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Table Of Contents
- Syfovre Lawsuit Overview
- Latest Syfovre Lawsuit Updates
- FDA Reports and Statistics
- Syfovre Injuries & Side Effects
- Do You Qualify for a Syfovre Lawsuit?
- Syfovre Recall Information
- Statute of Limitations for Syfovre Lawsuits
- FAQs
- 1. What is Syfovre?
- 2. What is geographic atrophy?
- 3. What are the symptoms of geographic atrophy?
- 4. What are the serious side effects associated with Syfovre?
- 5. What compensation might I receive from a Syfovre lawsuit?
- 6. Is there a deadline for joining the Syfovre lawsuit?
- 7. Can I file a lawsuit if I took Syfovre but did not suffer any harm?
- Get a Free Syfovre Lawsuit Evaluation With Our Lawyers
Syfovre Lawsuit Overview
Syfovre lawsuits focus on severe eye injuries allegedly caused by this medication used to treat geographic atrophy.
According to the American Society of Retinal Specialists (ASRS), there have been more than a dozen reports of retinal vasculitis and retinal vascular occlusion in patients who received Syfovre injections.
Apellis Pharmaceuticals is aware of at least 12 confirmed events of retinal vasculitis and 2 additional suspected cases, with patients developing visual symptoms 8-18 days following treatment.
Latest Syfovre Lawsuit Updates
- November 2023 – Apellis Pharmaceuticals updated the Warnings and Precautions section of the Syfovre prescribing information to include a warning for retinal vasculitis and/or retinal vascular occlusion [1]. The label now states that these complications may occur with the first dose and may result in severe vision loss.
- July 2023 – The American Society of Retinal Specialists (ASRS) research and safety in therapeutics committee issued a member communication indicating more than a dozen reports of retinal vasculitis and retinal vascular occlusion in patients who received Syfovre injections [2].
- February 2023 – Syfovre (pegcetacoplan) received FDA approval for the treatment of geographic atrophy (GA) from age-related macular degeneration (AMD). The approval was based on the ability of Syfovre to reduce the rate of GA lesion growth in the phase 3 DERBY and OAKS studies [3].
FDA Reports and Statistics
According to the ASRS, patients who developed complications from Syfovre had symptoms appear between 8 to 18 days following treatment, with a median of 11 days.
The clinical presentations of retinal vasculitis varied widely, with some cases showing focal intraretinal hemorrhages and vascular leakage, while others presented with peripheral non-perfusion.
Geographic atrophy (GA), the condition that Syfovre treats, affects over 8 million people worldwide, representing approximately 20% of all individuals with age-related macular degeneration (AMD). The incidence of GA is expected to rise as the population ages in developed countries.
Despite conducting approximately 12,000 injections in the phase 3 trials and more than 24,000 injections to date, no cases of vasculitis were identified in any of the Syfovre clinical trials.
However, post-marketing reports have emerged showing serious complications in some patients.
The approval was based on the ability of SYFOVRE to reduce the rate of GA lesion growth and a well demonstrated safety profile following approximately 12,000 injections in the phase 3 DERBY and OAKS studies. No cases of vasculitis were identified in any of the SYFOVRE clinical trials, representing more than 24,000 injections to date.- Retina Today.
Syfovre Injuries & Side Effects
Syfovre injections have been linked to serious vision-threatening side effects that can occur even after a single dose of the medication.
- Retinal Vasculitis: Inflammation of the blood vessels in the retina that can lead to severe vision loss.
- Retinal Vascular Occlusion: Blockage of blood vessels in the retina causing tissue damage and vision impairment.
- Vision Loss: Partial or total loss of vision (blindness) in the affected eye.
- Eye Inflammation: Severe inflammation within the eye including infectious endophthalmitis and intra-ocular inflammation.
- Visual Disturbances: Including blind spots, blurred vision, floaters, and flashes.
- Eye Pain: Severe discomfort in the treated eye following injection.
The cause of these Syfovre side effects is currently unknown, as Apellis has not found any problems associated with a specific batch of Syfovre.
However, ASRS members have suggested that transferring Syfovre medication into syringes for commercial use may lead to contamination or infection.
Do You Qualify for a Syfovre Lawsuit?
You may qualify for a Syfovre lawsuit if:
- You received Syfovre injections for the treatment of geographic atrophy.
- You experienced serious side effects such as retinal vasculitis, retinal vascular occlusion, or vision loss.
- Your symptoms appeared within days or weeks following the Syfovre injection.
- You required medical treatment for your eye complications.
- You can document a clear timeline between your Syfovre treatment and the onset of symptoms.
Evidence Required for a Syfovre Lawsuit
- Medical records confirming your geographic atrophy diagnosis and Syfovre treatment.
