A Syfovre Case of Hemorrhagic Occlusive Vasculitis-type Inflammation With Continued Blindness Is Reported
(Posted by Tom Lamb at Drug Injury Watch)
UPDATE: 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 Pharmaceuticals about the cause of Syfovre eye-related side effects:
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. [Emphasis added.]
(2/28/24)
At the 2023 Annual Meeting of the American Academy of Ophthalmology (AAO), various Syfovre patients eye side effects cases were discussed by William J. Johnson, M.D., of the Wolfe Clinic in Iowa. These Syfovre side effects cases range from hemorrhagic occlusive vasculitis-type inflammation with continued blindness to uveitis to vision loss to symptomatic floaters.
From this November 3, 2023 news report, "Details on 5 Cases of Complications From Syfovre Injections | AAO 2023", by Peter Wehrwein, Managing Editor of Managed Healthcare Executive, we get the following information about this significant Syfovre 2023 AAO Meeting presentation:
One of the patients experienced hemorrhagic occlusive vasculitis-type inflammation and continues to have no light perception — clinical terminology for blindness — in the treated eye, reported William J. Johnson, M.D., a retinal fellow at the Wolfe Clinic, which has 24 locations in Iowa.
Johnson... said Wolfe Clinic retina specialists administered 129 injections of Syfovre in 96 eyes of 84 patients between March 2023 and mid-July, when it paused used of Syfovre injections because of the complications.
Here are some of the details about the five cases Johnson presented at the AAO meeting. He provided a few more details in a subsequent phone conversation:
- An 80-year-old male who developed silicone oil droplet complications experienced symptomatic floaters. There was no objective change in vision or inflammation, but the patient decided not to have any further treatments....
- A 72-year old woman developed intermediate and anterior (front of the eye) uveitis following her first injection with Syfovre. Her vision returned to its baseline level after intensive topical steroid treatment.
- An 86-year-old woman developed uveitis after her second Syfovre injection. Her condition improved initially with steroid drops but then worsened. She was treated with antibiotic and steroid injections in the eye but did not improve. After more intense steroid treatment was started, her vision slowly improved over 10 weeks and returned to being just below baseline. Johnson said there was some debate about how this case should be classified, with Wolfe specialists seeing some findings as evidence pointing to pre-existing branch retinal vein occlusion but others seeing them as evidence of hemorrhagic vasculitis without occlusion.
- A 72-year-old female presented with vision loss seven weeks after a Syfovre injection. The person’s vision improved after three monthly treatments with Vabysmo (faricimab), an anti-vascular endothelial growth factor (VEGF) used to treat neovascular, or “wet,” age-related macular degeneration (AMD). She had converted from dry to wet AMD, and Johnson said such cases were seen in clinical trials of Syfovre and are a known complication. Her vision improved with the Vabysmo treatments but never fully recovered and remained below her baseline level.
The fifth case was the patient who experience no light perception in his treated eye. Johnson said he was a 96-year-old man who presented nine days after his first injection with decreased vision, pain, elevated pressure in the eye, and vasculitis. He was initially treated with antibiotics, steroids and topical eye hypertensives. That treatment was followed by stronger steroids and then by anti-VEGF therapy. Johnson said the baseline vision of the treated eye was 20/60.
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Suber S. Huang, M.D., MBA, said this Syfovre patients eye side effects cases presentation was one of the most important of this 2023 AAO Annual Meeting in San Francisco in early November. Notably, it was the first major AAO meeting since the FDA approved Syfovre in February 2023 to treat geographic atrophy (GA).
On November 4, 2023, Managed Healthcare Executive made available online a brief interview (2:49 video) with Dr. Huang on a page titled "Syfovre Complications Discussed in Late-Breakers Session | AAO 2023".
We have been following this still-developing drug safety issue involving Syfovre patients eye side effects cases since July 2023. Our most recent article, "Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further 'Explanation'", was posted last month, in mid-October 2023.
At present, 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.
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