Alimera Sciences
Alimera Sciences headquarters in Alpharetta
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| Public (NASDAQ: ALIM) | |
| Industry | Pharmaceutical company, health care, biotechnology |
| Founded | 2003 |
| Headquarters | Alpharetta, Georgia, USA |
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Key people
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Dan Myers, CEO Rick Eiswirth, COO, CFO Susan Caballa, SVP Regulatory Ken Green, CSO Dave Holland, SVP, Sales and Marketing Philip Ashman, SVP, Managing Director Europe |
| Products | Pharmaceuticals |
| Website | www.alimerasciences.com |
Alimera Sciences, Inc. is a biopharmaceutical company based in Alpharetta, Georgia that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Their main focus is on diseases affecting the back of the eye, or retina.
Alimera was founded in June 2003 by Dan Myers, Daniel White, Dave Holland and Mark Testerman. Three of the founders were previously part of Ciba Vision Ophthalmics, which was renamed Novartis Ophthalmics following a merger.
In 2004, Alimera Sciences introduced Soothe Emollient (Lubricant) Eye Drops for people with dry eyes. Soothe was the first lubricant eye drop to feature Restoryl, a lipid restorative that works to re-establish the lipid (oily) layer of tears, promoting sustained moisture retention. Soothe was a mineral oil in water emulsion developed by Chris Brancewicz (then at Clarkson University) for Ocular Research of Boston during 1996-2001. Soothe was sold to Bausch & Lomb in August 2007.
In 2006, Alimera Sciences developed and submitted for U.S. Food and Drug Administration (FDA) approval an application for a prescription to over-the-counter drug switch of 0.025% ketotifen fumarate, for the temporary relief of ocular itch. This product, Alaway, was approved by the FDA in December 2006 and was sold along with a potential future line extension to Bausch & Lomb, which began marketing Alaway in Spring 2007.
Alimera conducted two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN at two dose levels. ILUVIEN is a sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for 36 months. The company submitted the ILUVIEN New Drug Application (NDA) to the FDA in June 2010 and was granted priority review in August 2010. In December 2010, November 2011, and October 2013 the FDA issued Complete Response Letters (CRL) stating that it was unable to approve a NDA for ILUVIEN. Alimera met with the FDA in December 2013 and entered into labeling discussions. As a result, the company plans to refile with the FDA in early 2014.
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