Does an im­proved safe­ty pro­file strength­en Al­ler­gan's case for a wet AMD chal­lenge to Lu­cen­tis?

Al­ler­gan has chalked up some flat­ter­ing safe­ty da­ta for abic­i­par as it re­fines the eye drug’s man­u­fac­tur­ing process­es in prepa­ra­tion of an im­pend­ing BLA fil­ing. But whether or how much that mat­ters is still up for de­bate.

In an open-la­bel, sin­gle-arm study, in­ves­ti­ga­tors re­port­ed that the in­ci­dence of in­traoc­u­lar in­flam­ma­tion was 8.9% — low­er than the rate ob­served in pri­or Phase III stud­ies, which hov­ered around 15%. The MAPLE tri­al re­cruit­ed 123 age-re­lat­ed neo­vas­cu­lar mac­u­lar de­gen­er­a­tion (or wet AMD) pa­tients and ad­min­is­tered the in­jec­tion five times over 28 weeks.

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