(Reuters) - 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, sending the company's shares down 26 percent before the bell.
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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.
Alimera licensed the drug from pSivida Corp in 2005. PSivida's shares fell 56 percent in trading before the bell on Friday.
Iluvien is a sustained-release implant used to treat vision impairment associated with chronic diabetic macular oedema and has been approved for use in several European countries.
The FDA also referenced deficiencies at the facility where Iluvien is manufactured, Alimera said.
Alimera said it does not believe that these deficiencies will affect its European commercial supply.
(Reporting by Shailesh Kuber; Editing by Sriraj Kalluvila)
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