Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval.  The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year.  The FDA requested that they be given data extending for a 3 year period instead of the 2 years in the new drug application.

Full Story →

At that time, Alimera Sciences, the company developing Iluvien (under license from pSivida) had filed a new drug application (NDA) to treat diabetic macula edema (DME). The company obtained priority review status for the NDA at the end of August, raising the expectation that an approvable letter might be obtained by the end of 2010. However, instead of an approvable letter, Alimera Sciences received a “complete response letter” (CRL) from the FDA, communicating to the company that its NDA application “cannot be approved in its present form”.

Full Story →