Shares of pSivida and Alimera Sciences continue to slide after the FDA rejects their Iluvien drug-device combination for diabetic macular edema.
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.
"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.
Alimera has asked the FDA for a meeting to discuss next steps and is suspending a clinical trial the FDA asked for until at least until that meeting, Alimera CEO Daniel Myers told analysts during a separate call.
"Overall, we were surprised and disappointed with the FDA's decision," Myers said. "We are committed to and, with approximately $39 million in cash as of Sept. 30, have the funds for evaluating our options in the U.S. and pursuing approval in Europe."
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