Reuters: Hot Stocks: UPDATE 2-FDA rejects again Alimera eye implant; shares plunge

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UPDATE 2-FDA rejects again Alimera eye implant; shares plunge Oct 18th 2013, 17:29 Share this Email Print Reprints Fri Oct 18, 2013 9:26am EDT (Adds details, updates stock) * FDA asks for new trial for Iluvien * Alimera shares fall 39 pct * PSivida, which sold Iluvien rights, plunges 48 pct Oct 18 (Reuters) - Alimera Sciences Inc said U.S. health regulators rejected for a third time its eye implant device due to safety concerns, sending its shares down 39 percent before the bell. Shares of pSivida Corp, which sold the rights to Iluvien to Alimera in 2005 but is in line for a 20 percent share of profits, almost halved. Iluvien, used to treat retinal swelling brought on by diabetes, has been approved by some European regulators but the U.S. Food and Drug Administration has rejected it three times in the past three years. The FDA raised concerns about the eye implant's safety profile in its complete response letter rejecting marketing approval, the company said on Friday. Marketing approval is the final OK needed to start selling a medical device in the United States. The FDA also referred to deficiencies at the facility where Iluvien is manufactured, Alimera said. Alimera said it did not believe that these deficiencies will affect its European commercial supply. The FDA suggested at least 12 months of follow-up for all enrolled patients in a new trial and a meeting with the regulator's advisory panel to address the deficiencies. The panel would advise whether a patient population can be identified in which the benefits of the drug might outweigh the risks, the FDA said. The panel will convene on Jan. 27. Iluvien is a sustained-release implant used to treat vision impairment associated with chronic diabetic macular oedema. (Reporting by Shailesh Kuber; Editing by Sriraj Kalluvila and Rodney Joyce) Link this Share this Digg this Email Reprints

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