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Retinal vasculitis and retinal vascular occlusion are complex medical conditions. Both involve inflammation of the blood vessels in the retina. Both can result from receiving Syfovre intravitreal injections in treating geographic atrophy (GA). Both conditions can have serious implications. They can lead to vision loss, making early diagnosis and treatment crucial.
Patients are suing Syfovre makers for injuries from Syfovre injection treatments. Our lawyers are investigating cases of retinal vasculitis and retinal vascular occlusion in people who have received treatment injections with Syfovre.
If you or a loved one developed retinal vasculitis or retinal vascular occlusion after receiving Syfovre injections treatment for geographic atrophy, please contact our office today for a free case review at (800) 277-1193 or complete the Case Evaluation Form at the bottom of this page.
Our Syfovre lawyers strive to keep those affected by Syfovre injections informed of news and developments about the drug and related lawsuits.
September 2024 News Updates
European drug regulators have rejected Apellis Pharmaceuticals’ eye drug, despite multiple efforts by the company to have the decision reviewed. Apellis announced that a committee advising the European Medicines Agency confirmed its earlier decision from June to reject the application for pegcetacoplan, known as Syfovre in the U.S., which treats geographic atrophy. This ruling blocks Syfovre from being sold in Europe, where around 2.5 million people are affected by the disease. [Biopharma Dive]
July 2024 News Updates
A July 19, 2024, a news article titled “The Syfovre Balancing Act: The Retinal Vasculitis Risk Is Real But Research Also Points to Benefits | ASRS 2024” shared the latest findings on patients treated with Syfovre who later developed retinal vasculitis. According to two real-world evidence studies presented at the annual American Society of Retina Specialists (ASRS), the risk of developing retinal vasculitis is estimated to be around 1 in every 1,330 patients.
The company behind Syfovre has requested a re-examination of the European Medicines Agency’s (EMA) June 2024 decision to refuse marketing authorization for the drug. Syfovre is intended to treat geographic atrophy caused by age-related macular degeneration (AMD). Upon reviewing the grounds for the request, the EMA will re-evaluate its opinion and issue a final recommendation. [Source: European Medicines Agency]
Several recalls and regulatory actions for Syfovre injections explain how these lawsuits came about.
February 17, 2023: The FDA approved Syfovre (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
August 22, 2023: Apellis Pharmaceuticals, the makers of Syfovre, submitted a Prior-Approval Supplement (PAS) to add a warning about retinal vasculitis and/or retinal vascular occlusion.
November 30, 2023: the FDA approved the revised label. The updated label includes a section titled “Retinal Vasculitis and/or Retinal Vascular Occlusion,” warning that the use of Syfovre has been associated with adverse events, such as cases of retinal vasculitis and/or retinal vascular occlusion, often accompanied by intraocular inflammation. An event of retinal vasculitis or retinal vascular occlusion may occur with the first dose of Syfovre and can result in severe vision loss.
The label instructs healthcare providers to discontinue Syfovre treatment if patients develop these adverse reactions and advised patients to promptly report any changes in their vision.
On August 22, 2023, Apellis initiated a Class 2 Device Recall on their Injection Kits. This was the same day the company submitted the Post-Approval Supplement (PAS). According to the FDA, non-preferred characteristics in some kits’ 19-gauge x 1″ inch filter needles prompted the recall.
Apellis recommended that healthcare practitioners stop using injection kits containing the affected needle and dispose of the medical devices.
Instead, the company suggested using the injection kits containing the 18-gauge filter needle already in distribution.
In nylon mesh variations, the 19-gauge x 1″ filter needles in the Syfovre kits have issues with the nylon mesh. For example, filters were packed too tightly, filter material was exposed, and/or filter seams were weak. These problems could accidentally let small particles from the device get into the eye.
According to the U.S. Food and Drug Administration (FDA), doctors use of Syfovre to treat geographic atrophy (GA) caused by age-related macular degeneration (AMD). Another name for the drug is pegcetacoplan.
The drug is a complement inhibitor. The drug functions by connecting with specific proteins in the immune system known as complement proteins. This connection stops the immune system from causing inflammation and harming the retina in the eyes. This means it helps slow the growth of GA lesions and helps preserve vision by reducing significant vision loss and blindness.
Doctors administer the medication through a monthly injection using the Altaviz Needle Kit. The injection places the medication directly into the vitreous cavity (the space in the back of the eye).
According to the drug’s manufacturers, Syfovre slows the worsening of GA. However, Syfovre is not a cure for dry AMD and cannot reverse the damage already caused by GA.
Retinal vasculitis is a specific type of retinal inflammation.
According to Medline Plus, cases of vasculitis involve inflammation of blood vessels. The condition happens because the body’s immune system attacks the blood vessels by mistake. Several factors can trigger this inflammation, including infection, a medicine, or another disease.
Recent research has linked the condition with receiving an injection of Syfovre.
The American Academy of Ophthalmology reports that retinal vasculitis can cause several symptoms:
Other symptoms of vasculitis can include:
The main goal of treatment is to reduce inflammation. Often, physicians prescribe steroids and other anti-inflammatory medicines to help.
Studies have linked the condition with the use of Syfovre, a medication used for various health conditions.
With this condition, the patient experiences inflammation of the blood vessels in the retina. This inflammation can lead to a range of symptoms, including vision loss.
Early diagnosis and intervention are crucial in managing retinal vasculitis. The long-term prognosis can vary, depending on the severity of the condition and the effectiveness of the treatment.
