FDA declines to approve Alimera’s eye drug, shares tank

The U.S. Food and Drug Administration declined to approve Alimera Sciences Inc’s experimental drug to treat retinal swelling in its current form, sending the biopharmaceutical company’s shares down 41 percent in after-market trade.

The Alpharetta, Georgia-based company said the FDA has not asked for any new clinical trials, but requires more safety and efficacy data from the company’s two late-stage trials to further assess the relative benefits and risks of the drug.

Alimera is developing the drug Iluvien in partnership with pSivida Corp to treat diabetic macular edema—the most prevalent cause of moderate vision loss in patients with diabetes.

The FDA has also asked for more information on controls and specifications concerning the manufacturing, packaging and sterilization of the drug, the company said.

The company said it is currently compiling these data.

The FDA found deficiencies in current good manufacturing practices (cGMP) during its facility inspections of two of Alimera’s third-party manufacturers in August and September, the company said.

Alimera shares, which have gained 39 percent since its drug got a priority review in end-August, were down 41 percent at $6.66 in extended-trade. They closed at $11.22 on Thursday on Nasdaq.

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(Reuters)