NEW YORK (AP) -- In a story Nov. 30 about a regulatory hurdle faced by Alimera Sciences Inc., The Associated Press reported erroneously that the FDA refused to approve Iluvien in November 2012, saying the therapy's potential benefits didn't outweigh its side effects. The FDA refused to approve Iluvien in November 2011, saying that Alimera did not provide sufficient data to support that Iluvien is safe and effective. The FDA did not address costs.
A corrected version of the story is below:
Alimera Sciences shares fall on UK price setback
Alimera Sciences shares fall on latest setback in effort to market retinal disease treatment
NEW YORK (AP) -- Shares of Alimera Sciences Inc. slid Friday following the latest hurdle in its effort to market retinal disease treatment Iluvien.
On Thursday, the U.K.'s top health agency said it's not recommending the drug, a time-release injection that is intended to treat diabetic macular edema, which can cause blurred vision and blindness. Citi analyst Amit Bhalla said the agency indicated that while it did recognize the clinical effectiveness of Iluvien, it's not cost-effective enough to meet its requirements.
Price negotiations are currently under way and could last another two months, the analyst noted. That could make an April launch, as the company had previously hoped for, still a possibility. Citi's Bhalla said U.K. approval is still likely since the stumbling block is only a matter of cost.
The U.S. Food and Drug Administration refused to approve the drug earlier this month, saying that its potential benefits didn't outweigh its side effects.
Alimera is a development-stage company with no products on the market.
Bhalla, who had downgraded the stock from "Buy" after the FDA decision, held onto his "Neutral" rating Friday.
The stock fell 34 cents, or 14.7 percent, to $1.98. It has traded between $1.15 and $4.90 in the past year.
- Pharmaceuticals & Drug Trials