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Two-year results of FAME study announced

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WATERTOWN, Mass. — Combined analysis of patients enrolled in two phase 3 clinical trials demonstrated efficacy of a steroid implant used to treat diabetic macular edema.

Results of the 2-year trials have prompted Alimera Sciences, a licensee of the Iluvien (sustained release fluocinolone acetonide) device manufactured by pSivida, to file for a new drug application for regulatory approval of low-dose Iluvien in the second quarter of this year, pSivida announced in a press release.

In the FAME (Fluocinolone acetonide in diabetic macular edema) study, 28.7% of patients treated with low-dose Iluvien and 28.6% of patients treated with a high dose gained at least 15 letters, compared with 16.2% of patients in the sham group. According to the release, more than 50% of patients treated with low-dose Iluvien low gained at least five letters at 24 months, and more than 75% required only a single administration of the device.

However, patients treated in the low-dose group had a higher reported rate of increased IOP, glaucoma and cataract. The results were announced at the Angiogenesis 2010 meeting.

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