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FDA rejects drug for treatment of diabetic macular edema

The Food and Drug Administration (FDA) announced that the investigational drug Iluvien cannot be approved in its present form for the treatment of diabetic macular edema. Alimera Sciences Inc. and pSdivida Corp. developed Iluven. A New Drug Application was submitted back in June in hopes of marketing Iluvien. Following review of the application, Priority Review Status was granted by the FDA at the end of August. Further review of the 24-months worth of safety and efficacy that was submitted with the application led the FDA to say that it requires 36-months' worth of safety and efficacy data as well as exploratory analyses. The 36-month data has been complied by Alimera and pSdivida and they are now organizing the analyses. In addition, the FDA found deficiencies in two third-party manufacturers used to produce the drug. Alimera says those manufacturers are addressing those problems.

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