Alimera To Resubmit Iluvien With No New Studies
This article was originally published in The Pink Sheet Daily
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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FDA cites concerns about safety and manufacturing in third “complete response” letter for intravitreal implant Iluvien in diabetic macular edema. Agency requests new trial and an advisory committee meeting in early 2014.
Triumphant in Europe at the regulatory stage, Alimera finds that health technology assessment is a different ball game, as NICE turns down Iluvien for diabetic macular edema on two counts.
Plus news on recent financings by California Institute for Regenerative Medicine, Alimera Sciences, Durata Therapeutics and CoDa Therapeutics.