Drug Injury Watch

Current FDA Safety Investigation: NAION With Mounjaro, Zepbound, and Other GLP-1 RAs

Evaluating Glucagon-like Peptide-1 (GLP-1) Receptor Agonists for Possible Risk of NAION Side Effects

 

(Posted by Tom Lamb at Drug Injury Watch)

 

The FDA has been investigating "potential signals" of non-arteritic anterior ischemic optic neuropathy (NAION) with the glucagon-like peptide-1 (GLP-1) receptor agonist class of drugs. For example, NAION with Mounjaro, Zepbound, Wegovy, Rybelsus, and Ozempic.

From "October - December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)", here is a full list of the glucagon-like peptide-1 (GLP-1) receptor agonists, or GLP-1 RAs, that are being evaluated:

Adlyxin (lixisenatide) injection
Bydureon (exenatide) for extended-release injectable suspension
Bydureon BCise (exenatide extended-release) injectable suspension
Byetta (exenatide) injection
Mounjaro (tirzepatide) injection
Ozempic (semaglutide) injection
Rybelsus (semaglutide) tablets
Saxenda (liraglutide) injection
Soliqua 100/33 (insulin glargine and lixisenatide) injection
Trulicity (dulaglutide) injection
Victoza (liraglutide) injection
Wegovy (semaglutide) injection
Xultophy 100/3.6 (insulin degludec and liraglutide) injection
Zepbound (tirzepatide) injection

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Mounjaro / Zepbound

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In early June 2025, the European Medicines Agency (EMA) confirmed the link between the semaglutide-containing drugs Wegovy, Rybelsus, and Ozempic and NAION (non-arteritic anterior ischemic optic neuropathy). This drug regulator went on to say a NAION warning would be added to the drug labels for Wegovy, Rybelsus, and Ozempic in Europe.

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Ozempic / Wegovy / Rybelsus

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We have posted several articles on Drug Injury Watch during the past year about NAION linked to Ozempic, Rybelsus, and Wegovy:

• March 2025 Medical Article About Blindness or Vision Loss Linked to Ozempic and Rybelsus Use by Diabetes Patients (3/31/25)
• Ozempic Vision Problems From Semaglutide Apply to Wegovy and Rybelsus, Also (2/21/25)
• Novo Nordisk Semaglutide Drug Ozempic Linked to Vision Loss, Doubling the Risk: December 2024 Update (12/18/24)
• Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION (7/5/24)

As seen in those articles, the link between the semaglutide-containing drugs and NAION is fairly well-established by this point in time.

This is our first consideration of NAION with Mounjaro, Zepbound, and other GLP-1 RAs besides Wegovy, Rybelsus, and Ozempic.

We will monitor the FDA, the EMA, and other drug regulators, as well as the relevant medical literature, for developments concerning a possible association of NAION with the tirzepatide-containing drugs Mounjaro and Zepbound as well as those various drugs with the active ingredients dulaglutide, exenatide, liraglutide, and lixisenatide (see the above list for brand-name information).

If you have developed NAION with Mounjaro, Zepbound, or other GLP-1 RAs -- including Wegovy, Rybelsus, and Ozempic -- there might be a drug injury lawsuit against the responsible pharmaceutical company. Please don't hesitate to contact us if you are interested in such a case.

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Advisory: AION Vision Side Effect: Ozempic, Wegovy, Rybelsus

The Eye Condition AION Diagnosis Can Include NAION Due to Semaglutide Use

 

(Posted by Tom Lamb at Drug Injury Watch)

 

This article discusses a lesser-known possible vision side effect for Ozempic, Wegovy, and Rybelsus, diagnosed as anterior ischemic optic neuropathy (AION). As will be shown below, an eye condition AION diagnosis can include nonarteritic anterior ischemic optic neuropathy (NAION) due to semaglutide use by diabetes patients or people using semaglutide-containing drugs for weight loss.

We have written several times previously about patients who used Ozempic, Wegovy, or Rybelsus and then developed vision loss and blindness due to NAION. In those earlier articles, we pointed out:

1. Semaglutide is the active ingredient in all three of these Novo Nordisk drugs; and,
2. The current drug labels for Ozempic, Wegovy, and Rybelsus do not warn about NAION as a possible eye-related side effect.  (Likewise, there is no warning about AION.)

As regards the relationship between an AION diagnosis and NAION, we get the following from this medical journal article, "Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy", published by the Survey of Ophthalmology back in 2010:

Anterior ischemic optic neuropathy (AION) results from ischemic damage to the anterior portion of the optic nerve, a region primarily supplied by the posterior ciliary artery circulation. Anterior ischemic optic neuropathy is divided into two types: arteritic AION (AAION), secondary to vasculitis (especially giant cell arteritis), and nonarteritic AION (NAION), secondary to non-inflammatory small vessel disease. NAION constitutes 95% of all AION and is the most common cause of acute optic neuropathy in people over the age of 50, affecting somewhere between 2 to 10 individuals per 100,000 (approximately 1500 to 6000 new cases per year in the United States). [Emphasis added; footnotes omitted.]

