Thu Dec 19, 2013 8:04am EST
<span id="articleText"/>(Reuters) - pSivida Corp and Alimera Sciences Inc said they would try a fourth time to get approval for an eye treatment for diabetes patients, sending the shares of both companies soaring.
<span id="midArticle_0"/>Alimera Sciences shares jumped 88 percent and pSivida stock climbed 62 percent in premarket trade.
<span id="midArticle_1"/>The drug-device combination, Iluvien, is a sustained-release eye implant used to treat vision loss associated with chronic diabetic macular edema (DME).
<span id="midArticle_2"/>It has been rejected by U.S. health regulators three times, most recently in October due to safety concerns.
<span id="midArticle_3"/>PSivida said the companies would resubmit a U.S. marketing application for an eye treatment in the first quarter of next year.
<span id="midArticle_4"/>PSivida said its partner Alimera, which has the rights to sell the treatment, planned to respond to the latest rejection addressing manufacturing concerns raised by the regulator, along with safety data from patients receiving the treatment in Germany and the United Kingdom.
<span id="midArticle_5"/>Alimera, which is currently in discussions with the FDA about treatment details to go on the label if the treatment is approved, does not need to conduct additional trials prior to approval, pSivida said.
<span id="midArticle_6"/>"We believe the fact that labeling discussions are being held could likely indicate that an agreement can be reached for a label with a favorable risk/benefit for DME patients," Ladenburg Thalmann analyst Juan Sanchez wrote in a note.
<span id="midArticle_7"/>"Therefore, we believe the probability of Iluvien approval in 2014 is high", Sanchez said raising his price target on the stock to $6 from $2.75.
<span id="midArticle_8"/>The U.S. Food and Drug Administration (FDA) told Alimera that an advisory committee meeting scheduled to review the treatment in January was no longer necessary, pSivida said.
<span id="midArticle_9"/>PSivida sold the rights to Iluvien to Alimera in 2005 but will receive 20 percent share of net profit from any sales.
<span id="midArticle_10"/>Sanchez estimates U.S. sales of about $250 million for Iluvien, if it is approved.
<span id="midArticle_11"/>Iluvien is already in use in Germany and Britain and has won approval in Austria, Portugal, Spain and France.
<span id="midArticle_12"/>DME, a type of swelling brought on by diabetes, can eventually lead to blindness.
<span id="midArticle_13"/>Alpharetta, Georgia-based Alimera Sciences closed at $2.55 on the Nasdaq on Wednesday. Watertown, Massachussets-based pSivida closed at $2.97.
<span id="midArticle_14"/>(Reporting by Natalie Grover in Bangalore)
<span id="midArticle_15"/>
<span id="articleText"/>(Reuters) - pSivida Corp and Alimera Sciences Inc said they would try a fourth time to get approval for an eye treatment for diabetes patients, sending the shares of both companies soaring.
<span id="midArticle_0"/>Alimera Sciences shares jumped 88 percent and pSivida stock climbed 62 percent in premarket trade.
<span id="midArticle_1"/>The drug-device combination, Iluvien, is a sustained-release eye implant used to treat vision loss associated with chronic diabetic macular edema (DME).
<span id="midArticle_2"/>It has been rejected by U.S. health regulators three times, most recently in October due to safety concerns.
<span id="midArticle_3"/>PSivida said the companies would resubmit a U.S. marketing application for an eye treatment in the first quarter of next year.
<span id="midArticle_4"/>PSivida said its partner Alimera, which has the rights to sell the treatment, planned to respond to the latest rejection addressing manufacturing concerns raised by the regulator, along with safety data from patients receiving the treatment in Germany and the United Kingdom.
<span id="midArticle_5"/>Alimera, which is currently in discussions with the FDA about treatment details to go on the label if the treatment is approved, does not need to conduct additional trials prior to approval, pSivida said.
<span id="midArticle_6"/>"We believe the fact that labeling discussions are being held could likely indicate that an agreement can be reached for a label with a favorable risk/benefit for DME patients," Ladenburg Thalmann analyst Juan Sanchez wrote in a note.
<span id="midArticle_7"/>"Therefore, we believe the probability of Iluvien approval in 2014 is high", Sanchez said raising his price target on the stock to $6 from $2.75.
<span id="midArticle_8"/>The U.S. Food and Drug Administration (FDA) told Alimera that an advisory committee meeting scheduled to review the treatment in January was no longer necessary, pSivida said.
<span id="midArticle_9"/>PSivida sold the rights to Iluvien to Alimera in 2005 but will receive 20 percent share of net profit from any sales.
<span id="midArticle_10"/>Sanchez estimates U.S. sales of about $250 million for Iluvien, if it is approved.
<span id="midArticle_11"/>Iluvien is already in use in Germany and Britain and has won approval in Austria, Portugal, Spain and France.
<span id="midArticle_12"/>DME, a type of swelling brought on by diabetes, can eventually lead to blindness.
<span id="midArticle_13"/>Alpharetta, Georgia-based Alimera Sciences closed at $2.55 on the Nasdaq on Wednesday. Watertown, Massachussets-based pSivida closed at $2.97.
<span id="midArticle_14"/>(Reporting by Natalie Grover in Bangalore)
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