Alimera Sciences Inc is a Delaware corporation incorporated on June 4, 2003. The Company, along with its subsidiaries is engaged in the research, development and commercialization of presecription ophthalmic pharmaceuticals. The Company's commercial product ILUVIEN, was developed to treat diabetic macular edema (DME). DME is a disease of the retina that affects individuals with diabetes and can cause severe vision loss and blindness. ILUVIEN has received marketing authorization in the U.S., Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom and has been recommended for marketing authorization in Poland. ILUVIEN is an intravitreal implant that treats patients by delivering a consistent sub-microgram daily dose of the non-proprietary corticosteroid fluocinolone acetonide (FAc) in the eye, which is sustained through 36 months. ILUVIEN is inserted in a non-surgical procedure employing a device with a 25-gauge needle which allows for a self-sealing wound. In approved European countries, the procedure is performed in a hospital or private clinic setting. In the U.S., the non-surgical procedure is performed in the retinal specialist's office. ILUVIEN, which is non-bioerodable, provides consistent delivery as a result of its constant surface area. This provides a sustained therapeutic effect on DME, and an adverse event profile that is predictable and manageable by a retinal physician. The Company relies on its manufacturers to purchase materials from third-party suppliers necessary to produce ILUVIEN. The Company competes with pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies. The Company's competitors include Roche, Allergan, Regeneron and Bayer. The Company owns six U.S. utility patents, one U.S. design patent and two U.S. patent applications as well as numerous foreign counterparts to many of these patents and patent applications relating to ILUVIEN or the ILUVIEN applicator. The Company licensed two European patents from pSivida directed to its low-dose device and have an application pending directed to its applicator system for ILUVIEN. The manufacture and packaging of pharmaceutical products such as ILUVIEN and any future product candidates are regulated by the FDA and similar foreign regulatory agencies.
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