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The pilot study will compare two doses of Iluvien (0.23 and 0.45micrograms per day) to sham injection in patients with bilateral geographicatrophy secondary to AMD. The change from baseline in size of geographicatrophy will be assessed over time.
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"The impetus for this study was the results of experiments conducted intwo animal models of retinal degenerations. In both of these models, aminiaturized version of Iluvien demonstrated protective effects on thespontaneous degeneration which occurs in these animals," said Raymond Iezzi,M.D., M.S., Scientific Director, Ligon Research Center of Vision, AssistantProfessor of Ophthalmology, Vitreoretinal Service, Kresge Eye Institute, WayneState University School of Medicine.
"These results were considered compelling enough to warrant a human study,especially for a condition for which there is no approved treatment," addedDr. Iezzi.
Iluvien, a tiny, intravitreal insert, is currently being studied in theFAME Phase III clinical trial as a way to deliver a very low dose offluocinolone acetonide, a corticosteroid, to the retina for up to three yearsas a treatment for diabetic macular edema (DME). An eye care professional,using a proprietary 25-gauge inserter, places Iluvien into the vitreous in aminimally invasive, outpatient procedure.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in theresearch, development and commercialization of prescription ophthalmicpharmaceuticals. Presently the company is focused on diseases affecting theback of the eye, or retina. Its most advanced product candidate isIluvien(TM), which is being developed for the treatment of diabetic macularedema, or DME. DME is a disease of the retina, which affects individuals withdiabetes and can lead to severe vision loss and blindness. Under oneprotocol, enrollment was completed in October 2007 in two Phase 3 pivotaltrials for the use of Iluvien in the treatment of DME conducted across theU.S., Canada, Europe and India, with a combined total enrollment of 956patients.
Alimera also has entered into an exclusive worldwide agreement with EmoryUniversity to explore oxidative stress management -- specifically thereduction of reactive oxygen species (ROS) -- as a treatment strategy forophthalmic diseases. Under this agreement, Alimera has the exclusive option tolicense compounds, which are nicotinamide adenine dinucleotide phosphatereduced form (NADPH) oxidase inhibitors, as potential treatments forconditions such as the dry form of AMD, particularly the late stage of thiscondition known as geographic atrophy. Alimera has exercised its option toacquire a license with respect to one of these classes of NADPH oxidaseinhibitors.
For more information on Alimera Sciences, visithttp://www.alimerasciences.com.
SOURCE Alimera Sciences Inc.
