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Law Offices of Thomas J. Lamb

Syfovre Legal Compensation Cases for Retinal Vasculitis

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Syfovre legal compensation cases for retinal vasculitis diagnosed after a patient’s first Syfovre injection are being filed as drug injury lawsuits. The basis for these product liability Syfovre lawsuits is the drug company Apellis Pharmaceuticals failed to warn about retinal vasculitis as a side effect until it revised the Syfovre drug label in November 2023.

The FDA approved Syfovre (pegcetacoplan) as an eye injection treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in February 2023.

The American Society of Retina Specialists (ASRS), published a general report on Syfovre retinal-related vision loss, co-authored by the ASRS Research and Safety in Therapeutics (ReST) Committee in December 2023. Their report revealed that at least 13 patients had developed Syfovre retinal-related vision loss earlier in 2023. Specifically, those 13 patients developed retinal vasculitis after their first Syfovre injection.

As mentioned previously, while Syfovre was initially available for use in February 2023, it was not until November 2023 that Apellis added new Syfovre warnings for retinal vascular occlusion and retinal vasculitis cases associated with Syfovre injections to the Syfovre drug label.  This time-lapse is a central part of the Syfovre legal compensation cases that are being filed.

In more detail, Syfovre injection side effects include occlusive retinal vasculitis and non-occlusive retinal vasculitis. These types of eye inflammation result in vision loss and potentially cause blindness.

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“, we get the most recent findings about patients who were treated with Syfovre and then diagnosed with retinal vasculitis: “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 are handling Syfovre legal compensation cases for retinal vasculitis diagnosed after a patient’s first Syfovre injection. These personal injury cases are drug injury lawsuits filed against Apellis Pharmaceuticals. More precisely, these Syfovre lawsuits are based on product liability law for the alleged failure to warn about retinal vasculitis as a Syfovre side effect promptly. As such, these Syfovre lawsuits are not filed against the patients’ eye doctors.

We have a free online Case Evaluation for these Syfovre legal compensation cases, or you can call us toll-free at 800-426-9535.

[Read the article in full at source]

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Syfovre’s Risks Keep It Off The Market In Europe, Again, With June 2024 Decision

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As we have been reporting since July 2023, Syfovre’s risks include serious eye side effects such as occlusive retinal vasculitis, 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.

In late June 2024, Europe’s drug regulator did not approve Syfovre for a second time, meaning that Syfovre is still unavailable in Europe. In the US, Syfovre was approved by the FDA in February 2023.

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….

“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….

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

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.

[Read the article in full at source]

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Syfovre: Loss of Vision 11 Days After Receiving Syfovre Injection

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This blog post is about a Syfovre loss of vision case involving a 78-year-old woman with vision loss in the first part of 2023. It was reported in this medical journal article, “Retinal vasculitis following intravitreal pegcetacoplan administration”, which appeared in the March 2024 edition of the American Journal of Ophthalmology Case Reports.

From the Abstract for this relatively recent article about a Syfovre loss of vision 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….

From the Conclusion part of that March 2024 medical journal article about this Syfovre loss of vision 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.

We are handling Syfovre drug injury lawsuits for people who developed retinal vasculitis or retinal vascular occlusion causing loss of vision or blindness after their Syfovre injection. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre — not the person’s eye doctor.

Perhaps you know a person who has had a loss of vision after getting a Syfovre injection in their eye. In that situation, this person must contact a lawyer to handle their Syfovre case to get legal compensation for the Syfovre drug injury they have suffered. Syfovre loss of vision lawsuits are being filed as individual cases. There will not be any Syfovre class actions for people who have experienced any loss of vision due to Syfovre.

[Read article in full at original source]

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At Least 13 Patients Had Syfovre Retinal-Related Vision Loss in 2023

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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. In summary, 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 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:

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.

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 retinal-related vision loss:

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.

We are handling Syfovre drug injury lawsuits for patients who had Syfovre retinal-related vision loss. Those Syfovre lawsuits would be filed against Apellis Pharmaceuticals, not the patients’ ophthalmologists or retina specialists.

[Read article in full at original source]

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New Syfovre Warnings for Retinal Vascular Occlusion and Retinal Vasculitis

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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 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 by Apellis Pharmaceuticals.

