Market Overview

pSivida Receives CRL from FDA for ILUVIEN

pSivida Corp. (NASDAQ: PSDV) today announced that its licensee
Alimera Sciences, Inc. has received a Complete Response Letter (CRL) for
the New Drug Application (NDA) for ILUVIEN® from the U.S. Food and Drug
Administration (FDA).

Identifying concerns regarding the benefit to risk and safety profiles
of ILUVIEN, the FDA stated that the NDA could not be approved in its
present form. To address the clinical and statistical deficiencies
identified, the FDA indicated that results from a new clinical trial
would need to be submitted, together with at least 12 months of
follow-up for all enrolled

See full press release

Posted-In: Earnings News Guidance Contracts Buybacks FDA Legal Management

 

Related Articles (PSDV)

Around the Web, We're Loving...

Partner Network

Get Benzinga's Newsletters

Benzinga Professional