ready 4 a run, page-8

FDA requested this study , i see this as a positive overwise they wouldn't have bothered if approval for ILUVIEN wasn't coming.





On November 3, 2011, Alimera Sciences, Inc. (“Alimera”), pSivida Corp.’s licensee with respect to ILUVIEN®, issued a press release providing the following information:

“In September 2011, [Alimera] enrolled its first patient in a physician utilization study of its intended commercial inserter for ILUVIEN. The study was initiated in response to a request from the FDA to ensure physicians have a proper understanding of the instructions for inserting the ILUVIEN micro insert into patient eyes. [Alimera] has enrolled 54 patient eyes to date in this study, evaluating the safety and utility of the commercial version of the inserter for ILUVIEN, and is targeting to enroll 100 patient eyes before commercial launch.”

Data from this study may be required by the FDA for its consideration of the approval of ILUVIEN.