FDA calls for new trial before it can approve Alimera’s Iluvien

18 October 2013

USA-based ophthalmic biopharma specialist Alimera Sciences (Nasdaq: ALIM) says that it has received a third Complete Response Letter (CRL) from the Food and Drug Administration relating to its New Drug Application for Iluvien (fluocinolone acetonide intravitreal insert).

Alimera tumbled 26.6% to $1.98 in morning trading Friday, while those of Australia’s pSivida (ASX: PVA). From with the drug was licensed, sank 35.1% to $2.46.

The dug is intended to treat vision impairment associated with chronic diabetic macular edema (DME). Alimera’s plunged 35.4% to $1.75 in early morning trading on October 18, when the news was revealed.

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