Acute retinal vascular occlusions happen when sudden blockages hinder supply of blood to the retina.
Retinal vein occlusion (RVO) and retinal artery occlusion are related conditions that affect the blood vessels in the retina. They differ in important ways.
RVO happens when there is a partial or total blockage in a vein that drains blood away from the retina. The retina is a layer of tissue at the back of the eye that helps us see by translating light into images. Consider these two types of RVO:
Retinal artery occlusion is a blockage in a retinal artery, which supplies oxygenated blood to the retina. According to The Lancet, this condition is a common cause of visual impairment. The condition can happen suddenly and cause vision loss without presenting pain.
Retinal artery occlusion can cause permanent vision loss. The condition can be especially severe if it involves blockage of the central retinal artery.
According to Healthline, some people with this condition may develop new blood vessels in their iris or retina. These new blood vessels can bleed and cause more vision loss by leading to vitreous hemorrhage or glaucoma.
Each retinal vascular condition presents its own set of symptoms.
According to the Cleveland Clinic, symptoms of retinal vein occlusion usually affect one eye and include:
Sometimes, you might not have any symptoms until complications occur. An eye doctor might discover the condition during a routine eye exam.
The American Academy of Ophthalmology says the main sign of retinal artery occlusion is sudden vision loss in one eye. This vision loss can affect part or all of your eye.
Other symptoms can include:
If you or a loved one experienced retinal vasculitis or retinal vascular occlusion following a Syfovre injection for GA, please reach out to our office for a free, no-obligation consultation. Call us at (800) 277-1193 or fill out the Case Evaluation Form at the bottom of this page.
Early diagnosis is crucial for managing Syfovre Retinal Vasculitis. If you experience any of the symptoms, it’s important to seek medical attention immediately.
Treatment for this condition typically involves managing inflammation. Doctors achieve this through medication, laser therapy, or surgery. The following are common treatment options for retinal vasculitis:
Remember, each patient is unique. The best treatment plan for you will depend on your specific symptoms, overall health, and response to previous treatments.
Acute retinal vascular occlusions are common causes of vision problems. Both retinal artery occlusions and retinal vein occlusions link to older age and heart health risks. However, they have different causes, effects on the body, and treatments.
Retinal artery occlusions require a team of neurologists specializing in strokes. However, eye doctors typically treat retinal vein occlusions. Managing overall health risks with help from primary care doctors is an important part of treating both conditions.
Lately, more patients have been filing lawsuits against Syfovre for causing retinal vasculitis and/or retinal vascular occlusion after receiving a Syfovre pegcetacoplan injection.
The lawsuits typically allege that the manufacturer, Apellis Pharmaceuticals, failed to adequately warn about the risk of retinal vasculitis and retinal vascular occlusion and that there were defects in the way the product was manufactured. In some cases, they also claim that the company was negligent in its duty to ensure the safety of its product.
The process of filing a Syfovre lawsuit can be complex. It often involves gathering medical records, consulting with legal and medical experts, and navigating the legal system.
The amount of compensation you could recover depends on the unique facts of your case. These factors include:
Lawyers and settlement attorneys play an important role in these cases. They provide legal advice, represent the patient’s interests, and negotiate settlements on their behalf.
When dealing with Syfovre lawsuits, legal representation offers several benefits.
Remember, choosing the right lawyer can make a significant difference in your case. Select a law firm with experience in medical device and pharmaceutical lawsuits and a track record of success.
Filing a Syfovre lawsuit to receive compensation for damages for your for retinal vasculitis can be a complex process.
Multiple forms of scientific research have shown the the potential for injuries from Syfovre injection treatments and pegcetacoplan treatments.
The outcome of a Syfovre lawsuit can vary greatly. It depends on the specifics of your case.
In some instances, the court may rule in favor of the plaintiff. This could result in a monetary award to cover medical expenses, lost wages, and pain and suffering.
In other cases, the lawsuit may result in a settlement. This is an agreement between the plaintiff and the defendant to resolve the case without a trial.
Regardless of the outcome, it’s important to remember that legal proceedings can take time. Patience and persistence are key.
Choosing the right attorney for your Syfovre lawsuit is crucial. Look for a law firm or attorney with experience in pharmaceutical litigation and medical device lawsuits. Also check for the law firm’s track record of success. Consider how many litigations they have won for their clients, as well as their results in terms of verdicts, court awards, and settlements.
Remember, this person will be your advocate. They will fight for your rights and help you navigate the complex legal landscape.
Syfovre-caused retinal vasculitis and retinal vascular occlusion are serious conditions. Both can have a significant impact on a person’s life.
If you or a loved one has suffered the effects of these injections, seek both medical and legal help. A knowledgeable attorney can guide you through the process of filing a lawsuit or seeking a settlement.
Here are some resources for support:
Remember, you’re not alone. There are people and organizations ready to help.
Levin Papantonio law firm has been fighting for the rights of people who have been injured by defective medical devices, drug injuries, and defective products. To date, we have achieved verdicts and settlements in excess of $80 billion on behalf of our clients. Let us take on the pursuit of justice on your behalf so you can focus on your recovery.
If you or a loved one developed retinal vasculitis or retinal vascular occlusion after receiving a Syfovre injection for geographic atrophy, please contact our office for a free case review. You can call us at (800) 277-1193 or complete the Case Evaluation Form at the bottom of this page.
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