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Alimera to resubmit Iluvien for FDA approval

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Alimera Sciences has indicated it will resubmit its application to the U.S. Food and Drug Administration for Iluvien for the treatment of diabetic macular edema, according to a news release from pSivida.

Alimera owns the global license to manufacture and sell pSivida’s sustained-release intravitreal implant, which delivers sub-microgram levels of fluocinolone acetonide for up to 36 months.

The resubmission is expected to use data from the phase 3 FAME study and focus on patients with chronic diabetic macular edema considered insufficiently responsive to available therapies, the release said. Iluvien has been granted marketing authorization for this indication in Austria, France, Germany, Portugal and the U.K.

Alimera has not reported when it will resubmit its application, according to the release.