Industry News — Clinical Updates

Alimera Resubmits New Drug Application for Iluvien

Alimera Sciences, Inc. (Alpharetta, GA) announced today that it has resubmitted a New Drug Application to the US Food and Drug Administration (FDA) for Iluvien (sustained-release fluocinolone acetonide implant). In the resubmission, Alimera responded to questions raised in the FDA's October 2013 complete response letter and provided a safety update, which included commercial experience with Iluvien in Europe.

Alimera is now awaiting the FDA's acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date.

Iluvien has received marketing authorizations in Austria, the United Kingdom, Portugal, France, Germany, and Spain and is commercially available in the United Kingdom and Germany.

Also read: UK’s NICE Issues Final Guidance for Iluvien

Updated: March 27, 2014