Alimera says FDA advisory committee on Iluvien no longer necessary

US ophthalmic pharma specialist Alimera Sciences (Nasdaq: ALIM) has entered into labeling discussions with the US Food and Drug Administration for its fluocinolone acetonide intravitreal implant Iluvien and, as a result, reached an agreement with the FDA that Alimera's participation in the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting was no longer necessary.

Instead, Alimera will focus on drafting its response to the recent (third) Complete Response Letter (CRL) received from the FDA (The Pharma Letter October 18) with a goal of submitting the response in the first quarter of 2014. Iluvien is licensed from USA-based pSivida (Nasdaq: PSDV).

As a result of the news, Alimera’s skyrocketed 82% to $4.65, and pSivada gained nearly 55% to $4.60.