Alimera Sciences, Inc. (NASDAQ: ALIM), Alpharetta, GA, have announced the receipt of a Complete Response Letter (CRL) from the FDA for their New Drug Application (NDA) for Iluvien, a corticosteroid implant treatment for vision impairment associated with chronic DME considered insufficiently responsive to currently available therapies. The letter, the third to issue from the FDA in respect of Iluvien, highlights the risk and safety profiles of the drug and states that no approval can be provided for the drug’s current form. The FDA is understood to be requesting a further clinical trial, together with 12-month follow-up data, to address certain clinical and statistical deficiencies. The company reported that the FDA may facilitate a meeting in Jan 2014 to address the deficiencies and provide advice on the potential treatment of a specific patient population in which the benefits of the drug might outweigh the risks.
Alimera announces receipt of Complete Response Letter for Iluvien from FDA
- by swdadmin