Lump of coal for Alimera's Iluvien

FDA issued a complete response letter for an NDA from Alimera Sciences Inc. (NASDAQ:ALIM) for Iluvien to treat diabetic macular edema (DME). The company said FDA did not request any additional clinical trials, but did ask for further analyses of safety and efficacy data through month 36 from the two Phase III FAME trials. Alimera, which has completed month 36 of the study, submitted data through month 24 in its NDA. The agency also noted cGMP deficiencies during facility inspections of two third-party manufacturers. Alimera said the manufacturers are in the process of resolving the deficiencies. The company has requested a meeting with FDA to clarify the regulatory path forward. ...