Accordingly, a person using Rybelsus, Wegovy, or Ozempic diagnosed with AION might have NAION due to semaglutide use and, in turn, could have a potential drug injury lawsuit against Novo Nordisk.

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Ozempic / Wegovy / Rybelsus

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The fundamental basis for such a drug injury lawsuit is the fact that there is no warning about anterior ischemic optic neuropathy (AION) as a possible eye-related side effect in the current drug labels for Ozempic, Wegovy, and Rybelsus. More information about these lawsuits against the drug company is in our April 2025 article "Ozempic Vision Loss Lawsuits Have Been Filed by Patients Against Novo Nordisk".

Unfortunately, people diagnosed with anterior ischemic optic neuropathy (AION) often experience some degree of permanent vision impairment, just like those diagnosed with nonarteritic anterior ischemic optic neuropathy (NAION).

If you have been diagnosed with AION, or NAION, we can assist you with a possible drug injury lawsuit that would be filed against Novo Nordisk, the responsible pharmaceutical company.

These drug injury lawsuits would not be filed against the prescribing doctor or eye doctors treating the eye-related drug side effect, given the "failure to warn" situation that serves as the basis for these legal compensation cases.

To get started, you can complete our online Case Evaluation Form, or you can call attorney Tom Lamb (910-256-2971) to discuss your possible case.

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March 2025 Medical Article About Blindness or Vision Loss Linked to Ozempic and Rybelsus Use by Diabetes Patients

Discusses Timing for Increased Risk of Semaglutide-related Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) Side Effect

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On March 27, 2025, the JAMA Ophthalmology medical journal published a report about a recent medical study examining the relatively new drug safety issue of vision loss and blindness due to NAION linked to Ozempic and Rybelsus use by patients with type 2 diabetes. As stated in the Abstract for this article, "Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy Risk Among Patients With Diabetes", the Objective of that medical study was "To investigate the association between semaglutide use and the risk of NAION among patients with diabetes."

Here are earlier Drug Injury Watch articles about vision loss and blindness due to NAION linked to Ozempic and Rybelsus, as well as Wegovy, another semaglutide-containing drug:

• Ozempic Vision Problems From Semaglutide Apply to Wegovy and Rybelsus, Also (2/21/25)
• Novo Nordisk Semaglutide Drug Ozempic Linked to Vision Loss, Doubling the Risk: December 2024 Update (12/18/24)
• Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION (7/5/24)

We begin this new article about NAION linked to Ozempic and Rybelsus by presenting this summary from the Conclusions and Relevance part of the Abstract for the recent March 2025 JAMA Ophthalmology medical journal article:

Results of this cohort study suggest that semaglutide use was associated with an increased risk of NAION in patients with diabetes. However, the study’s retrospective design presents limitations, as it can only infer associations rather than establish causality; further studies are needed.

Going deeper into the full-text of this semaglutide-NAION medical study article, we point out the time relationship between Ozempic and Rybelsus use dates by patients with type 2 diabetes and the diagnosis dates for their NAION. From the Results section of that March 2025 JAMA Ophthalmology article, a part titled "Risk of NAION in Terms of Follow-Up Duration After Semaglutide Prescription" sets forth information about this timing aspect:

No increased risk was seen among patients with diabetes who received semaglutide at the 1-month (HR, 2.99; 95% CI, 0.31-28.75), 3-month (HR, 1.33; 95% CI, 0.30-5.93), 6-month (HR, 1.79; 95% CI, 0.60-5.35), and 1-year time points (HR, 1.94; 95% CI: 0.93-4.02) after the index date when compared with those receiving non–GLP-1 RA medication. However, among patients with diabetes, an increased risk for NAION was associated with use of semaglutide at the 2-year (HR, 2.39; 95% CI, 1.37-4.18), 3-year (HR, 2.44; 95% CI, 1.44-4.12), and 4-year (HR, 2.05; 95% CI, 1.26-3.34) time points from the index date compared with use of the non–GLP-1 RA medications (Table 1). Across the entire study duration, there was an increased risk for NAION associated with semaglutide use among patients with diabetes compared with non–GLP-1 RA users (HR, 2.22; 95% CI, 1.37-3.60). Kaplan-Meier curve analysis revealed that among patients with diabetes, there was an increased risk for NAION associated with semaglutide use compared with non–GLP-1 RA use at 2-year, 3-year, and 4-year follow-up from the index date (Figure 1 and Figure 2).

