pSivi­da lines up EMA, FDA ap­pli­ca­tions for eye drug/de­vice as 2nd PhI­II de­liv­ers pos­i­tive da­ta

Wa­ter­town, MA-based pSivi­da says their lead eye drug for pos­te­ri­or seg­ment uveitis hit the pri­ma­ry end­point of their sec­ond Phase III tri­al, putting them on track to a Eu­ro­pean fil­ing this month with an FDA ap­pli­ca­tion sched­uled to ar­rive in Q4.

The drug is de­signed to pre­vent a re­cur­rence of pos­te­ri­or seg­ment uveitis, which caus­es blind­ness, and re­searchers say that Durasert scored on that mark, with 21.8% in the drug arm ex­pe­ri­enc­ing a re­cur­rence com­pared to 53.8% in the place­bo arm.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER