FDA Kicks Dust on Alimera's Fairy Tale

Alimera Sciences (Nasdaq: ALIM) seemed like a Cinderella story. The biotech IPO'd last April and looked like it was on its way to gaining a Food and Drug Administration approval in the same year.

Then the FDA handed out a pre-Christmas lump of coal, refusing to approve Alimera's eye drug, Iluvien, to treat diabetic macular edema (DME). Investors were none too thrilled; shares opened today down more than 20% on the news, although they've bounced back some. pSivida (Nasdaq: PSDV), which helped develop Iluvien, is also hurting.

The agency wants to see three-year data on Iluvien instead of the two-year data Alimera used in its marketing application. Assuming the positive trend continues, this isn't that big of a deal as the trial is already through year three, and the company is working on compiling the data for the FDA.

The agency also has some issues with the manufacturing of Iluvien. Convincing the FDA that it can make the drug consistently might not be a big deal, but it's also a bit of an unknown. Dyax (Nasdaq: DYAX) took care of its manufacturing issues and got Kalbitor approved in about eight months. Savient Pharmaceuticals (Nasdaq: SVNT) took a little over a year to clear up issues with its gout treatment Krystexxa. At the other extreme, Discovery Labs is still trying to get its respiratory death syndrome treatment, Surfaxin, approved more than five years after the FDA first took issue with manufacturing of the drug.

The biggest unknown for Alimera resides in two of the company's third-party manufacturers needing to clear up issues with the FDA before the agency will approve Iluvien. Again, in theory, these issues could be relatively minor, but having an approval partially dependent on another company getting its act together doesn't give you a warm and fuzzy feeling.

Alimera is shooting for resubmitting to the FDA in the first quarter of next year. Assuming a six-month review, Alimera could be on the market in the third quarter of next year. Just keep in mind that this isn't fairyland; Cinderella can't go to the ball until she's got her chores done.