Just a few months ago, in August 2023, Apellis suggested that an issue related to certain injection kits used for Syfovre may be a possible cause of the retinal vascular occlusion and retinal vasculitis cases associated with Syfovre use. And back then Apellis had urged doctors to switch to a different injection kit.

We have been writing about 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. Here is a list of our earlier Drug Injury Watch articles:

Syfovre Patients Eye Side Effects Cases at Iowa Clinic: Important 2023 AAO Meeting Presentation  [11/10/2023]

Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further “Explanation”  [10/13/2023]

Syfovre Adverse Reaction Cases: Updated Number of Patients With Retinal Vasculitis, Timeline of Events  [8/17/2023]

Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists  [7/28/2023]

Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness [7/19/2023]

We are investigating Syfovre drug injury lawsuits that would be filed against Apellis Pharmaceuticals for patients involving retinal vascular occlusion and retinal vasculitis cases as well as other eye-related Syfovre side effects.

[Read article in full at original source]

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Syfovre Retinal Vasculitis Cases Caused by Injection Kits With a 19-gauge Filter Needle?

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In what seems to be the latest Syfovre safety update, in early October 2023 Apellis reported an increase in the number of Syfovre retinal vasculitis cases, but Apellis did not provide any significant new information regarding an “explanation” as to how these Syfovre adverse reaction events happened.

EndPoints News Senior Editor Amber Tong, in her August 23, 2023 article “Apellis’ safety probe into eye drug unearths issues with injection kits, while side effects remain ‘very rare'”, summarized the earlier August 2023 Apellis Syfovre safety update as follows:

Apellis has found a possible culprit for the safety events affecting a small number of patients who received its geographic atrophy treatment — and the injection kit, not the drug itself, may be to blame.

Following a comprehensive investigation, Apellis said it identified “internal structural variations” in the 19-gauge filter needle that’s used in some of its injection kits for Syfovre (pegcetacoplan). It did not find a causal relationship between those structural variations and the cases of retinal vasculitis reported during real-world use of Syfovre. But it is advising healthcare practitioners to stop using kits with the 19-gauge filter needle and switch to using those with the 18-gauge filter needle, which is used to withdraw the drug solution from the vial….

The update amounts to “the closest thing to an explanation,” wrote Stifel analyst Annabel Samimy in a note.

On October 5, 2023, Apellis Pharmaceuticals issued an update for its Syfovre investigation into retinal vasculitis cases involving patients who used Syfovre for geographic atrophy (GA). From one part of this company press release, “Apellis Announces Preliminary U.S. Net Revenues of Approximately $74 Million for SYFOVRE® (pegcetacoplan injection) in the Third Quarter of 2023”, we get the latest number of Syfovre-associated retinal vasculitis cases:

  • In total, there have been 10 confirmed events of retinal vasculitis (seven occlusive, three non-occlusive) and two suspected events.
  • Since the last update on August 22, there was one new confirmed event that occurred in early August and two new suspected events, one that occurred in mid-August and one in September. Of the two events that were previously classified as suspected, one event has been confirmed and the other was adjudicated to not be retinal vasculitis.

In summary, there is an increase in the number of Syfovre retinal vasculitis cases, but we do not have any further “explanation” about how or why these Syfovre retinal vasculitis adverse reaction events happened.

[Read article in full at original source]

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Syfovre Eye Injections Adverse Reactions Update August 2023

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We have some new information about Syfovre eye injections adverse reactions causing vision loss and blindness from Apellis Pharmaceuticals and the American Society of Retina Specialists (ASRS).

Apellis said that it has confirmed seven cases of Syfovre eye injections adverse reactions. More specifically, these Syfovre vision loss cases involve a type of eye inflammation called retinal vasculitis. Four Syfovre patients have developed occlusive retinal vasculitis, a possibly blinding condition in which blood flow to the retina is blocked.

The ASRS shared a timeline of events related to these cases of Syfovre eye injections adverse reactions, as outlined below:

  • July 3, 2023: The first report of panuveitis with retinal occlusive vasculitis was received by the ASRS Research and Safety in Therapeutics (ReST) Committee.
  • July 5, 2023: ReST contacted Apellis to discuss safety concerns arising from this first Syfovre vision loss case.
  • July 6-12, 2023: The ASRS received six additional reports of Syfovre eye injections adverse reactions in patients.
  • July 12, 2023: Apellis and the ASRS Research and Safety in Therapeutics (ReST) Committee met to discuss severe intraocular inflammation and cases of vasculitis in patients who had received Syfovre eye injections.
  • July 15, 2023: The ASRS Executive Committee unanimously approved the Syfovre safety concerns “communication”, which was agreed to by Apellis and sent to ASRS members that same day.

