Alimera’s Phase III DME trials win positive review from DSMB

Alimera Sciences, a biopharmaceutical company engaged in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has reported that an independent Data Safety Monitoring Board has recommended the continuation of two pivotal Phase III clinical trials for the use of Iluvien in the treatment of diabetic macular edema under the current protocol, without change.

The board completed its final review of the currently available safety and efficacy data prior to the readout in October 2009. A Data Safety Monitoring Board (DSMB) provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies.

These clinical trials, known collectively as the Fame Study, consist of two 36-month, doublemasked, randomized, multi-center trials in the US, Canada, Europe and India in support of a planned global registration filing. Safety and efficacy will be assessed after 24 months of follow-up, which will occur in October 2009.

Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME). Each Iluvien insert is designed to provide a sustained therapeutic effect, up to 36 months for the low dose and up to 24 months for the high dose. Iluvien is inserted into the patient’s eye with a 25-gauge needle, which allows for a self-sealing wound, the company said.

Dan Myers, CEO of Alimera, said: Alimera is pleased that the DSMB recommended the continuation of the Fame Study without change. We are looking forward to the last patient, last visit for the 24-month readout scheduled in October 2009.