Alimera Sciences, Inc. was a

biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...

sales company based in

Alpharetta, Georgia Alpharetta is a city in northern Fulton County, Georgia, United States, and part of the Atlanta metropolitan area. As of the 2020 U.S. census, Alpharetta's population was 65,818; in 2010, the population had been 57,551. History In the 1830s, ...

that specialized in the commercialization and sales of prescription ophthalmic

pharmaceutical Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...

s. The company's main selling focus was on diseases affecting the back of the eye, or

retina The retina (; or retinas) is the innermost, photosensitivity, light-sensitive layer of tissue (biology), tissue of the eye of most vertebrates and some Mollusca, molluscs. The optics of the eye create a focus (optics), focused two-dimensional ...

. In September, 2024, ANI Pharmaceuticals, Inc. announced that it had completed its purchase of the company.

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 Novartis AG is a Swiss multinational corporation, multinational pharmaceutical company, pharmaceutical corporation based in Basel, Switzerland. Novartis is one of the largest pharmaceutical companies in the world and was the eighth largest by re ...

Ophthalmics following a merger. In 2004, Alimera Sciences introduced Soothe emollient (lubricant)

eye drops ''Eye Drops'' is a television program on TechTV that showcased short computer animation movies and clips made using off the shelf 3D animation software. The show claimed to showcase all different types of animation, but only a very small number ...

for people with dry eyes. Soothe was the first lubricant eye drop to feature Restoryl,Bausch & Lomb Acquires Soothe(R) Emollient (Lubricant) Eye Drops from Alimera Sciences; Expands Product Line
August 1, 2007. Retrieved November 22, 2010 a lipid restorative that works to re-establish the

lipid Lipids are a broad group of organic compounds which include fats, waxes, sterols, fat-soluble vitamins (such as vitamins A, D, E and K), monoglycerides, diglycerides, phospholipids, and others. The functions of lipids include storing ...

(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 from 1996 to 2001. Soothe was sold to Bausch & Lomb in August 2007. In 2006, Alimera Sciences developed and submitted for U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

approval an application for a prescription to

over-the-counter drug Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid pres ...

switch of 0.025%

ketotifen Ketotifen is an antihistamine medication and a mast cell stabilizer used to treat allergic conditions such as conjunctivitis, asthma, and urticaria (hives). Ketotifen is available in ophthalmic (eye drops or drug-eluting contact lenses) and o ...

fumarate, for the temporary relief of ocular itch. This product, Alaway, was approved by the Food and Drug Administration in December 2006 and was sold along with a potential future line extension to Bausch & Lomb, which began marketing Alaway in spring 2007. The company's licensed product, Iluvien, is a sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide for 36 months. Alimera conducted two phase 3 clinical trials for Iluvien involving 956 patients in sites across the

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Canada Canada is a country in North America. Its Provinces and territories of Canada, ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, making it the world's List of coun ...

Europe Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east ...

and

India India, officially the Republic of India, is a country in South Asia. It is the List of countries and dependencies by area, seventh-largest country by area; the List of countries by population (United Nations), most populous country since ...

to assess the efficacy and safety of Iluvien at two dose levels. The company submitted the Iluvien

new drug application The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...

to the FDA in June 2010 and was granted priority review in August 2010. In December 2010, November 2011, and October 2013 the Food and Drug Administration issued complete response letters stating that it was unable to approve a new drug application for Iluvien. Alimera met with the Food and Drug Administration 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 for Iluvien was submitted to seven European countries via the Decentralized Regulatory Procedure with the United Kingdom’s Medicines and Healthcare products Regulatory Agency serving as the Reference Member State. The six Concerned Member States include Austria, France, Germany, Italy, Spain and Portugal. In February 2012, based on a consensus arrived upon by the Reference Member State and the Concerned Member States, the Medicines and Healthcare products Regulatory Agency issued its Final Assessment Report that Iluvien is approvable. The company was tasked with seeking individual marketing authorizations in each of the seven countries. 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 diabetic macular edema considered insufficiently responsive to available therapies. In April 2013, Alimera began selling Iluvien in Germany and the UK, and intended to begin selling in France in 2014. Iluvien is available through the U.K. National Health Service. Alimera 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. In 2019, the U.K.'s

National Institute for Health and Care Excellence The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the Department of Health and Social Care (United Kingdom), Department of Health and Social Care. As the national health technolog ...

has recommended funding for Iluvien as treatment for noninfectious posterior uveitis. The drug has also been indicated for and funded for the treatment of diabetic macular edema in the United Kingdom.

References

{{Authority control Companies based in Fulton County, Georgia Pharmaceutical companies of the United States Pharmaceutical companies established in 2003 Companies formerly listed on the Nasdaq Health care companies based in Georgia (U.S. state) 2024 mergers and acquisitions

History

See also

References