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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