ATLANTA, June 26 /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 three safety and efficacy results from the first human pharmacokinetic (PK) study of Medidur(TM) FA, which Alimera Sciences intends to market under the tradename Iluvien(TM), if approved by the U.S. Food and Drug Administration.
This 36-month, open-label Phase 2 study, running concurrently with the pivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in diabetic macular edema (DME) patients. Secondarily, the study is designed to provide information on the safety and efficacy of Iluvien in a DME population. A total of 37 subjects were enrolled in this trial, 20 patients on the low dose (an approximate 0.23 microgram per day dose) of Iluvien, and 17 patients on the high dose (an approximate 0.45 microgram per day dose) with the same inclusion/exclusion criteria as the ongoing Phase 3 FAME Study.
Iluvien is an intravitreal insert being developed for the treatment of 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 24 months for the low dose and up to 36 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 three-month interim readout from the PK Study indicated 20 percent of the low dose patients and 18 percent of the high dose patients showed an improvement in best-corrected visual acuity (BCVA) of 15 letters or greater from baseline. In addition, both the low dose and the high dose of Iluvien resulted in a significant reduction in retinal thickness as compared to the baseline.
From a safety perspective, no adverse events related to intraocular, or inner eye, pressure were seen in the low dose patients, while 12 percent of the high dose patients experienced intraocular pressure increases of greater than 30 mmHg. Additionally, the only adverse event related to cataract formation was reported in a patient in the high dose group.
The early readout from this PK Study provides further insight into the dose-response of FA in the treatment of DME. By comparison, Bausch & Lomb's Retisert(R) (fluocinolone acetonide intravitreal implant), with an initial release 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 not tested. Therefore, it has not been determined if Retisert's dosage level represents the lowest efficacious dose for DME.
"We believe this early readout from our PK Study supports our premise that lower doses of FA delivered by Iluvien will provide visual acuity improvements while reducing the risk of ocular side effects commonly associated with the use of corticosteroids," said Ken Green, Ph.D., chief scientific officer for Alimera.
Data from this open-label study will be evaluated on an ongoing basis with interim looks at months 3, 6, 12, 18, 24, 30 and 36. Except for the month 12 and final month 36 looks, when the database will be fully locked, interim evaluations will be based on unaudited data. The last patient was enrolled in this study at the end of February 2007.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently the company is focused on diseases affecting the back of the eye, or retina. Its most advanced product candidate is Iluvien(TM), which is being developed for the treatment of diabetic macular edema, or DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Under one protocol, enrollment was completed in October 2007 in two Phase 3 pivotal trials for the use of Iluvien in the treatment of DME conducted across the U.S., Canada, Europe and India, with a combined total enrollment of 956 patients.
Alimera also has entered into an exclusive worldwide agreement with Emory University to explore oxidative stress management -- specifically the reduction of reactive oxygen species (ROS) -- as a treatment strategy for ophthalmic diseases. Under this agreement, Alimera has the exclusive option to license compounds, which are NADPH (nicotinamide adenine dinucleotide phosphate reduced form) oxidase inhibitors, as potential treatments for conditions such as the dry form of age-related macular degeneration (AMD), particularly the late stage of this condition known as geographic atrophy. Alimera retains the right to use the Medidur(TM) delivery system for two of these compounds, and is also exploring other delivery technologies to apply to these compounds.
|SOURCE Alimera Sciences, Inc.|
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