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news.Alimera Sciences, a developer of prescription ophthalmic pharmaceuticals, has reported that after completing its review of safety and efficacy data currently available, an independent data safety monitoring board has again recommended that the two pivotal Phase III clinical trials for the use of Iluvien in the treatment of diabetic macular edema continue under the current protocol, without change.
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These clinical trials, known collectively as the Fame study, consist of two double masked, randomized, multi-center trials that are following 956 patients in the US, Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after 24 months of follow-up.
Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME) and is said to be 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.
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.
Dan Myers, Alimera’s CEO, said: “The DSMB’s recommendation to continue the Fame study without change keeps the development for Iluvien on track for regulatory submissions in early 2010.”