It appears to be tough rise ahead of Alimera Sciences, as it has got refusal from the Food and Drug Administration for its drug Iluvien. Meant for those who are suffering from diabetic macular edema, or DME, the drug is told to have been found unsafe to be recommended for clinical application.
As the news hit the markets across the world, the shares were told to have dropped by 73% to $1.96 at the close in New York, which has brought shock to one and all related with the drug. Markets experts are of the view that this decision by the FDS could put the future of the makers under clouds in the time to come. Even it is known that the company must be finding it difficult to sustain the amount if investment required for evaluating the future options of the drug in the US market.
It was also told that the company was notified in December about the insufficient proof in favor of the drug, but it reapplied in May with the demanded extra 12 months of clinical trial data. The FDA was of the firm view that the drug has failed to convince that it’s safe enough for patients.
Being the first product of Georgia-based Alimera, the drug is told to have the capacity to release steroid fluocinolone acetonide in small fraction for three years. The company was of the views that if the FDA would have given them the green signal, sales could have crossed the mark of $900 million, but it seems that now there are feeble expectations left for the company.
Reacting to the news, Dan Myers, president and chief executive officer of Alimera, said “We are surprised and disappointed with the FDA’s decision on our application to market Iluvien in the U. S. to patients with this devastating disease”. Even the company has expressed that it would try to work out for approval in European market now.
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