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The FDA has approved Alimera Sciences’ fluocinolone acetonide intravitreal implant (Iluvien) for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in IOP.
Atlanta-The FDA has approved Alimera Sciences’ fluocinolone acetonide intravitreal implant (Iluvien) for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in IOP.
The treatment was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.
"We are very excited with this news from the FDA and thank the many people who contributed to this outcome and believed in (the treatment), including the retinal specialists, clinical site personnel, reading centers, and the many patients and their caregivers for helping us bring this long-term treatment to people in the United States with DME," said Dan Myers, president and chief executive officer of Alimera. "The approval of (the treatment) under this broader label brings a DME treatment to the United States that lasts years, not months, after a single injection and greatly expands the addressable market opportunity in the United States."
The company had previously resubmitted a New Drug Application for the treatment to the FDA in April, which provided a safety update-including commercial experience with the product in Europe-and responded to questions raised in an October 2013 complete response letter from the governmental agency.
With this week’s FDA approval, Alimera said it expects to begin selling the treatment in the United States during the first quarter of 2015.
In the meantime, the company will hold a conference call Wednesday at 8:30 a.m. ET to discuss the approval. The call will be hosted by Myers and Rick Eiswirth, chief operating officer and chief financial officer.
More information will be available on the Investor Relations section of the corporate website at www.alimerasciences.com.
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