Apellis' safety probe into eye drug unearths issues with injection kits, while side effects remain 'very rare'
Apellis has found a possible culprit for the safety events affecting a small number of patients who received its geographic atrophy treatment — and the injection kit, not the drug itself, may be to blame.
Following a comprehensive investigation, Apellis said it identified “internal structural variations” in the 19-gauge filter needle that’s used in some of its injection kits for Syfovre (pegcetacoplan). It did not find a causal relationship between those structural variations and the cases of retinal vasculitis reported during real-world use of Syfovre. But it is advising healthcare practitioners to stop using kits with the 19-gauge filter needle and switch to using those with the 18-gauge filter needle, which is used to withdraw the drug solution from the vial.
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