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Ozempic / Wegovy / Rybelsus

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This timing information for the semaglutide-related nonarteritic anterior ischemic optic neuropathy (NAION) side effect of Ozempic and Rybelsus use by diabetes patients suggests we may have a still-emerging drug injury lawsuit situation here. In more detail, given the growing blockbuster status of Ozempic and Rybelsus in combination with the apparent delay in onset of vision loss and blindness leading to a NAION diagnosis, it seems we are just at the start of hearing from patients who have suffered this eye-related side effect and who want to obtain legal compensation.

We have been investigating possible drug injury lawsuits for patients who developed vision loss and blindness due to NAION eye-related side effects of Ozempic and Rybelsus, two of three semaglutide-containing drugs from Novo Nordisk. (The other is Wegovy, approved by the FDA as a treatment for adult obesity and used for weight loss.)

Drug injury lawsuits involving Ozempic, Rybelsus, or Wegovy filed for patients with vision loss due to nonarteritic anterior ischemic optic neuropathy (NAION) would be against Novo Nordisk for its failure to warn about any eye problems, such as vision loss. This is because the current drug labels for Ozempic, Rybelsus, and Wegovy do not warn about NAION as a possible eye-related side effect, resulting in vision loss and blindness.

In turn, as the current drug labels lack any safety warnings about NAION as a possible eye-related side effect for Ozempic, Rybelsus, and Wegovy, these drug injury cases would not be filed against the patients’ prescribing doctors -- or their eye doctors treating the NAION.

Let us know if we can assist you or someone else with an Ozempic, Rybelsus, or Wegovy drug injury case concerning vision loss and blindness due to nonarteritic anterior ischemic optic neuropathy (NAION). One way to do this is to submit an online Case Evaluation Form.

The Brigham and Women's Hospital website provides basic medical information about non-arteritic anterior ischemic optic neuropathy (NAION).  People diagnosed with NAION often experience some degree of permanent vision impairment, which can be life-altering. 

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Ozempic Vision Problems From Semaglutide Apply to Wegovy and Rybelsus, Also

NAION Eye Side Effect Risk Increased With Semaglutide Drugs - Two Recent Medical Studies

 

(Posted by Tom Lamb at Drug Injury Watch)

---

UPDATE: The [European Medicines Agency (EMA)] Pharmacovigilance Risk Assessment Committee (PRAC) reviewed all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials, post-marketing surveillance and the medical literature. PRAC concluded that NAION is a very rare side effect of semaglutide, potentially affecting up to 1 in 10,000 users....

At its May 2025 meeting, the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) also evaluated the evidence and concluded that the Risk Management Plan for semaglutide should be revised to include NAION as a potential risk, including any required additional pharmacovigilance activities.

(6/30/25)

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Two recent medical studies again link the eye side effect of non-arteritic anterior ischemic optic neuropathy (NAION) to semaglutide drugs, providing us with more information about Ozempic vision problems. That is significant because this is still an emerging drug safety issue, which extends to Wegovy and Rybelsus insofar as their active ingredient is semaglutide.

Our first article concerning Ozempic vision problems, "Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION", was posted in July 2024.  Our second article was posted several months later, "Novo Nordisk Semaglutide Drug Ozempic Linked to Vision Loss, Doubling the Risk: December 2024 Update".

In this third article about Ozempic vision problems, we will look at two of the most recent medical studies about semaglutide being associated with an increased risk of NAION. As a preview, the first study found that semaglutide was associated with a higher risk of NAION, having a hazard ratio of 2.19, while the second study "...confirms that use of semaglutide is associated to an increased risk of NAION but also that the excess absolute risk is low.”

The first study was reported in the medical journal International Journal of Retina and Vitreous, in this late 2024 article, "Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes".  From its Abstract we get this overview:

Background
Nonarteritic anterior ischemic optic neuropathy (NAION) is an untreatable condition often causing severe and irreversible visual loss in the affected eye. As it has recently been implied that the use of semaglutide associates with NAION, the aim of the present study was to evaluate this risk prospectively in all persons with type 2 diabetes (T2D) in Denmark.

Conclusions
During five years of observation of all persons with T2D in Denmark, use of once-weekly semaglutide independently more than doubled the risk of NAION. Given the irreversible nature of NAION, it is important to acknowledge this risk, and upcoming studies should aim to identify high-risk subgroups.

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Ozempic / Wegovy / Rybelsus

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The report for that second study is in preprint form and not yet published in a peer-reviewed journal, to our knowledge, but was posted December 11, 2024, online at medRxiv, which calls itself "The Preprint Server for Health Sciences".  From the Abstract for this piece, "Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort study", we get the following:

Question  Is there an association between semaglutide use and risk of non-arteritic anterior ischemic optic neuropathy (NAION)?

