Drug Injury Watch

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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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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Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections

November 2023 Syfovre Label Change Comes After Earlier Reports of Eye Inflammation and Severe Vision Loss

 

(Posted by Tom Lamb at Drug Injury Watch)

---

UPDATE: 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 Pharmaceuticals about the cause of Syfovre eye-related side effects:

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.]

(2/28/24)

---

We have been writing about Syfovre drug safety developments having to do with retinal vasculitis cases and other eye-related side effects since July 2023. This latest article is about the November 2023 Syfovre label change that adds new warnings about retinal vasculitis and/or retinal vascular occlusion associated with Syfovre injections.

For background, here is a general Syfovre timeline bringing us up to the present time:

• Syfovre (pegcetacoplan injection) was approved by the FDA in February 2023 as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD);
• In July 2023 the first reports of retinal vasculitis associated with Syfovre became public. In turn, Apellis Pharmaceuticals launched an investigation for retinal vasculitis cases and other eye-related side effects; and,
• Then Apellis suggested in August 2023 that an issue related to certain injection kits used for Syfovre may be a possible cause of eye inflammation sometimes leading to retinal vasculitis and severe vision loss, Apellis urging doctors to switch to a different injection kit.

With this November 2023 Syfovre label change it now seems that the retinal vasculitis cases associated with Syfovre use are due to the drug itself and not the injection kits, as had been suggested by Apellis.

The two newly added subsections to the Syfovre Prescribing Information document "Revised: 11/2023" version (accessed 12/4/23) with warnings about retinal vasculitis are set forth below:

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE [see Adverse Reactions (6.2)]. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay.

6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of SYFOVRE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders: retinal vasculitis with or without retinal vascular occlusion.

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Here is a list of our earlier Drug Injury Watch articles about Syfovre drug safety developments having to do with retinal vasculitis cases and other eye-related side effects:

Syfovre Patients Eye Side Effects Cases at Iowa Clinic: Important 2023 AAO Meeting Presentation -- A Syfovre Case of Hemorrhagic Occlusive Vasculitis-type Inflammation With Continued Blindness Is Reported [11/10/2023]

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 [10/13/2023]

Syfovre Adverse Reaction Cases: Updated Number of Patients With Retinal Vasculitis, Timeline of Events -- Additional Information from Apellis and the American Society of Retina Specialists About Ongoing Syfovre Safety Issues  [8/17/2023]

Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists -- A July 2023 "Dear Doctor" Letter From Apellis Acknowledges This Developing Syfovre Safety Signal Situation  [7/28/2023]

Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness -- American Society of Retinal Specialists (ASRS) July 2023 Warning Letter About Adverse Events Reports Associated With Syfovre  [7/19/2023]

We are investigating Syfovre drug injury lawsuits for patients who developed retinal vasculitis, eye inflammation, severe vision loss, or blindness after receiving their Syfovre injection.  To be clear, these lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre -- not the patient's eye doctor.

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Syfovre Patients Eye Side Effects Cases at Iowa Clinic: Important 2023 AAO Meeting Presentation

A Syfovre Case of Hemorrhagic Occlusive Vasculitis-type Inflammation With Continued Blindness Is Reported

 

(Posted by Tom Lamb at Drug Injury Watch)

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UPDATE: 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 Pharmaceuticals about the cause of Syfovre eye-related side effects:

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.]

(2/28/24)

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At the 2023 Annual Meeting of the American Academy of Ophthalmology (AAO), various Syfovre patients eye side effects cases were discussed by William J. Johnson, M.D., of the Wolfe Clinic in Iowa. These Syfovre side effects cases range from hemorrhagic occlusive vasculitis-type inflammation with continued blindness to uveitis to vision loss to symptomatic floaters.

From this November 3, 2023 news report, "Details on 5 Cases of Complications From Syfovre Injections | AAO 2023", by Peter Wehrwein, Managing Editor of Managed Healthcare Executive, we get the following information about this significant Syfovre 2023 AAO Meeting presentation:

One of the patients experienced hemorrhagic occlusive vasculitis-type inflammation and continues to have no light perception — clinical terminology for blindness — in the treated eye, reported William J. Johnson, M.D., a retinal fellow at the Wolfe Clinic, which has 24 locations in Iowa.

Johnson... said Wolfe Clinic retina specialists administered 129 injections of Syfovre in 96 eyes of 84 patients between March 2023 and mid-July, when it paused used of Syfovre injections because of the complications.

