Iluvien Update 4: FDA Turns Down Alimera’s NDA for Approval of Iluvien Again
Alimera again received bad news from the FDA on its application for approval of Iluvien. In a letter (a CRL or complete response letter), the FDA said that questions remained based on the data previously submitted, about the adverse reactions shown by Iluvien in the FAME Study (risk of cataracts and raised IOPs) and that these were not offset by the benefits demonstrated.