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….

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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