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Alimera To Resubmit Iluvien With No New Studies

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has twice rebuffed Alimera’s marketing application for the intravitreal insert, which releases a corticosteroid to treat chronic diabetic macular edema, citing a bad risk/benefit balance. But after meeting with the agency in the second quarter, the company is confident a reanalysis of pivotal data will satisfy the agency.

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