Alimera Sciences

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.^[1]

History

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.^[2]

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,^[3] 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.^[4]

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^[5] and was sold along with a potential future line extension to Bausch & Lomb, which began marketing Alaway in Spring 2007.^[3]

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.^[6] 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.^[7] 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.^[8] 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.

In July 2010, a Marketing Authorization Application (MAA) for ILUVIEN was submitted to seven European countries via the Decentralized Regulatory Procedure (DCP) with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) serving as the Reference Member State (RMS). The six Concerned Member States (CMS) include Austria, France, Germany, Italy, Spain and Portugal.^[9]

In February 2012, based on a consensus arrived upon by the RMS and the CMS, the MHRA issued its Final Assessment Report that ILUVIEN is approvable. The company was tasked with seeking individual marketing authorizations in each of the seven countries.^[10] As of January 2014, ILUVIEN has been approved in Austria, France, Germany, Portugal, Spain, and the U.K. for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In April 2013, Alimera began selling ILUVIEN in Germany and the UK, and intends to begin selling in France in 2014. ILUVIEN is available through the U.K. National Health Service. Alimera has filed with the Medicines and Healthcare Products Regulatory Agency in the U.K. as the Reference Member State for 10 additional European Union (EU) country approvals through the Mutual Recognition Procedure.^[11]

See also

• pSvida, licensor of Iluvien

References