FDA Issues "Complete Response" On Alimera's Iluvien; Eyes More Data
This article was originally published in The Pink Sheet Daily
The ophthalmology company received a “complete response” for lead product Iluvien.
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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.
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.
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.