Here are some of the details about the five cases Johnson presented at the AAO meeting. He provided a few more details in a subsequent phone conversation:

• An 80-year-old male who developed silicone oil droplet complications experienced symptomatic floaters. There was no objective change in vision or inflammation, but the patient decided not to have any further treatments....
• A 72-year old woman developed intermediate and anterior (front of the eye) uveitis following her first injection with Syfovre. Her vision returned to its baseline level after intensive topical steroid treatment.
• An 86-year-old woman developed uveitis after her second Syfovre injection. Her condition improved initially with steroid drops but then worsened. She was treated with antibiotic and steroid injections in the eye but did not improve. After more intense steroid treatment was started, her vision slowly improved over 10 weeks and returned to being just below baseline. Johnson said there was some debate about how this case should be classified, with Wolfe specialists seeing some findings as evidence pointing to pre-existing branch retinal vein occlusion but others seeing them as evidence of hemorrhagic vasculitis without occlusion.
• A 72-year-old female presented with vision loss seven weeks after a Syfovre injection. The person’s vision improved after three monthly treatments with Vabysmo (faricimab), an anti-vascular endothelial growth factor (VEGF) used to treat neovascular, or “wet,” age-related macular degeneration (AMD). She had converted from dry to wet AMD, and Johnson said such cases were seen in clinical trials of Syfovre and are a known complication. Her vision improved with the Vabysmo treatments but never fully recovered and remained below her baseline level.

The fifth case was the patient who experience no light perception in his treated eye. Johnson said he was a 96-year-old man who presented nine days after his first injection with decreased vision, pain, elevated pressure in the eye, and vasculitis. He was initially treated with antibiotics, steroids and topical eye hypertensives. That treatment was followed by stronger steroids and then by anti-VEGF therapy. Johnson said the baseline vision of the treated eye was 20/60.

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Suber S. Huang, M.D., MBA, said this Syfovre patients eye side effects cases presentation was one of the most important of this 2023 AAO Annual Meeting in San Francisco in early November. Notably, it was the first major AAO meeting since the FDA approved Syfovre in February 2023 to treat geographic atrophy (GA).

On November 4, 2023, Managed Healthcare Executive made available online a brief interview (2:49 video) with Dr. Huang on a page titled "Syfovre Complications Discussed in Late-Breakers Session | AAO 2023".

We have been following this still-developing drug safety issue involving Syfovre patients eye side effects cases since July 2023. Our most recent article, "Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further 'Explanation'", was posted last month, in mid-October 2023.

At present, we are investigating Syfovre drug injury lawsuits against Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, for patients who developed occlusive retinal vasculitis, eye inflammation, vision loss, or blindness after receiving Syfovre injections.

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Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness

American Society of Retinal Specialists (ASRS) July 2023 Warning Letter About Adverse Events Reports Associated With Syfovre

 

(Posted by Tom Lamb at Drug Injury Watch)

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UPDATE: 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 Pharmaceuticals about the cause of Syfovre eye-related side effects:

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.]

(2/28/24)

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On July 15, 2023, the American Society of Retinal Specialists (ASRS) issued this letter to its members, "ASRS Research and Safety in Therapeutics (REST) Committee Update on Adverse Events Reports Associated with Syfovre", warning about the Syfovre side effects eye inflammation and occlusive retinal vasculitis in patients who used this injection treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Occlusive retinal vasculitis is a type of eye inflammation that blocks blood flow to the retina resulting in vision loss and could potentially cause blindness.

The ASRS July 2023 letter about these Syfovre side effects pointed out reported cases of eye inflammation and six reports of occlusive retinal vasculitis, noting that these vision problems began one to two weeks after a patient’s first Syfovre (pegcetacoplan) injection.

From this news report, "Apellis rocked by retinal vasculitis reports linked to Syfovre", published in the July 18, 2023 edition of ThePharmaLetter, we get these details about this new and still evolving Syfovre side effects situation:

According to Apellis, the company has reviewed the retinal vasculitis events with the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics Committee.

All the events were observed after the first injection of Syfovre, between seven to 13 days after drug administration, and with no specific lots implicated.

Upon review with external experts, two of the events were confirmed as occlusive, one was confirmed as non-occlusive, and the remaining three were undetermined based on limited information and lack of imaging. The cause of these events is unclear, and outcomes in these patients are still evolving....

In a filing to the US Securities and Exchange Commission, Apellis explained: “The reported vasculitis events have occurred at an estimated rate of approximately 1 in 10,000 injections, or 0.01% per injection. To date, approximately 60,000 vials of Syfovre have been distributed since the FDA approval on February 17, 2023, including commercial vials shipped to physician practices as well as sample vials delivered. In addition, there were zero events of retinal vasculitis reported in the clinical trials, reflecting more than 23,000 injections to date.”

Following the review with the FDA, no action is currently planned, but Apellis is continuing to conduct a thorough investigation of the events alongside the ReST Committee and several external specialists.

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Back in 2020, the ASRS alerted its member doctors about 14 cases of retinal vasculitis in patients after using Beovu, soon after that wet age-related macular degeneration drug from Novartis was approved by the FDA.

During the past few years, our law firm has handled Beovu lawsuits that involved retinal vasculitis causing vision loss and blindness.  Those Beovu cases were filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to adequately warn doctors and patients about these Beovu side effects in a timely manner. We point out that the first three Beovu vision loss lawsuits filed in the US were for clients of our law firm.

Currently, we are investigating Syfovre drug injury lawsuits against Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, for patients who have been diagnosed with retinal vasculitis or some other type of eye inflammation after receiving a Syfovre injection, causing vision loss or blindness.

If you or someone you know has a possible Syfovre drug injury lawsuit, we encourage you to submit a Syfovre Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb. Either way, you will get Mr. Lamb’s impressions about your Syfovre side effects case based on his more than 20 years of experience handling drug injury lawsuits.

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Novartis Finally Issues Revised Beovu Prescribing Information for US in February 2022

Meaning as Regards Beovu Safety Issues by a Comparison of Major Changes Made: "Revised: 2/2022" vs. "Revised: 6/2020"

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Beovu (brolucizumab) was approved by the FDA in 2019 as a treatment for neovascular (wet) age-related macular degeneration (AMD). Since then, there have been reported cases of Beovu eye-related side effects such as retinal vasculitis, retinal vascular occlusion, or retinal artery occlusion leading to vision loss. We have followed these Beovu safety issues for the past two years here on Drug Injury Watch, with our first article dating back to February 2020 (see: "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug").

Most recently we have been watching for a forecasted Beovu label change which would, presumably, add new and updated warnings about Beovu eye-related side effects. Now, in February 2022, there is finally a revised Beovu drug label here in the US.

We use the word "finally" because it was back in May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, that Novartis first said it would update the Beovu drug label (see: "Beovu Vision Loss Side Effects Continue to Plague Novartis, Ending 3 Key Clinical Trials in May 2021").  Further, over in Europe, Novartis sent out a November 2021 “Dear Doctor” Letter about Beovu, which was followed by an MHRA January 2022 Drug Safety Update item for Beovu that stated:

New information on [the Beovu adverse events retinal vasculitis and retinal vascular occlusion], including risk factors and possible mechanism, was considered in a recent European safety review and ophthalmologists were informed of the new recommendations in a letter in November 2021. The product information of [Beovu (brolucizumab)] will also be updated to reflect this information.

You can learn more about this first Beovu drug label change made after what Novartis did and said back in May 2021 by taking a look at this recent Drug Injury Watch article, "Beovu Drug Label Change in December 2021 Adds More Information About Vision Loss Side Effects".

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So that people can draw their own conclusions about what this February 2022 Beovu label change means as regards the lingering Beovu safety issues mentioned at the outset, we will present a comparison of the Beovu Prescribing Information "Revised: 2/2022" document  (PDF) with the earlier "Revised: 6/2020" version, limited to those three parts identified in the "Recent Major Changes" section of the new 2022 Beovu drug label.

 

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CHANGE (February 2022) -- 5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU. These immune mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events. Patients treated with BEOVU who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored [see Contraindications (4.2) and Adverse Reactions (6.1, 6.2)]. Patients should be instructed to report any change in vision without delay.

 

COMPARE (June 2020) -- 5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU [see Contraindications (4.2) and Adverse Reactions (6.1)]. Patients should be instructed to report any change in vision without delay.

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ADDED (February 2022) -- 6.1 Clinical Trials Experience (as a final paragraph, below Table 1)

In a clinical study (MERLIN), patients with nAMD who received BEOVU every 4-week maintenance dosing experienced a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion than patients who received BEOVU every 8 or 12-week maintenance dosing in the clinical studies (HAWK and HARRIER). The interval between two BEOVU doses during maintenance treatment should not be less than 8 weeks.

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CHANGE (February 2022) -- 6.2 Immunogenicity (final two paragraphs)

Anti-brolucizumab antibodies were detected in the pre-treatment sample of 36% to 52% of treatment naive patients. After initiation of dosing, anti-brolucizumab antibodies were detected in at least one serum sample in 53% to 67% of patients treated with BEOVU. Intraocular inflammation was observed in 6% of patients with anti-brolucizumab antibodies detected during dosing with BEOVU. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, are immune mediated adverse events related to exposure to BEOVU. This treatment emergent antibody response may develop following the first intravitreal injection.

Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy.

 

COMPARE (June 2020) -- 6.2 Immunogenicity (final two paragraphs)

Anti-brolucizumab antibodies were detected in the pre-treatment sample of 36% to 52% of treatment naive patients. After initiation of dosing, anti-brolucizumab antibodies were detected in at least one serum sample in 53% to 67% of patients treated with BEOVU. Intraocular inflammation was observed in 6% of patients with anti-brolucizumab antibodies detected during dosing with BEOVU.

The significance of anti-brolucizumab antibodies on the clinical effectiveness and safety of BEOVU is not known.

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We will continue to monitor the drug safety regulatory sector for further developments concerning Beovu eye-related side effects such as retinal vasculitis, retinal vascular occlusion, and retinal artery occlusion.

As we have reported previously, starting in January 2021, Beovu lawsuits have been filed for patients alleging that Novartis failed to warn doctors and patients about these Beovu vision loss side effects in a timely manner.

We continue to investigate Beovu drug injury lawsuits against Novartis where there has been vision loss due to retinal vasculitis, retinal vascular occlusion, or retinal artery occlusion after patients received their Beovu injections.

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