Findings  In this cohort study conducted in Denmark and Norway, use of semaglutide was associated with an increased risk of NAION; the pooled hazard ratio was 2.81 (95% confidence interval (CI) 1.67 to 4.75) and the incidence rate difference (absolute risk increase) was +1.41 (95% CI +0.53 to +2.29) NAION events per 10,000 person-years. The finding was consistent across sensitivity and supplementary analysis.

The Brigham and Women's Hospital website provides some basic medical information about non-arteritic anterior ischemic optic neuropathy (NAION).

We are investigating drug injury lawsuits seeking legal compensation for people who received a diagnosis of NAION (non-arteritic anterior ischemic optic neuropathy) while using one of Novo Nordisk's semaglutide drugs, Ozempic, Wegovy, or Rybelsus.

People diagnosed with NAION often experience some degree of permanent vision impairment, which can be life-altering. We encourage you to complete our online Case Evaluation Form so that we can assist you or someone you know with a possible lawsuit involving Rybelsus, Wegovy, or Ozempic vision problems. This service is free and confidential, and there is no obligation. We will reply to you no later than the next business day.  Or you can call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible Ozempic, Wegovy, or Rybelsus drug injury lawsuit.

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Syfovre Injections Side Effects Legal Compensation Cases Being Filed for Patients

Drug Company Apellis Failed to Warn About Retinal Vasculitis Until a November 2023 Label Change

 

(Posted by Tom Lamb at Drug Injury Watch)

 

We are handling Syfovre injections side effects legal compensation cases being filed for patients The basis for these product liability personal injury lawsuits is the drug company Apellis failed to warn about retinal vasculitis until a November 2023 label change.

In more detail, Syfovre (pegcetacoplan) is an eye-injection drug for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) from Apellis Pharmaceuticals. The FDA approved it on February 17, 2023.

Syfovre injections side effects include occlusive retinal vasculitis, which is a type of eye inflammation that blocks blood flow to the retina, resulting in vision loss and potentially causing blindness. There have also been reported cases of non-occlusive retinal vasculitis and other types of eye inflammation.

The Journal of VitreoRetinal Diseases (JVRD), which is the peer-reviewed journal of the American Society of Retina Specialists (ASRS), published a general report on Syfovre retinal-related vision loss, co-authored by members of the ASRS Research and Safety in Therapeutics (ReST) Committee. This report revealed that at least 13 patients had Syfovre retinal-related vision loss in 2023.

That December 2023 JVRD ASRS ReST report article, "Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee", considered 14 eyes of 13 patients who developed retinal vasculitis after their first Syfovre injection. For this set of Syfovre retinal-related vision loss cases, the ASRS ReST report provided these findings:

• 11 eyes were diagnosed as having developed occlusive vasculitis after a Syfovre injection;
• 6 0f 14 eyes had significant vision loss, having lost more than 6 lines of vision; and,
• 2 eyes required enucleation, a surgical procedure that involves the removal of the entire eye.

A November 2023 label change added new Syfovre warnings for retinal vascular occlusion and retinal vasculitis cases associated with Syfovre injections. With these new Syfovre injections side effects warnings, it now seems that the retinal vascular occlusion and retinal vasculitis cases associated with Syfovre use are due to the drug itself and not the injection kits, as had been suggested earlier by Apellis Pharmaceuticals.

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Returning to the American Society of Retina Specialists (ASRS), we get the latest from this July 19, 2024 news report, "The Syfovre Balancing Act. The Retinal Vasculitis Risk Is Real But Research Also Points to Benefits | ASRS 2024":

Last year’s annual meeting of the American Society of Retina Specialists (ASRS) was rocked by news that a small but notable number of patients treated with Syfovre (pegacetacoplan), the first-ever, FDA-approved treatment for geographic atrophy, developed retinal vasculitis, a serious complication that can lead to severe, permanent vision loss. The ASRS Research and Safety in Therapeutics Committee provided an almost day-by-day timeline and details on what was then a handful of cases.

At this year’s ASRS meeting in Stockholm, Sweden, this week, Syfovre’s risks and benefits were still a featured topic but the sense of urgency mellowed into the calmer territory more typical of medical conferences: discrepant findings and differing emphasis on risk and benefits but also points of agreement.

The combined results of two real-world evidence studies presented Thursday put the risk of developing retinal vasculitis at about 1 in every 1,330 patients....

We have been following Syfovre drug safety developments having to do with retinal vascular occlusion and retinal vasculitis cases as well as other eye-related Syfovre side effects since July 2023. These are the five most recent articles we have written about Syfovre injections side effects:

1. Syfovre Safety-Benefit Assessment by Europe's Drug Regulator Differs From FDA (6/28/2024)
2. Syfovre Retinal Vaso-occlusive Vasculitis Case Report Involving 78-year Old Woman With Vision Loss (4/24/2024)
3. Syfovre Case Report: Occlusive Retinal Vasculitis Shortly After Patient's First Syfovre Injection (3/6/2024)
4. Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed (12/27/2023)
5. Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections (12/4/2023)

As stated at the beginning of this article, we are handling Syfovre injections side effects legal compensation cases being filed for patients as product liability personal injury lawsuits filed against the drug company Apellis. We have a free online Syfovre Case Evaluation for these Syfovre lawsuits, or you can call us toll-free at 800-426-9535.

