Alimera Sciences Inc
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NEW FEATURE BUSINESS OF RETINA RETINA ON WALL STREET Alimera Sciences Inc. as having a possible role in dry eye, and the activation of NADPH oxidase in certain pollen grains upon hydration implicates its role in allergic conjunctivitis.” Background: Alimera Sciences was founded in June 2003 as a biopharmaceutical company specializing in Founded: 2003 the research, development, and commercialization of prescription ophthalmic pharmaceuticals. Based: Alpharetta, Georgia The four founders—Dan Myers, Daniel White, Dave Holland, and Mark Testerman—had worked together Number of Employees: 27 and spent the majority of their careers in ophthalmolo- gy at a large pharmaceutical company but felt the big On the Web: www.alimerasciences.com corporate world in general was heading in a direction that they did not want to pursue, Mr. Holland said. Officers: C. Daniel Myers, Co-Founder, Chief “Given our knowledge base and relationships in oph- Executive Officer, and President; David R. Holland, thalmology, we set out to start Alimera. We had enjoyed Co-Founder and Senior Vice President of Sales & our experience in the retinal community with the launch Marketing; Richard S. Eiswirth Jr., Chief Operating of Visudyne (verteporfin, Novartis) and wanted to get Officer, Chief Financial Officer; Susan H. Caballa, back to retina,” Mr. Holland told Retina Today. “Our name Senior Vice President of Regulatory and Medical Alimera derives loosely from ancient Greek with the Affairs; Kenneth Green, PhD, Chief Scientific Officer. intended meaning of 'day of truth'. We wanted a name with meaning and one that would hold us accountable Profile: Alimera Sciences, Inc., is a publicly traded for our actions as we started this venture.” (NASDAQ:ALIM) biopharmaceutical company that In 2004, Alimera introduced Soothe Emollient focuses on the research, development, and commercial- (Lubricant) Eye Drops for dry eyes. Soothe was the first ization of ophthalmic pharmaceuticals for diseases multidose lubricant eye drop to feature Restoryl, a affecting the retina. The company’s product candidates unique lipid restorative that works to reestablish the include Iluvien, an intravitreal insert under investigation lipid layer of tears, promoting sustained moisture reten- to provide a sustained therapeutic effect for up to tion. Soothe was later sold to Bausch + Lomb. 36 months in the treatment of diabetic macular edema Upon gaining support from top-notch venture capital- (DME), as well as wet and dry age-related macular ists, Alimera received funding to get back to the world of degeneration (AMD), and retinal vein occlusion. It retina. “In 2005, we met CDS (Control Delivery Systems, also conducts testing on two classes of nicotinamide now known as pSivida Inc.) and licensed a next-generation adenine dinucleotide phosphate (NADPH) oxidase intravitreal insert from them. Six years later we have com- inhibitors. NADPH oxidase inhibitors have the potential pleted 3 years of clinical trials, submitted our application to prevent reactive oxygen species from becoming to the US Food and Drug Administration (FDA) and excessive, thus managing the development and progres- Medicines and Healthcare products Regulatory Agency sion of diseases of the eye such as geographic atrophy. (MHRA ) and prepared the company for the launch of “In the eye, the inhibition of NADPH oxidase has been Iluvien,” Mr. Holland said. shown to prevent or slow pathology in various models In 2006, Alimera developed and submitted for FDA of ocular disease, including retinal degeneration, retinal approval an application for 0.025% ketotifen fumarate neovascularization, choroidal neovascularization and (Alaway) for the temporary relief of ocular itch. Alaway was uveitis,” according to Alimera. “In addition, the presence approved by the FDA in December of 2006 and was then of NADPH oxidase in corneal epithelial cells implicates it sold along with a potential future line extension to Bausch + 26 IRETINA TODAYIJANUARY/FEBRUARY 2011 RetinaToday.com Lomb, which began marketing Alaway in the spring of 2007. RetinaToday.com In the Pipeline: Alimera’s main product candidate is Iluvien, licensed from pSivida Corp. (Watertown, MA), a 20% profits interest holder. Iluvien is an intravitreal insert for the sustained delivery of fluocinolone ace- RetinaToday.com tonide to the posterior segment. The insert, which is injected with a 25-gauge needle through the pars plana, contains approximately 190 µg of fluocinolone ace- tonide. The insert delivers a dose of approximately 0.2 µg RetinaToday.com per day, with a delivery lifespan of more than 2 years. Alimera filed a New Drug Application (NDA) for Iluvien for the treatment of diabetic macular edema with the FDA on June 29, 2010, including safety and effi- RetinaToday.com cacy data through month 24 of the FAME Study. The FAME study consists of two 36-month phase 3 trials involving 956 participants at 101 sites. On August 30, 2010, Iluvien was granted priority review by the FDA. RetinaToday.com However, on December 23, 2010, the FDA sent Alimera a Compete Response Letter, stating the drug “cannot be approved in its present form.” According to an Alimera news release, the FDA is seeking analyses of safety and RetinaToday.com efficacy data through month 36 of the Iluvien FAME study. Additionally, the FDA asked for further informa- tion relative to its manufacturing facilities. In response, Alimera requested a meeting with the agency to clarify RetinaToday.com the path to regulatory approval and is compiling reports on its month-36 data, and its manufacturing, packaging and sterilization process to provide to the FDA in the first quarter of 2011. Alimera has also sub- RetinaToday.com mitted applications for Iluvien in the United Kingdom, Austria, France, Germany, Italy, Portugal and Spain. “We are pursuing trials with Iluvien in several retinal diseases and we are excited about the potential of our RetinaToday.com NADPH oxidase inhibitor compounds. Our future is ded- icated to moving the back of the eye to the forefront of research and development,” Mr. Holland said. ■ Stock Price as of January 24: $8.973 RetinaToday.com • 52-Week High: $12.70 • 52-Week Low: $6.30 • 1-Year Return: N/A* • Market Cap: 280.638 RetinaToday.com • Dividend Yield: N/A Earnings • Earnings per share for last quarter: -0.22% • Analysts’ earnings per share estimate RetinaToday.com for upcoming quarter: -0.14% • Revenue/sales for last quarter: N/A • Analysts’ revenue/sales estimate for upcoming quarter: N/A RetinaToday.com • P/E (price to earnings) ratio: N/A *company began trading April 22, 2010 RetinaToday.com.