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FDA Denies Approval For Alimera Sciences Inc's Eye Implant-Reuters


Friday, 18 Oct 2013 07:21am EDT 

Reuters reported that Alimera Sciences Inc said U.S. health regulators declined to approve its eye implant for retinal swelling and indicated the need for a new clinical trial. The Company said the U.S. Food and Drug Administration identified concerns regarding the benefit to risk and safety profiles of Iluvien in its complete response letter. Iluvien is a sustained-release implant used to treat vision impairment associated with chronic diabetic macular oedema. The FDA also referenced deficiencies at the facility where Iluvien is manufactured, Alimera said. 

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