Alimera Sciences, Inc. (Alimera) is a leading biopharmaceutical company which focuses in the research, development and commercialization of prescription ophthalmic pharmaceuticals. The Company was established on June 4, 2003. It specializes on diseases that affect the back of the eye or retina.
The Company’s advanced product candidate is Iluvien intended for the treatment of diabetic macular edema (DME). By the year 2010, it completed two Phase III pivotal clinical trials which are known as FAMEtm Study. These involve 956 patients in sites across the following areas:
- United States
It is considered as an intravitreal insert for therapeutic effects of up to 36 months in the treatment of DME by delivering sustained sub-microgram levels.Currently, the Company is studying ILUVIEN through three Phase II clinical trials for the treatment of the dry form of age-related macular degeneration (AMD), the wet form of AMD and retinal vein occlusion (RVO). Moreover, the Company is also conducting testing on two classes of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase inhibitors.
Its Fame Study was specifically tailored for the assessment of the safety and efficacy of ILUVIEN in patients with DME involving the center of the macula, and who had at least one prior macular laser treatment 12 weeks or more before study entry. It follows a certain criteria designed to select DME patients with BCVA between 20/50 and 20/400.
In conducting the study, the Company randomly assigned patients participating in its FAME Study to one of three groups at a ratio of 2:2:1. These groups are composed of one group receiving a low dose of ILUVIEN and another group receiving a high dose of ILUVIEN.
The NADPH oxidase is found in almost every tissue type and there is a significant amount of scientific literature associating NADPH oxidase activation with many systemic and ocular conditions. In the eye, this substance is inhibited and will consequently lead to the prevention of various models of ocular disease, including retinal degeneration, retinal neovascularization, choroidal neovascularization and uveitis.
NADPH oxidase when present in corneal epithelial cells shows that there is a possibility of having dry eyes, and the activation of NADPH oxidase in certain pollen grains upon hydration implicates its role in allergic conjunctivitis.
The Company’s competitors include Allergan, Inc., Alcon, Inc., Genentech Inc., Eyetech, Inc., Regeneron, Inc., MacuSight, Inc., Thrombogenics NV. and Novagali Pharma S.A.
Alimera Sciences Inc. (NASDAQ: ALIM) 52 week: 1.09 – 9.28 Mkt cap: 87.05M Shares: 31.43MTags: ALIM, ALIM stock, Alimera, Alimera Sciences, Alimera Sciences Inc., Stocks to watch