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pSivida Corp. Reports FDA Labeling Discussions for ILUVIEN® for DME; Advisory Committee Meeting No Longer Necessary

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pSivida Corp. (NASDAQ: PSDV) today announced that its licensee Alimera Sciences has entered into
labeling discussions with the U.S. Food and Drug Administration (FDA)
for ILUVIEN® for Diabetic Macular Edema (DME) and, as a result, reported
its agreement with the FDA that the January 2014 Dermatologic and
Ophthalmic Advisory Committee meeting to discuss ILUVIEN for DME was no
longer necessary.

Alimera reported that it plans to respond to the FDA's October 2013
Complete Response Letter (CRL) in the first quarter of 2014 and intends
to address the concerns raised regarding the facility at which ILUVIEN
for DME is

See full press release

Posted-In: News Guidance Financing FDA Management Global

 

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