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Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION

Nonarteritic Anterior Ischemic Optic Neuropathy (NAION), or "Eye Stroke", Can Cause Vision Loss

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Wegovy, Rybelsus, and Ozempic eye side effects are possible given the recent findings that the active ingredient of these three drugs semaglutide is associated with nonarteritic anterior ischemic optic neuropathy (NAION).

As background, NAION develops from insufficient blood flow to the optic nerve and causes sudden painless vision loss in one eye. It is the second most common cause of blindness due to optic nerve damage, after glaucoma.

We begin our reporting on the new semaglutide side effects findings with this July 3, 2024, STAT news article, "Study links Ozempic to higher risk of eye condition that can cause vision loss":

A new observational study on [July 3, 2024] reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision loss.

After hearing anecdotes of patients on the diabetes and obesity drugs experiencing nonarteritic anterior ischemic optic neuropathy, or NAION, researchers at Massachusetts Eye and Ear analyzed data from a registry of patients at their institution to see if there was a broad trend....

In both the diabetes and obesity cohorts that got semaglutide, the researchers found that NAION cases occurred most frequently in the first year after the medications were prescribed.

NAION, sometimes referred to as an “eye stroke,” occurs from a lack of sufficient blood flow to the optic nerve. It typically causes sudden vision loss and, in severe cases, can lead to blindness. There are currently no proven treatments for the condition.

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Ozempic / Wegovy / Rybelsus

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The medical journal article that presented the new semaglutide eye side effects findings, "Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide", was published on July 3, 2024, by JAMA Ophthalmology, and begins with this Key Points section:

• Question  Are prescriptions for semaglutide associated with an increased risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients with type 2 diabetes or patients who are overweight or obese?
• Findings  This matched cohort study of 16 827 patients revealed higher risk of NAION in patients prescribed semaglutide compared with patients prescribed non–glucagon-like peptide receptor agonist medications for diabetes or obesity.
• Meaning  The findings suggest a potential risk of NAION associated with prescriptions for semaglutide, but future study is required to assess causality.

A good summary of these Wegovy, Rybelsus, and Ozempic (semaglutide) eye side effects findings was provided in this July 3, 2024, MedPage Today article, "Semaglutide May Be Linked to Condition That Causes Blindness":

Over a mean follow-up of nearly 3 years, patients with diabetes on semaglutide had more than a fourfold higher risk for developing nonarteritic anterior ischemic optic neuropathy (NAION) compared with patients not on a GLP-1 agonist (HR 4.28, 95% CI 1.62-11.29, P<0.001), reported Joseph Rizzo III, MD, of Massachusetts Eye and Ear and Harvard Medical School in Boston, and colleagues.

Those prescribed semaglutide for overweight or obesity had an over sevenfold higher risk for NAION (HR 7.64, 95% CI 2.21-26.36, P<0.001), a significant cause of blindness, they wrote in JAMA Ophthalmology.

Over 3 years, the cumulative incidence of NAION were 8.9% and 6.7% in the two semaglutide groups, respectively, versus 1.8% and 0.8% for the non-GLP-1 groups.

"Despite evidence of neuroprotective properties, expression of the GLP-1 receptor in the human optic nerve and GLP-1 [receptor agonist] RA-induced enhanced sympathetic nervous system activity might influence optic nerve head perfusion and potentially increase the risk of NAION," suggested Rizzo and co-authors.

We are interested in hearing from patients who developed NAION following the use of Ozempic, Wegovy, or Rybelsus. We point out that NAION is sometimes referred to more simply as an “eye stroke" and, as it is a form of "optic neuropathy" (an eye disease category), NAION may be noted only as optic neuropathy in the medical records.

Patients who have been diagnosed with semaglutide-related NAION and experienced blindness or vision loss may be entitled to legal compensation by filing a drug injury lawsuit against Novo Nordisk, the pharmaceutical company responsible for Ozempic, Wegovy, and Rybelsus.

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Syfovre Safety-Benefit Assessment by Europe's Drug Regulator Differs From FDA

EMA’s CHMP Does Not Approve Syfovre for a Second Time, Citing "significant risk of adverse events"

 

(Posted by Tom Lamb at Drug Injury Watch)

 

There seems to be some disagreement about the Syfovre safety-benefit assessment when it comes to the US FDA and its European counterpart, the European Medicines Agency (EMA).

