of participants with at least a 3-step progression on the ETDRS diabetic retinopathy scale at year 5. The record lists its status as active, not recruiting, with an estimated primary completion date of 7 November 2027, and no results are posted. Until it reports, the best available answer to “how large is the eye risk?” remains the SUSTAIN-6 finding plus the label language, with the caveat that a trial designed for another purpose gave the signal.

Who should pay the most attention

  • People with type 2 diabetes who already have retinopathy. The Wegovy label says the absolute risk increase was larger in patients with a history of retinopathy. Monitoring for progression is what the Wegovy and Zepbound labels ask for.
  • People whose blood sugar is high and will fall quickly. The labels tie temporary worsening to rapid improvement in glucose control. Ask your prescriber how quickly your glucose is expected to fall and whether an eye exam should come first.
  • People taking a medicine for weight management who also have diabetes. The Wegovy label reports retinopathy in 4% on Wegovy versus 2.7% on placebo in a weight-reduction trial in adults with type 2 diabetes.
  • People without diabetes. The sections reviewed describe the warning in the context of diabetes, so this is mainly a question for people with diabetes. If you have any eye condition or have noticed vision changes, tell your prescriber anyway.

Practical steps to discuss

  • Get a dilated eye exam before starting if you have diabetes and have not had one recently. NIDDK advises a complete eye exam once a year for most people with diabetes, and early disease can be symptom-free, so a baseline helps your clinicians interpret later changes.
  • Tell your eye care professional what you are taking and when you started or changed dose. Many eye specialists work separately from the prescriber, and the two may not know about each other.
  • Ask how often you should be seen. NIDDK says your eye care professional may recommend more frequent exams. The labels say to monitor for progression but do not set a schedule.
  • Report sudden vision changes promptly. The labels do not list symptoms in the sections we reviewed, so rely on your eye care professional’s guidance on which changes to treat as urgent.
  • Do not stop diabetes medicine on your own. Uncontrolled glucose itself damages the retina over time, which is why the question is how to improve control safely, not whether to improve it.

The same diligence applies to the other label warnings: see pancreatitis, gallbladder disease, and, for how coverage choices affect which medicine you end up on, how to appeal a prior authorization denial.

Common misunderstandings

  • “The labels say these medicines cause blindness.” The Wegovy label describes diabetic retinopathy complications in a trial in people with type 2 diabetes, and SUSTAIN-6 counted vitreous hemorrhage, blindness, and conditions needing eye treatment together as one outcome. It is not a statement about the general population.
  • “It only affects Novo Nordisk’s medicine.” The Zepbound and Foundayo labels also carry a diabetic retinopathy warning about temporary worsening with rapid glucose improvement, though they report no matching trial percentages in the sections we retrieved. Do not compare the numbers across labels.
  • “The worsening is permanent.” The labels describe temporary worsening associated with rapid glucose improvement. SUSTAIN-6 counted events that needed treatment, which can have lasting consequences, so ask your eye specialist what to expect.
  • “If I have no symptoms, I do not need an eye exam.” NIDDK says there are often no early symptoms.
  • “The FOCUS trial already settled it.” Its record lists no posted results and an estimated primary completion in November 2027.

Finding a provider and care team to coordinate eye care

If you have diabetes, your prescriber and your eye doctor both matter here. When choosing a service, compare how each handles medical history in our clinical quality comparison and our most trusted GLP-1 providers page. For insurance-based care, see GLP-1 providers that accept insurance; for who prescribes which medicine, see which providers carry oral GLP-1s. Individual write-ups include LifeMD vs. Ro, whether IVIM Health is legit, and whether Allara Health is legit. Browse them all in the GLP-1 provider directory. Our provider pages are editorial resources, not recommendations; see our advertiser disclosure and editorial standards for how they are produced.

Questions people ask

Does the diabetic retinopathy warning apply to Zepbound?

Yes. Section 5.8 of the Zepbound label says temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control and that patients with a history of retinopathy should be monitored.

Does the Foundayo label say anything different?

Section 5.7 reports the same temporary-worsening statement and adds that Foundayo has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment.

Should I see an eye doctor before starting?

If you have diabetes, NIDDK advises most people to have a complete eye exam once a year. Ask your prescriber whether an exam before starting makes sense for you, especially if you already have retinopathy.

Is this a reason to avoid GLP-1 medicines if I have diabetes?

The labels do not contraindicate use. They ask for monitoring in people with a history of retinopathy. The decision depends on your eye health, your glucose control and your other conditions, so make it with your prescriber and eye care professional.

Sources

  1. U.S. FDA labeling, Wegovy prescribing information (revised 06/2026), section 5.8, checked 7 October 2026.
  2. U.S. FDA labeling, Zepbound prescribing information (revised 08/2026), sections 5.7 and 5.8, checked 7 October 2026.
  3. U.S. FDA labeling, Foundayo prescribing information (revised 07/2026), section 5.7, checked 7 October 2026.
  4. Marso SP et al., Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6), New England Journal of Medicine, 10 November 2016 (DOI 10.1056/NEJMoa1607141).
  5. ClinicalTrials.gov, FOCUS: semaglutide and diabetic eye disease (NCT03811561), record updated 7 October 2026.
  6. National Institute of Diabetes and Digestive and Kidney Diseases, Diabetic Eye Disease, checked 7 October 2026.

Medical disclaimer. This article is informational and is not medical advice. It does not replace an eye examination or a conversation with your prescriber. Sudden changes in vision need prompt medical attention. Do not start, stop or change a prescribed medicine without instructions from your prescriber.

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