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Syfovre Eye Injections: Lawsuit & Vision Loss in 2024

The Geographic Atrophy (GA) drug Syfovre (pegcetacoplan injection) has recently been linked to serious eye problems including retinal vasculitis and retinal vascular occlusion. These Syfovre side effects can permanently damage your eyesight and even lead to blindness.
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What is Syfovre?

Syfovre (pegcetacoplan) is used to treat a severe eye problem called geographic atrophy (GA) from age-related macular degeneration (AMD). The medication is administered as an injection directly into the back of the patient’s eye by a healthcare provider. Syfovre is manufactured and marketed by Apellis Pharmaceuticals, Inc., and was approved by the U.S. Food and Drug Administration (FDA) in February 2023.

According to Retina Today, 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 [1].

Eye Problems Linked to Syfovre Injection

According to the American Society of Retinal Specialists (ASRS), the research and safety in therapeutics committee in July 2023 issued a member communication [2] indicating more than a dozen reports of retinal vasculitis and retinal vascular occlusion in patients who received the Syfovre injection. To date, Apellis Pharmaceuticals is aware of at least 12 events of retinal vasculitis and 2 additional suspected cases linked to Syfovre side effects.

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 stated.

Syfovre Side Effects

  • Vision loss
  • Severe eye inflammation
  • Blind spots
  • Blurred vision
  • Floaters or flashes
  • Eye pain
  • Partial or total loss of vision (blindness)
  • Retinal vasculitis
  • Retinal vascular occlusion
  • Infectious endophthalmitis
  • Intra-ocular inflammation (IOI)
  • Occlusive retinal vasculitis

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 conjectured that transferring Syfovre medication into syringes for commercial use may lead to contamination or infection. Patients and healthcare professionals should closely monitor for any adverse health complications following a Syfovre injection.

Has a Syfovre Recall Been Issued?

According to the FDA, to date, Syfovre has not been recalled by Apellis Pharmaceuticals. However, in Nov. 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 [3].

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.

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). This disease primarily affects the macula and is characterized by well-defined areas of degeneration in the outer retinal tissue, the retinal pigment epithelium (RPE), and the underlying choriocapillaris.

GA typically begins around the perifoveal area and gradually spreads to the central fovea, eventually leading to central scotomas and irreversible loss of central vision.

Over 8 million people are affected worldwide with GA, approximately 20% of all individuals with AMD. The incidence of GA is expected to rise as the age burden of developed countries increases.

Geographic Atrophy Symptoms

  • Decreased sharpness and clarity of vision.
  • Challenges in activities that require detailed central vision such as reading, driving, or engaging in crafts.
  • Presence of a dark or blind spot in the center of the visual field.
  • Problems with visibility in low-light conditions.
  • Colors appear faded or less intense.

Source: Cleveland Clinic [4].

How is Geographic Atrophy Treated?

An eye care specialist may recommend the following strategies to help manage geographic atrophy:

  • Visual Rehabilitation: This could involve the use of special prescription glasses or visual enhancement devices like magnifying glasses to support daily activities.
  • AREDS2 Supplements: Originating from the Age-Related Eye Disease Study, these supplements contain antioxidants and are commonly used to manage dry AMD. Unlike the AREDS1 formula, which includes beta-carotene known to increase lung cancer risk in smokers, AREDS2 is formulated with lutein, zeaxanthin, vitamin E, zinc oxide, and cupric oxide, offering a safer alternative for all patients, including smokers.
  • Implantable Miniature Telescope (IMT): This surgical option involves replacing the eye’s natural lens with an IMT, which enlarges objects in the central vision. This magnification helps project images onto healthier parts of the retina, aiding those with central vision loss.

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Get a Free Syfovre Lawsuit Evaluation With Our Lawyers

The Pharmaceutical Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Syfovre Lawsuits. We are handling individual litigation nationwide and currently accepting new Syfovre lawsuits in all 50 states.

If you or a loved one suffered vision-related side effects from Syfovre, you should contact our attorneys immediately. You may be entitled to financial compensation by filing a Syfovre lawsuit and we can help.

References:

1. https://retinatoday.com/articles/2023-oct-insert/syfovre-insights-on-case-reports-of-retinal-vasculitis
2. https://www.asrs.org/clinical/clinical-updates/10359/New-ReST-Committee-Report-Published
3. https://my.clevelandclinic.org/health/diseases/24890-geographic-atrophy
4. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217171s001lbl.pdf

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