Apellis recommends Syfovre injection kits with 18-gauge filter needles
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Key takeaways:
- Apellis is exclusively distributing injection kits with the 18-gauge filter needle.
- There are eight confirmed reports of retinal vasculitis and two unconfirmed reports.
Apellis Pharmaceuticals has identified internal structural variations in the 19-gauge filter needle included in certain Syfovre injection kits as part of its investigation into the recent reports of retinal vasculitis.
The company is now exclusively distributing injection kits with the 18-gauge filter needle, according to a press release.
In addition, Apellis recommended that ophthalmologists “immediately discontinue use of any injection kits that contain the 19-gauge filter needle and use injection kits with the 18-gauge filter needle, which are already in distribution.”
“This recommendation is out of an abundance of caution as patient safety is our top priority,” Caroline Baumal, MD, chief medical officer of Apellis, said in the release.
There has been no established causal relationship between the identified variations in the 19-gauge filter needle and the safety events associated with Syfovre (pegcetacoplan injection), which is approved for the treatment of geographic atrophy secondary to age-related macular degeneration.
Apellis has eight confirmed reports of retinal vasculitis, with the latest occurring on June 20. Two reports of suspected retinal vasculitis, one in May and one in August, have not been confirmed.
There have been more than 100,000 vials of Syfovre distributed for administration in real-world cases and clinical trials, “and the events of retinal vasculitis continue to be very rare at an estimated real-world rate of 0.01% per injection,” Baumal said.
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