STAT+: Apellis safety probe of eye disease drug identifies injection needle as possible cause of severe side effect
Apellis Pharmaceuticals said it had identified a possible cause of severe eye inflammation reported in some patients receiving the treatment.
Apellis Pharmaceuticals said Tuesday that it had identified “internal structural variations” in a type of needle used by doctors to prepare syringes of its eye disease drug Syfovre as a possible cause of severe eye inflammation reported in patients receiving the treatment — but the company stopped short of definitively linking the needle to the cases.
Additionally, Apellis confirmed one additional case of the severe and potentially blinding side effect, known as retinal occlusive vasculitis, or ROV, that occurred in May. But with thousands of more Syfovre eye injections also performed, the overall frequency of ROV remains unchanged and rare, even with the added scrutiny and increased physician monitoring.
Apellis shares rose 30% to $40 in Wednesday’s pre-market trading on the growing belief amongst investors that Syfovre’s safety crisis is abating.
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