In late June 2024, Europe’s drug regulator, the Committee for Medicinal Products for Human Use (CHMP), did not approve Syfovre for a second time, with Apellis Pharmaceuticals asserting it will continue its efforts to market Syfovre in Europe.

From this Fierce Pharma June 28, 2024 article, "EU's drug regulator again rejects Apellis' eye med....", we get the latest on what is happening with Syfovre in Europe:

For the second time in six months, Europe’s Committee for Medicinal Products for Human Use (CHMP) has given a thumbs down to Apellis’ Syfovre for the treatment of patients with geographic atrophy (GA) caused by age-related macular degeneration.

In a release, Apellis noted that there were “multiple dissenting votes” by CHMP members to the opinion. The company added that it plans to seek a reexamination of the opinion, with a final decision expected in the fourth quarter of this year.

“Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients,” the CHMP said. “It was noted that benefits of a treatment should impact patients’ everyday functioning, and this was not demonstrated in the studies.”

“In terms of safety,” the CHMP continued, “regular injections into the eye carry a significant risk of adverse events, including the development of other forms of AMD or inflammation in the eye, that could further worsen vision.”

In January of this year, the CHMP adopted its first negative opinion on Syfovre. The drug was approved by the FDA in February of 2023 and generated $275 million in sales last year despite early reports of inflammation for some users.

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For more detail, we get this information from the updated Syfovre (pegcetacoplan) page on the EMA's website (accessed 6/28/24):

The European Medicines Agency has recommended the refusal of the marketing authorisation for Syfovre, a medicine intended for the treatment of geographic atrophy caused by age-related macular degeneration (AMD)....

The Agency issued its opinion on 27 June 2024....

What were the main reasons for refusing the marketing authorisation?

Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients. It was noted that benefits of a treatment should impact patients’ everyday functioning, and this was not demonstrated in the studies. In terms of safety, regular injections into the eye carry a significant risk of adverse events, including the development of other forms of AMD or inflammation in the eye, that could further worsen vision. Therefore, the Agency’s opinion was that a positive balance of benefits and risks of Syfovre in the treatment of geographic atrophy caused by AMD could not be established and it recommended refusing marketing authorisation.

As we have reported previously, Syfovre side effects include occlusive retinal vasculitis, which is a type of eye inflammation that blocks blood flow to the retina resulting in vision loss and potentially causing blindness. There have also been cases of non-occlusive retinal vasculitis and other types of eye inflammation.

We have been monitoring this Syfovre drug safety issue since July 2023 on Drug Injury Watch, and these are the four most recent articles:

• Syfovre Retinal Vaso-occlusive Vasculitis Case Report Involving 78-year Old Woman With Vision Loss (4/24/2024)
  
  
• Syfovre Case Report: Occlusive Retinal Vasculitis Shortly After Patient's First Syfovre Injection (3/6/2024)
  
  
• Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed (12/27/2023)
  
  
• Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections (12/4/2023)
  
  

We continue to investigate possible Syfovre drug injury lawsuits for patients who developed retinal vasculitis or retinal vascular occlusion with resulting vision loss or blindness after their Syfovre injection. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre -- not the patient's eye doctor.

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Syfovre Retinal Vaso-occlusive Vasculitis Case Report Involving 78-year Old Woman With Vision Loss

She Went to the Local ER With Loss of Vision 11 Days After Receiving an Intravitreal Syfovre (Pegcetacoplan) Injection

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In the March 2024 edition of the American Journal of Ophthalmology Case Reports medical journal, there is a Syfovre retinal vaso-occlusive vasculitis case report involving a 78-year old woman with vision loss that happened back in the first part of 2023. This article, "Retinal vasculitis following intravitreal pegcetacoplan administration", was initially submitted to that medical journal in July 2023 and first available online in January 2024.

From the Abstract for this relatively recent article about a Syfovre retinal vaso-occlusive vasculitis case:

Purpose: To describe a case of retinal vaso-occlusive vasculitis with associated lid edema and conjunctivitis following intravitreal [Syfovre (pegcetacoplan)] administration in a patient with geographic atrophy (GA).

Observation: A 78 year old Caucasian woman presented with complaints of lid edema, conjunctival injection, loss of vision, and mild ocular discomfort eleven days after receiving an intravitreal [Syfovre (pegcetacoplan)] injection in the left eye for geographic atrophy. Visual acuity on presentation was decreased to 20/400 from 20/200 previously in that eye....

