UPDATE 1-Alimera Sciences eye therapy gets FDA priority review
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Alimera Sciences Inc
ALIM.O
$8.10
-0.07-0.86%12:00am EDT
Mon Aug 30, 2010 6:15pm EDT
* Alimera expects FDA response in Q4
* Shares up 5 pct in extended trade
Aug 30 (Reuters) - Alimera Sciences Inc (ALIM.O) said its experimental eye drug to treat retinal swelling got priority review status from U.S. health regulators, sending its shares up 5 percent.
The late-stage drug, Iluvien, is being developed for the treatment of diabetic macular edema -- the most prevalent cause of moderate vision loss in patients with diabetes.
The Alpharetta, Georgia-based company said with the priority review status, it could receive a response from the U.S. Food and Drug Administration in the fourth quarter regarding its new drug application.
Priority review status implies the agency would aim to complete its analysis of the application within six months, rather than within the standard 10-month review period.
The FDA reserves priority review designation for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.
Alimera said it expects to file for Canadian marketing approval in September.
The company's shares, which debuted on Nasdaq in April, were up 5 percent at $8.50 after the bell. They closed at $8.10 Monday. (Reporting by Krishnakali S
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