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Alimera plunges after FDA rejects Iluvien eye drug

Last updated: 05:59 12 Nov 2011 AEDT, First published: 06:59 12 Nov 2011 AEDT

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Biopharmaceutical company Alimera Sciences (NASDAQ:ALIM) saw its stock plunge Friday after it reported U.S. health regulators said there was not enough data to support a new drug application for Iluvien, used to treat diabetic patients macular edema, or swelling of the eye.

The Alpharetta, Georgia-based firm saw its stock tank $5.12, or 69.47 percent, falling to $2.25 a share Friday afternoon on Nasdaq.

The drug, known as Iluvien, is inserted in the back of the patient’s eye and is designed to administer therapeutic effects of up to 36 months by delivering sub-microgram levels of the drug.

Diabetic macular edema (DME) occurs when blood vessels in the retina of patients with diabetes begin to leak into the macula, the part of the eye responsible for detailed central vision. These leaks cause the macula to thicken and swell, progressively distorting acute vision.

Alimera estimates that close to one million people in the U.S. currently have DME and approximately 300,000 new cases develop each year.

In the complete response letter, the U.S. Food and Drug Administration (FDA) said the new drug application submitted by Alimera did not have sufficient data to support Iluvien as safe and effective in subjects suffering with DME.  The letter also said the benefits of Iluvien did not outweigh the risks of adverse reactions shown during clinical trials.

“We are surprised and disappointed with the FDA's decision on our application to market Iluvien in the U.S. to patients with this devastating disease,” chief executive Dan Myers said in a statement.

"Based on extensive research with U.S. retinal physicians, we have learned that Iluvien’s long-term sustained delivery treatment benefit is desired and that Iluvien has a manageable risk to benefit ratio."

The US regulator pointed out that Alimera will need to conduct two more clinical trials to illustrate whether Iluvien is safe and effective for its proposed indication.

A response letter is issued when a review of an application is completed and questions remain that precludes the approval of the new drug application.  Alimera said it has requested a meeting with the FDA to clarify next steps.

The biopharmaceutical company also said it is committed to pursuing approval in Europe for the drug and to evaluating its options in the U.S.

For Europe, the drug maker said it expects to submit a formal response to the preliminary assessment report to regulatory authorities there later this month. The agency will make a recommendation to approve the drug by year-end.

If approved, expected in the first half of 2012, the drug will be available in Austria, France, Germany, Italy, Portugal and Spain.

Alimera specializes in the development and commercialization of prescription eye drugs, and is focused on diseases that affect the back of the eye, or retina.

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