- Documentation of your eye complications and when they occurred.
- Medical opinions linking your injuries to the Syfovre injections.
- Records of all medical treatments for your eye injuries.
- Documentation of any permanent vision damage or impairment.
Damages You Can Recover
- Medical expenses for treatment of eye complications
- Future medical care costs for ongoing vision issues
- Lost wages and diminished earning capacity
- Pain and suffering related to vision impairment
- Loss of quality of life due to vision problems
- Punitive damages if applicable
Syfovre Recall Information
According to the FDA, to date, Syfovre has not been recalled by Apellis Pharmaceuticals.
However, in November 2023, Apellis updated the Warnings and Precautions section of the Syfovre prescribing information to include a warning for retinal vasculitis and/or retinal vascular occlusion [4].
The updated warning states:
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.
Patients developed visual symptoms from eight to 18 days following treatment with SYFOVRE with a median of 11 days. Reported cases of retinal vasculitis had a broad spectrum of clinical presentation. Some cases had focal intraretinal hemorrhages and vascular leakage, while others presented with peripheral non-perfusion – ASRS.
Statute of Limitations for Syfovre Lawsuits
The statute of limitations for filing a Syfovre lawsuit varies by state, typically ranging from 1-3 years from the date of injury or from when you discovered your injury was connected to Syfovre use.
These timeframes can differ significantly based on your location and the specific circumstances of your case.
Because eye complications from Syfovre may develop days or weeks after treatment, the “discovery rule” may apply in some jurisdictions, which means the statute of limitations begins when you discovered or reasonably should have discovered that your injury was caused by Syfovre.
Given these complexities, it’s crucial to consult with an attorney as soon as possible after experiencing complications to ensure you don’t lose your right to seek compensation.
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FAQs
1. What is Syfovre?
Syfovre (pegcetacoplan) is a medication used to treat geographic atrophy (GA) from age-related macular degeneration (AMD). It is administered as an injection directly into the back of the patient’s eye by a healthcare provider. Syfovre was approved by the FDA in February 2023 and is manufactured by Apellis Pharmaceuticals.
2. What is geographic atrophy?
Geographic atrophy (GA) is a severe, progressive condition that is part of the advanced stages of age-related macular degeneration (AMD). It affects the macula and is characterized by well-defined areas of degeneration in the retinal tissue, eventually leading to central vision loss. Over 8 million people worldwide are affected by GA.
3. What are the symptoms of geographic atrophy?
Symptoms of geographic atrophy include decreased sharpness of vision, challenges with detailed central vision (reading, driving), a dark or blind spot in the center of vision, problems seeing in low light, and faded color perception [5].
4. What are the serious side effects associated with Syfovre?
Serious side effects of Syfovre include retinal vasculitis, retinal vascular occlusion, vision loss, severe eye inflammation, blind spots, blurred vision, floaters, eye pain, and in some cases, partial or total blindness. These complications typically appear 8-18 days after treatment.
5. What compensation might I receive from a Syfovre lawsuit?
Compensation can vary but may include medical expenses, lost wages, pain and suffering, and possibly punitive damages depending on the severity of the health issues experienced.
6. Is there a deadline for joining the Syfovre lawsuit?
Yes, there are statutes of limitations for filing a lawsuit, which vary by state. It is important to act promptly and consult with an attorney to ensure you file within the required timeframe.
7. Can I file a lawsuit if I took Syfovre but did not suffer any harm?
You may still be able to file a lawsuit if you were misled about the drug’s efficacy or if the drug posed a significant risk of harm. However, compensation may be limited compared to cases involving actual harm.
See all related dangerous drug lawsuits our attorneys covered so far.
Get a Free Syfovre Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action for injuries related to Syfovre injections. State statutes of limitations typically allow only 1-3 years from the date of injury or discovery to file a claim, making it crucial to act quickly to preserve your legal rights.
The Pharmaceutical Liability Litigation Group at Schmidt & Clark, LLP offers:
- Free, confidential consultations to evaluate your case
- No upfront costs or fees for our services
- Payment only if we win your case
- Nationwide representation accepting cases in all 50 states
If you or a loved one suffered vision-related side effects from Syfovre, contact our attorneys immediately to understand your legal options.
References
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217171s001lbl.pdf
- https://www.asrs.org/clinical/clinical-updates/10359/New-ReST-Committee-Report-Published-in-JVRD-Summarizes-Analysis-of-Reported-Case
- https://retinatoday.com/articles/2023-oct-insert/syfovre-insights-on-case-reports-of-retinal-vasculitis
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217171s001lbl.pdf
- https://my.clevelandclinic.org/health/diseases/24890-geographic-atrophy