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We get additional details about this Syfovre retinal vaso-occlusive vasculitis case from the full-text article:

• "We present a case of [Syfovre (pegcetacoplan)] associated vaso-occlusive vasculitis atypically presenting with associated lid edema and conjunctivitis, and subsequently developing hyphema and vitreous hemorrhage."
• "Eleven days after her [first Syfovre (pegcetacoplan) injection], the patient presented to the ER with left eyelid edema, ocular discomfort and conjunctival injection. She also complained of headache and loss of vision."
• "Two days after the ER visit (thirteen days after receiving the [Syfovre (pegcetacoplan)] injection), the patient came for ophthalmologic evaluation. Visual acuity had decreased to 20/400 in the left eye."
• "Differential diagnosis included central retinal vein occlusion. However, the patient had no risk factors for central retinal vein occlusion such as diabetes or hypertension."
• "Hemorrhagic occlusive retinal vasculitis (HORV) was also included in the differential diagnosis."
• "Like the [Beovu (brolucizumab)] and hemorrhagic occlusive retinal vasculitis cases, this presentation most likely represents a delayed hypersensitivity reaction.... Unlike most of the [Beovu (brolucizumab)] associated vasculitis, in our case, there had been no intraocular injections prior to the administration of [Syfovre (pegcetacoplan)] and there was only a minimal anterior chamber reaction upon presentation."

From the Conclusion part of that March 2024 medical journal article about this Syfovre retinal vaso-occlusive vasculitis case:

Being vigilant after the administration of intraocular pegcetacoplan and encouraging prompt evaluation of patients who present with new symptoms post injection is critical. Prompt treatment with topical, local, systemic corticosteroids is critical to control the inflammatory response to prevent further visual loss.

In connection with that last point, the November 2023 "Dear Doctor" letter about Syfovre from Apellis Pharmaceuticals, titled "SUBJECT: SYFOVRE® (pegcetacoplan injection), New Warnings and Precautions: Retinal Vasculitis and/or Retinal Vascular Occlusion", which had a "Prescriber Action" part.

We continue to investigate possible Syfovre drug injury lawsuits for patients who developed retinal vasculitis or retinal vascular occlusion with resulting vision loss or blindness after their Syfovre injection. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre -- not the patient's eye doctor.

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Syfovre Eye Injury Cases: More Questions Than Answers One Year After First Reports

Retinal Vasculitis After Syfovre Injections: Etiology is Still Unknown and Incidence Rate Remains Unclear

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Syfovre (pegcetacoplan) was approved by the FDA in February 2023 as an eye injection to treat geographic atrophy (GA), a relatively rare condition secondary to age-related macular degeneration. Beginning in April 2023, there have been reports of Syfovre eye injury cases, including (1) retinal vasculitis resulting in significant vision loss, and (2) intraocular inflammation without retinal vascular involvement.

Syfovre eye injury cases for patients with vision loss due to retinal vasculitis have received the most attention from retina specialists investigating this Syfovre drug safety issue. As of the beginning of April 2024, those retina specialists seem to agree that both the etiology and the incidence rate of retinal vasculitis after Syfovre injections remain uncertain.

Over time, Apellis Pharmaceuticals, the drug company responsible for Syfovre, has offered information about the number of Syfovre vials distributed for use and the percentage per Syfovre injection of patients who have developed vasculitis. In addition, Apellis has put out some possible explanations for these Syfovre eye injury cases involving vision loss.  Originally, Apellis speculated that certain needles used for Syfovre injections were the cause, but then some months later said a pre-existing allergy toward polyethylene glycol caused it.

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There are at least two difficulties when determining the number of Syfovre eye injury cases involving retinal vasculitis that have occurred to date.

First, it is generally acknowledged that voluntary reporting of prescription drug adverse events is inherently subject to underreporting. Therefore, it is likely that some Syfovre retinal vasculitis cases have not been reported to the FDA, Apellis, or retina specialists.

Second, some Syfovre patients who developed "mild" retinal vasculitis might not have been identified because they did not receive a careful dilated fundus examination or fluorescein angiography (FA). As such, these patients who might have developed retinal vasculitis are not counted by the Syfovre injections incidence rate.

We have been monitoring this Syfovre drug safety issue and continue to report significant developments on Drug Injury Watch. We list our three most recent articles if you want to learn more:

• Syfovre Case Report: Occlusive Retinal Vasculitis Shortly After Patient's First Syfovre Injection (3/6/2024)
• Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed (12/27/2023)
• Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections (12/4/2023)

We are investigating Syfovre eye injury cases for patients who suffered vision loss due to retinal vasculitis after receiving Syfovre injections. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, not the patients' ophthalmologists or retina specialists.

If we can assist you or someone you know, our Syfovre Case Evaluation Form is available online, or you can call us at (800) 426-9535 to speak about a possible Syfovre eye injury case.

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Syfovre Case Report: Occlusive Retinal Vasculitis Shortly After Patient's First Syfovre Injection

Pre-Existing Allergy Toward Polyethylene Glycol (PEG) is Most Recent Causation Theory Offered by Apellis

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In late January 2024, a leading medical journal for ophthalmologists and retina specialists, the Journal of VitreoRetinal Diseases, published this Syfovre case report, "Occlusive Retinal Vasculitis After a Single Injection of Pegcetacoplan", written by three authors affiliated with the Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, in Miami, Florida.

