Can you summarize available data/risk regarding semaglutide (Ozempic) and vision loss? Has this only been connected to patients with new or underlying retinopathy?

Comment by InpharmD Researcher

Evidence regarding retinopathy associated with semaglutide therapy is conflicting. Data regarding retinopathy primarily come from the SUSTAIN-6 trial, which reports a significantly increased risk of diabetic retinopathy in the semaglutide cohort; however, patients who are at increased risk of retinopathy development (e.g., advanced age, higher HbA1c levels) were included, and thus retinopathy incidence cannot be isolated to semaglutide exposure. Risk of retinopathy in patients treated with semaglutide who had no known pre-existing diabetic retinopathy prior to therapy is reportedly low.

Background

Semaglutide, a glucagon-like peptide 1 receptor agonists (GLP-1 RA), has been reported to be associated with a reduction in the development of retinopathy with HbA1c reduction, although data is conflicting; some literature report transient paradoxical worsening of diabetic retinopathy in patients with type 2 diabetes mellitus (T2DM) prior to seeing benefits with glucose control in cohorts who had pre-existing diabetic retinopathy progression. The SUSTAIN-6 trial, which evaluated retinopathy as a secondary outcome measure with subcutaneous semaglutide therapy, reported a significantly increased risk of diabetic retinopathy in the semaglutide group versus placebo; however, this may be due to the lack of consideration for HbA1c limits or pre-existing diabetic retinopathy as patient exclusion criteria in SUSTAIN-6, and thus the inclusion of older patients with higher baseline HbA1c levels, longer duration of diabetes, and more advanced diabetic retinopathy at baseline may have influenced diabetic retinopathy progression and observation. In patients with no known pre-existing diabetic retinopathy at baseline who were treated with semaglutide, risk of diabetic retinopathy was low, and matched the event incidence of diabetic retinopathy in the placebo group. Further research is required to ascertain the extent of diabetic retinopathy risk with semaglutide therapy. [1], [2], [3]

A 2022 meta-analysis evaluated the association between semaglutide and the risk of retinopathy in patients with T2DM, assessing data from 23 randomized trials (N= 22,096 patients). Follow-up periods ranged from 15.9 to 104 weeks. In total, 730 cases of diabetic retinopathy events were identified, with 463 events from patients taking semaglutide and 267 in the control cohort. Pooled data from the trials did not find the semaglutide cohort to be at an increased risk of diabetic retinopathy events versus controls (risk ratio [RR] 1.14; 95% confidence interval [CI] 0.98 to 1.33), though patient aged ≥60 years and diabetes duration ≥10 years were independent risk factors for diabetic retinopathy when taking semaglutide. Additionally, a subgroup analysis found semaglutide to be associated with diabetic retinopathy when compared to placebo (RR 1.23; 95% CI 1.03 to 1.50). The investigators recommend paying additional attention when initiating semaglutide treatment in older patients or patients with longer duration of diabetes, but overall note that semaglutide is not suggested to be associated with an increased risk of retinopathy. Whether these findings correlate to new or underlying retinopathy is uncertain. [4]

Though not specific to semaglutide’s effects in specific, a 2022 systematic review and meta-analysis sought to evaluate the effect of GLP-1 RAs on diabetic retinopathy. Thirteen randomized trials were included, of which ten assessed the effects of semaglutide (4 injection, 6 oral). Overall, GLP-1 RAs were associated with worsening diabetic retinopathy despite reporting cardiovascular benefits (odds ratio [OR] 1.23; 95% CI 1.05 to 1.44), with a greater association between GLP-1 RAs and diabetic retinopathy in trials with follow-up durations past 52 weeks which used placebo as a comparator. Based on these findings, diabetic retinopathy may not be agent- or administration route-specific, though included studies varied in utilized comparators, T2DM durations, follow-up periods, and sample sizes. [5]

References:

