Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien...( ATLANTA Oct. 1 /- Alimera Science...),Health

ATLANTA, Oct. 1 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported the interim month six safety and efficacy results from the first human pharmacokinetic (PK) study of Iluvien(TM).

Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME). DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. 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. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.

This 36-month, open-label, Phase 2 PK study, running concurrently with the pivotal Phase 3 FAME(TM) Study of Iluvien (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide, after administration of Iluvien in patients with DME. Secondarily, the PK study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 subjects were enrolled in the PK study, 20 patients on the low dose of Iluvien (an approximate 0.23 micrograms per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45 micrograms per day dose).

The six-month interim readout from the PK study showed 18 percent of the high dose patients had an improvement in best corrected visual acuity (BCVA) of 15 letters or greater over baseline. This is consistent with the three- month readout. The percentage of low dose patients that had an improvement in BCVA of 15 letters or greater from baseline decreased from
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