Alimera shares leap on FDA filing for lead program approval

Alpharetta, GA-based Alimera Sciences managed to buck a rough morning on Wall Street as its shares were buoyed by the announcement that the developer has submitted its lead therapy of diabetic macular edema for FDA approval. ALIM shares were up about eight percent on the news, touching $8.70.

Alimera submitted Iluvien, (fluocinolone acetonide intravitreal insert), a sustained drug delivery system which releases tiny quantities of fluocinolone acetonide for DME. And the company says that it hopes to get a positive, accelerated decision before the end of this year.

"This is a significant milestone for all of us at Alimera, and represents a major advance toward a rapid and sustained visual acuity benefit for DME sufferers," said Alimera CEO Dan Myers. "We believe that Iluvien, if approved, will provide a needed alternative to the multiple injections of corticosteroids and anti-VEGF therapies used off-label for extended efficacy in DME. We believe this would be the first ophthalmic drug therapy to be approved for DME and the only DME treatment that works in terms of years, not months."

Despite the one-day bump, Alimera has had a hard time making a case to investors. The developer went public about two months ago after slashing its share price to $11 after reaching for $15 to $17. The stock price has fallen significantly since the IPO was completed. Alimera is partnered with pSivida on the program, which holds a minority interest in the therapy.

- here's the Alimera release

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