[1] Cigrovski Berkovic M, Strollo F. Semaglutide-eye-catching results. World J Diabetes. 2023;14(4):424-434. doi:10.4239/wjd.v14.i4.424
[2] Sharma A, Parachuri N, Kumar N, et al. Semaglutide and the risk of diabetic retinopathy-current perspective. Eye (Lond). 2022;36(1):10-11. doi:10.1038/s41433-021-01741-5
[3] Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834-1844. doi:10.1056/NEJMoa1607141
[4] Wang F, Mao Y, Wang H, Liu Y, Huang P. Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. Clin Drug Investig. 2022;42(1):17-28. doi:10.1007/s40261-021-01110-w
[5] Yoshida Y, Joshi P, Barri S, et al. Progression of retinopathy with glucagon-like peptide-1 receptor agonists with cardiovascular benefits in type 2 diabetes - A systematic review and meta-analysis. J Diabetes Complications. 2022;36(8):108255. doi:10.1016/j.jdiacomp.2022.108255

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

Can you summarize available data/risk regarding Ozempic and vision loss? Has this only been connected to patients with new or underlying retinopathy?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-2 for your response.


 

Long-term use of semaglutide and risk of diabetic retinopathy progression

Design

Retrospective, observational study

N= 87 patients (174 eyes)

Objective

To assess the association between semaglutide use and the risk of diabetic retinopathy (DR) progression over three years in patients with type 2 diabetes (T2D)

Study Groups

All study subjects (N= 87)

Inclusion Criteria

At least 1 year of semaglutide use, documentation of non-proliferative (NPDR) and proliferative (PDR) retinopathy levels, visual acuity (VA), and Central Subfield Thickness (CST)

Exclusion Criteria

Incomplete records or less than one year of semaglutide use
Methods

Data was sourced from a specialized ophthalmology retina practice using the MDIntelleSys (MDI) EMR system. The study included T2D patients with DR confirmed by ICD-10 codes. Eligible patients were examined for demographic data, baseline DR severity using Diabetic Retinopathy Severity Scale (DRSS), changes in retinopathy levels, VA, CST, and the need for intravitreal anti-VEGF injections.

Duration

January 2020 to June 2020

Average duration of semaglutide use: 2.9 years

Outcome Measures

Primary: Progression to PDR

Secondary: Visual acuity changes, number of intravitreal injections

Baseline Characteristics  

All study subjects (N= 87)

Age, years (range)

62.4 (38-84)

Female

36 (41.4%) 

Race

Caucasian

Black

Other

Hispanic

 

73 (83.9%)

10 (11.5%)

4 (4.6%)

9 (10.3%)

Baseline HbA1c, %

7.6 ± 1.1

Last Recorded HbA1c, %

7.4 ± 1.5

No significant distinction observed in the means and standard deviations between the baseline HbA1c and the last follow-up HbA1c (p= 0.4949).

Results

DRSS Level

Baseline Progression to PDR, n (%)

10–43

75 2 (2.7%)

47–53

25 7 (28%)

61–85

74 33 (44.6%)

About 3.4% showed improvement with less severe retinopathy, while 73.6% maintained stable DR levels without worsening during the study.

In the cohort referred for DR management, 67.8% required intravitreal anti-VEGF injections, reflecting the prevalence of diabetic macular edema or advanced PDR. On average, patients received 12.6 injections over about three years. 

Analysis of visual acuity showed that 72.4% of patients had stable vision, 16.1% lost two or more lines in at least one eye, and 11.5% gained two or more lines of vision during the study.

Adverse Events

See Results

Study Author Conclusions

Semaglutide use was not associated with an increased risk of DR progression, visual loss, or an increased number of intravitreal injections over a 3-year period.

Critique

Study limitations include potential referral bias, as participants were referred for specialized DR management. Patient compliance with semaglutide is unclear, and some in the control group may have used the medication without informing their provider. Comparisons across A1c levels may limit applicability to the broader diabetes population. Additionally, medication adherence and the focus on specialized care patients restrict generalizability. The study's primary question—whether DR progression is linked to semaglutide or its metabolic effects—cannot be fully answered, as data on metabolic regulation were not collected, preventing definitive conclusions.

