Clear­side Bio­med­ical pre­dicts its uveitis drug will be re­ject­ed, af­ter FDA re­quests more da­ta

In its sec­ond-quar­ter up­date ear­li­er this month, eye drug de­vel­op­er Clear­side Bio­med­ical in­di­cat­ed it was look­ing to out-li­cense its lead drug, Xipere, which is cur­rent­ly un­der FDA re­view. But those plans may be put on hold af­ter the com­pa­ny on Thurs­day dis­closed the FDA has asked for more da­ta on the drug’s mar­ket­ing ap­pli­ca­tion.

As a re­sult, Clear­side ex­pects to re­ceive a Com­plete Re­sponse Let­ter from the FDA on or be­fore the de­ci­sion date of Oc­to­ber 19, it said. The drug, Xipere (tri­am­ci­nolone ace­tonide oph­thalmic sus­pen­sion), is be­ing eval­u­at­ed for the treat­ment of mac­u­lar ede­ma as­so­ci­at­ed with uveitis, which is char­ac­ter­ized by in­flam­ma­tion of the mid­dle lay­er of the eye.

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