It has been reported by medical news sources that as of late July 2023, Apellis does not know the cause, yet, for these seven cases of Syfovre eye injections adverse reactions. Further, Apellis has said that so far the company has only been able to rule out drug product quality and manufacturing issues.

As such, other possible causes for these Syfovre vision loss cases involving retinal vasculitis remain to be researched.

We are investigating Syfovre vision loss cases as drug injury lawsuits against Apellis for patients who developed occlusive retinal vasculitis or eye inflammation after receiving a Syfovre eye injection.

[Read article in full at original source]

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Syfovre Vision Loss Cases Reported In Patients After Their First Injection

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Syfovre vision loss cases have been reported by patients after the first time they used this injection treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

In mid-July 2023 the American Society of Retinal Specialists (ASRS) issued a warning letter about Syfovre being associated with vision loss as well as some eye-related severe adverse reactions.

This still-developing Syfovre safety issue was next addressed by a so-called “Dear Doctor” letter that was sent to ophthalmologists by Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, later in July 2023, after the ASRS letter.

From this July 28, 2023 item, “First-to-Market Edge for Apellis’s Syfovre in Geographic Atrophy Diminished in the Face of an Unexpected Safety Signal”, we get the following information:

According to the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee, ophthalmologists have reported cases of intraocular inflammation (IOI) following the administration of Syfovre. In addition to mild-moderate IOI, these reports also include severe IOI, retinal vasculitis, and occlusive retina vasculitis (six cases at the time of writing). These events occurred between 7 and 13 days after the initial dose of Syfovre was administered.

We are investigating Syfovre vision loss cases that would be filed as drug injury lawsuits against Apellis for patients who developed occlusive retinal vasculitis or eye inflammation after receiving a Syfovre injection.

We will continue to monitor this Syfovre safety issue and report significant developments.

[Read article in full at original source]

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Syfovre Occlusive Retinal Vasculitis Cases Warning Letter July 2023

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The American Society of Retinal Specialists (ASRS) issued a warning letter about the Syfovre occlusive retinal vasculitis cases in patients who used this injection eye drug. Syfovre is a 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.

This ASRS July 2023 letter about Syfovre occlusive retinal vasculitis cases pointed out that the vision loss symptoms began one to two weeks after a patient’s first Syfovre (pegcetacoplan) injection. The ASRS said there have been six reports of occlusive retinal vasculitis to date, as well as other reports of serious eye inflammation due to Syfovre injections.

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 couple of years, our law firm handled Beovu lawsuits for vision loss, blindness, and other serious eye problems that were filed against Novartis, the manufacturer of Beovu.

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.

If you or someone you know has a possible Syfovre drug injury lawsuit, we encourage you to submit a Case Evaluation Form online.

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Beovu Label Change: Novartis Adds Information, Increases Safety Warnings in February 2022

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We had been watching for a second Beovu label change since May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, and, at the same time, said it would update the Beovu drug label. Finally, in February 2022, Novartis added information and increased safety warnings about various Beovu side effects, such as retinal vasculitis, retinal vascular occlusion, and retinal artery occlusion.  The first Beovu label change happened back in June 2020.

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, and to be able to compare the Beovu Prescribing Information “Revised: 2/2022” document with the earlier “Revised: 6/2020” version, we direct you to this FDA webpage “Drug Safety-related Labeling Changes (SrLC) for Beovu (brolucizumab-dbll)“.

There you will see the extent of revisions made to the three parts that are  identified in the “Recent Major Changes” section of the new 2022 Beovu drug label:

  • 5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion
  • 6.1 Clinical Trials Experience
  • 6.2 Immunogenicity

As background, Beovu 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, and we will continue to watch 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.  As mentioned at the outset, there was a first Beovu label change in June 2020 and, now, a second Beovu label change in February 2022.

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.

[Read article in full at original source]

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