Alimera Sciences (NASDAQ:ALIM) is confident that it can resolve questions from the Food & Drug Administration about the company’s proposed treatment for diabetic macular edema (DME) in the first quarter of the year, President and CEO Dab Myers said Monday.
The FDA sent Alimera a request known as a Complete Response Letter last week asking for data about safety and efficacy of Iluvien through the end of a three-year trial that wrapped up in October. Alimera had submitted 24-month data with its new-drug application June 29.
The agency also raised questions about manufacturing facilities Alimera has lined up to produce the drug after approval.
“The letter we received was fairly specific,” Myers said in a conference call with investment analysts. The company has asked for a meeting in the first week of February, he said, adding, “I’m very confident” the company can answer the FDA’s questions then and get the approval process moving again.
Iluvien is a sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide to treat DME.
“Alimera … is preparing the analyses the FDA requested. The FDA is also seeking additional information regarding controls and specifications concerning the
manufacturing, packaging and sterilization of Iluvien, which Alimera is in the process of compiling,” the company said in a statement.
Myers said the manufacturers, whom he did not name, are addressing the FDA’s concerns about good manufacturing practices. The agency looked at the plants in August and September.
Intersouth Partners of Durham,N.C., is an investor in Alimera.
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