Alimera To Resubmit Iluvien With No New Studies
This article was originally published in Pharmaceutical Approvals Monthly
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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The Atlanta-based ophthalmology company hopes to succeed in third try with FDA, but must split its focus with Europe as it tries to roll out launches in several countries at once.
Plus news on recent financings by California Institute for Regenerative Medicine, Alimera Sciences, Durata Therapeutics and CoDa Therapeutics.
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