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This 36-month, open-label Phase 2 study, running concurrently with thepivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in Diabetic MacularEdema), is designed primarily to assess systemic exposure of thecorticosteroid, fluocinolone acetonide (FA), after administration of Iluvienin diabetic macular edema (DME) patients. Secondarily, the study is designedto provide information on the safety and efficacy of Iluvien in a DMEpopulation. A total of 37 subjects were enrolled in this trial, 20 patients onthe low dose (an approximate 0.23 microgram per day dose) of Iluvien, and 17patients on the high dose (an approximate 0.45 microgram per day dose) withthe same inclusion/exclusion criteria as the ongoing Phase 3 FAME Study.
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Iluvien is an intravitreal insert being developed for the treatment ofDME. DME is a disease of the retina, which affects individuals with diabetesand can lead to severe vision loss and blindness. Each Iluvien insert isdesigned to provide a sustained therapeutic effect, up to 24 months for thelow dose and up to 36 months for the high dose. Iluvien is inserted into thepatient's eye with a 25-gauge needle, which allows for a self-sealing wound.This insertion is very similar to an intravitreal injection, a procedurecommonly employed by retinal specialists.
This three-month interim readout from the PK Study indicated 20 percent ofthe low dose patients and 18 percent of the high dose patients showed animprovement in best-corrected visual acuity (BCVA) of 15 letters or greaterfrom baseline. In addition, both the low dose and the high dose of Iluvienresulted in a significant reduction in retinal thickness as compared to thebaseline.
From a safety perspective, no adverse events related to intraocular, orinner eye, pressure were seen in the low dose patients, while 12 percent ofthe high dose patients experienced intraocular pressure increases of greaterthan 30 mmHg. Additionally, the only adverse event related to cataractformation was reported in a patient in the high dose group.
The early readout from this PK Study provides further insight into thedose-response of FA in the treatment of DME. By comparison, Bausch & Lomb'sRetisert(R) (fluocinolone acetonide intravitreal implant), with an initialrelease dose of 0.6 microgram per day, was also studied in a DME population.It demonstrated a significant improvement in visual acuity at one year,comparable to the Iluvien results reported here; however, a lower dose was nottested. Therefore, it has not been determined if Retisert's dosage levelrepresents the lowest efficacious dose for DME.
"We believe this early readout from our PK Study supports our premise thatlower doses of FA delivered by Iluvien will provide visual acuity improvementswhile reducing the risk of ocular side effects commonly associated with theuse of corticosteroids," said Ken Green, Ph.D., chief scientific officer forAlimera.
Data from this open-label study will be evaluated on an ongoing basis withinterim looks at months 3, 6, 12, 18, 24, 30 and 36. Except for the month 12and final month 36 looks, when the database will be fully locked, interimevaluations will be based on unaudited data. The last patient was enrolled inthis study at the end of February 2007.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in theresearch, development and commercialization of prescription ophth
