Another FDA rejection for Alimera's DME drug Iluvien
Shares of US ophthalmic drug developer Alimera Sciences (Nasdaq: ALIM) plunged nearly 73% to $2 on Friday, when the company revealed that it has received a complete response letter (CRL) from the US Food and Drug Administration in response to the New Drug Application for Iluvien (fluocinolone acetonide intravitreal insert) for the treatment of diabetic macular edema (DME) associated with diabetic retinopathy.
Alimera announced last year that it had received a CRL from the FDA regarding its NDA for the investigational drug Iluvien, which is licensed from Australian drug delivery firm pSivida (The Pharma Letter December 24, 2010). The Australian firm’s shares also fell sharply, 44.5% to A$2.18. The US firm re-submitted the NDA in May this year.
FDA requests two additional trials
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