Slide continues for pSivida, Alimera after FDA rejection

November 15, 2011 by MassDevice staff

Shares of pSivida and Alimera Sciences continue to slide after the FDA rejects their Iluvien drug-device combination for diabetic macular edema.


Shares of pSivida Corp. (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) slid today on an FDA rejection of their Iluvien drug-device combination.

The federal watchdog agency said it couldn't approve Iluvien, a back-of-the-eye implant designed to treat diabetic macular edema, because Alimera hadn't proven that its benefits outweigh its safety risks. The FDA wants Alimera, which licenses the device from pSivida, to conduct two more clinical studies for Iluvien for DME.

pSivida shares fell 12.0 percent today to $1.40, hitting a 52-week low of $1.36 along the way and adding to the nearly 50 percent lost Friday, after the FDA decision was announced.*

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"I can only reiterate how surprised and disappointed we were by this news. We have had two other back-of-the-eye products previously approved by the FDA and we were optimistic that the FDA would approve Iluvien for DME," pSivida CEO Dr. Paul Ashton told analysts on a conference call. "Because we have licensed Iluvien to Alimera, the next steps for Iluvien development in DME in the US will be decided by Alimera, not us. We don't participate in running the clinical trials or developing the regulatory strategy for the DME program."

ALIM shares suffered as well, dropping 276 percent Friday and another 5.2 percent today, hitting it's own 52-week low of $1.39 on the way to a $1.50 close.