Iluvien Demonstrated Effective Sustained Release of FA, Improved Vision

Iluvien (Alimera Sciences Inc.) provided excellent sustained delivery of fluocinolone acetonide (FA) and significantly improved vision in patients with diabetic macular edema (DME), according to Peter Campochiaro, MD. He presented the results of the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) study at the Angiogenesis 2010: Clinical Trials Conference in Miami.¹ Dr. Campochiaro is a Professor of Ophthalmology and Neurosciences at Johns Hopkins University in Baltimore.

Iluvien, a small intravitreal insert, is being studied as a way to deliver FA to the retina for up to 3 years as a treatment for DME. The insert is 3.5 mm in length and 0.37 mm in diameter and is designed to provide a low daily dose of FA, a nonproprietary corticosteroid. Iluvien is inserted into the patient’s eye using a proprietary inserter with a 25-gauge needle, which creates a self-sealing wound.

Alimera sponsored the FAME study, which consisted of two masked, randomized, multicenter trials including 956 patients in the United States, Canada, Europe, and India. Two doses of Iluvien, a higher dose with an initial release of approximately 0.45 μg per day and a lower dose with an initial release of approximately 0.23 μg per day, were studied.

Of patients treated with a low dose of Iluvien, 26.8% to 30.6% demonstrated improvement in best corrected visual acuity (BCVA) of 15 letters from baseline, and of patients receiving a high dose of Iluvien, 26% to 31.2% demonstrated improvement of 15 or more letters in BCVA from baseline, both at 2 years, the study found.

The results are significant because they “show the primary outcome measure of the percentage of patients who gained 3 or more lines of vision … for the two treatment groups is about 30%, compared with roughly 15% to16% in the sham group,” Dr. Campochiaro said.

Alimera recently reported that it is nearing the end of its phase 3 clinical trials and is likely to be ready for New Drug Application submission to the FDA in the second quarter of 2010. Based on published data, Alimera estimates that there are as many as 300,000 new cases of DME each year, and 1,000,000 people have DME. There are no ophthalmic drug therapies currently approved by the FDA for the treatment of DME.

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Iluvien Demonstrated Effective Sustained Release of FA, Improved Vision

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