Here is the Abstract for this Syfovre case report involving an 80-year-old woman who developed retinal vasculitis shortly after just one Syfovre (pegcetacoplan) injection:

Purpose: To describe a patient with retinal vasculitis after a single intravitreal injection (IVI) of [Syfovre (pegcetacoplan)].

Methods: A case and its findings were analyzed.

Results: An 80-year-old woman was treated with [Syfovre (pegcetacoplan)] for subfoveal geographic atrophy. Ten days later, the patient noted “purple iridescent waves” but did not immediately report it. On day 18, she presented with pain and decreased visual acuity from 20/80 (pinhole) preinjection to 20/150 postinjection. No signs of inflammation were observed, and she was treated for high intraocular pressure (30 mm Hg). On day 23, iritis was noted. The fluorescein angiogram showed severe occlusive vasculitis involving all quadrants and the macula. The vasculitis/neuroretinitis laboratory panels were negative, and no contributing systemic features were identified other than well-controlled diabetes.

Conclusions: In this patient, occlusive retinal vasculitis occurred shortly after a single IVI of [Syfovre (pegcetacoplan)].

About a month earlier, the Journal of VitreoRetinal Diseases (JVRD), which is the peer-reviewed journal of the American Society of Retina Specialists (ASRS), published a more general report on numerous Syfovre cases of retinal vasculitis, co-authored by members of the ASRS Research and Safety in Therapeutics (ReST) Committee. In summary, this report considered 14 eyes of 13 patients who developed retinal vasculitis after their first Syfovre injection. For this set of Syfovre case reports, the ASRS ReST report provided these findings:

• 11 eyes were diagnosed as having developed occlusive vasculitis after a Syfovre injection;
• 6 of 14 eyes had significant vision loss, having lost more than 6 lines of vision; and,
• 2 eyes required enucleation, a surgical procedure that involves the removal of the entire eye.

And from the Abstract for that December 2023 JVRD article, "Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee":

Conclusions: There is currently no known etiology for vasculitis in this series. Optimum treatment strategies remain unknown. Infectious etiologies should be considered, and corticosteroid treatments may hasten resolution of inflammatory findings. Continued treatment of affected patients with [Syfovre (pegcetacoplan)] should be avoided.

A relatively minor correction, or "Corrigendum", was later issued to the ASRS Research and Safety in Therapeutics (ReST) Committee report, in February 2024, which read as follows:

The original sentence appeared as follows:

However, it is notable that [Syfovre (pegcetacoplan)] (and [Izervay (avacincaptad pegol)]) are synthetic PEGylated peptides and not biologically manufactured compounds.

The revised sentence now appears in the article as follows:

However, it is notable that [Syfovre (pegcetacoplan)] is a synthetic PEGylated peptide and not a biologically manufactured compound.

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Whether related or not, we use that February 2024 JVRD ASRS ReST report article correction as our transition to pointing out the most recent explanation from Apellis Pharmaceuticals about the cause of Syfovre patients developing vasculitis.

Before we get there, however, we want to present this contextual information from a Wikipedia page about PEGylation in a pharmaceutical context:

PEGylation (or pegylation) is the process of both covalent and non-covalent attachment or amalgamation of polyethylene glycol (PEG, in pharmacy called macrogol) polymer chains to molecules and macrostructures, such as a drug, therapeutic protein or vesicle, which is then described as PEGylated. PEGylation affects the resulting derivatives or aggregates interactions, which typically slows down their coalescence and degradation as well as elimination in vivo. [Footnotes omitted.]

Now, from this February 28, 2024, Fierce Pharma news report, "Apellis cites current challenges with Syfovre launch but bright prospects in the long term", we get the most recent explanation from Apellis about the cause of Syfovre-related vasculitis:

As for Syfovre’s safety issue — which Apellis originally speculated was a needle problem for the injected drug — the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said. [Emphasis added.]

Regarding the previous "causation" theory offered up by Apellis for a Syfovre case report involving retinal vasculitis, we take you back to this October 2023 article, "Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further 'Explanation' -- On That Aspect, in August 2023 Apellis Asked Doctors to Stop Using Syfovre Injection Kits With a 19-gauge Filter Needle".

Perhaps you know about a Syfovre case report and want to share your information. If so, we are most interested to hear from you and learn more about this (apparently) still-evolving Syfovre safety issue.

We are handling Syfovre drug injury lawsuits for patients who suffered vision loss due to vasculitis or vascular occlusion after a Syfovre injection. Those Syfovre lawsuits would be filed against Apellis Pharmaceuticals, not the patients' ophthalmologists or retina specialists.

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