Alimera submits Iluvien NDA for DME to FDA Alimera Sciences.

Alimera submits Iluvien NDA for DME to FDA Alimera Sciences, Inc., , , a biopharmaceutical company that specializes in the study, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Software to the U .S. In the submission, Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth one fourth of 2010. Related StoriesLiposomal sizing and the Coulter principle: an interview with Professor Melvin E. We believe this might be the first ophthalmic medication therapy to be accepted for DME and the just DME treatment that works when it comes to years, not a few months. The primary efficacy endpoint for the FAME Study may be the difference in the %age of patients whose best corrected visible acuity improved by 15 or even more letters from baseline on the ETDRS eyes chart at month 24 between the treatment and control organizations.

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