Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study

Jun 26, 2008, 01:00 ET from Alimera Sciences, Inc.

    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
     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
     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.