References:

Stevens H, de la Paz M, Cooper B, Bhattachartya R. Long-term use of semaglutide and risk of diabetic retinopathy progression. Endocr Metab Sci. 2024;15:100168. doi:10.1016/j.endmts.2024.100168

 

Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide

Design

Retrospective matched cohort study

N= 16,827 

Objective

To investigate whether there is an association between semaglutide and the risk of nonarteritic anterior ischemic optic neuropathy (NAION)

Study Groups

Semaglutide (n= 194)

Non-glucagon-like peptide 1 receptor agonist (non-GLP-1 RA; n= 516)

Inclusion Criteria

Age >12 years old; evaluated by neuro-ophthalmologists with no history of NAION, with T2D or overweight/obesity

Exclusion Criteria

Patients with a history of NAION prior to the study start date

Methods

Patients were identified from a clinical registry. Propensity score matching was used to balance cohorts based on covariates including age, sex, hypertension, diabetes, obstructive sleep apnea, obesity, and coronary artery disease. 

Duration

December 1, 2017 to November 30, 2023

Outcome Measures

Cumulative incidence and hazard ratio of NAION

Baseline Characteristics

 

Semaglutide (n= 194)

Non–GLP-1 RA (n= 516)

Age, years (IQR)

56 (47-63) 61 (50-70)

Female

110 (57%) 259 (50%) 

Race

Asian

Black

White

Other

 

5 (3%)

31 (16%)

134 (69%)

24 (12%) 

 

28 (5%)

41 (8%)

375 (73%)

72 (14%) 

Comorbidities 

Systemic hypertension

Obstructive sleep apnea

Obesity

Hyperlipidemia

Coronary artery disease

Chronic kidney disease

MEN type 2

Thyroid tumors

Pancreatitis 

 

160 (82%)

82 (42%)

157 (81%)

140 (72%)

100 (52%)

53 (27%)

0

1 (1%)

16 (8%)

 

369 (72%)

115 (22%)

177 (34%)

289 (56%) 

211 (41%)

101 (20%)

0

5 (1%)

31 (6%) 

Amiodarone exposure

25 (13%) 36 (7%)

PDE5 inhibitor exposure

26 (13%) 37 (7%) 

Abbreviations: IQR, interquartile range;GLP-1 RA, glucagon-like peptide 1 receptor agonist; MEN, multiple endocrine neoplasia; NAION, nonarteritic anterior ischemic optic neuropathy; PDE5, phosphodiesterase type 5

Baseline characteristics provided are prior to propensity score matching. 

Results

Endpoint

Semaglutide (n= 194)

Non–GLP-1 RA (n= 516)

Cumulative incidence of NAION

(95% confidence interval [CI])

8.9% 

(4.5 to 13.1)

1.8%

(0 to 3.5)

A Cox proportional hazards regression model revealed that patients receiving semaglutide had a significantly higher risk of developing NAION compared to those not on semaglutide, with a hazard ratio of 4.28 (95% CI 1.62 to 11.29; p< 0.001).

Among overweight or obese patients, 20 NAION events were reported in the semaglutide group, compared to 3 events in the non–GLP-1 RA group.

Adverse Events

N/A

Study Author Conclusions

This study’s findings suggest an association between semaglutide and NAION. As this was an observational study, future study is required to assess causality

InpharmD Researcher Critique

Limitations include the study's focus on a specialized neuro-ophthalmology center, which may affect the generalizability of the findings to broader healthcare settings. The retrospective design did not allow for control over potential biases in prescribing semaglutide or patient referrals. Additionally, nonadherence to medications and small sample sizes may have contributed to reduced precision in the results, leading to wide confidence intervals.



References:

Hathaway JT, Shah MP, Hathaway DB, et al. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmol. 2024;142(8):732-739. doi:10.1001/jamaophthalmol.2024.2296