Positive Results with Intravitreal Insert Reported for DME Treatment

Investigators for the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) trial reported positive results from two phase 3 trials of Iluvien (Alimera Sciences, Inc., Alpharetta, GA), an extended release, nonerodable injectable fluocinolone intravitreal implant. According to the company, each Iluvien insert delivers sustained submicrogram levels of fluocinolone acetonide and is designed to provide a therapeutic effect for up to 36 months.

More than 950 patients participated in the multicenter, randomized, double-masked trial, according to a company news release. Patients were assigned to either receive a low dose of Iluvien, a high dose of Iluvien, or a control group. Researchers reported that 26.8% to 30.6% of patients who received a low dose of Iluvien and 26% to 31.2% of patients who received a high dose had improved best corrected visual acuity of 15 letters from baseline at 2 years.

From a safety perspective, intraocular pressure increases of 30 mm Hg or greater at any time point were seen in 16.3% of the low-dose patients and 21.6% of the high-dose patients. Over the 24-month period, 2.1% of low-dose patients and 5.1% of high-dose patients underwent a trabeculectomy.

Based on these results, Alimera said it plans to file a new drug application for the low dose of Iluvien for the treatment of diabetic macular edema (DME) in the second quarter of 2010.

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Positive Results with Intravitreal Insert Reported for DME Treatment

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