Industry | |
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Founded | 2003 |
Headquarters | Alpharetta, Georgia, US |
Key people | Rick Eiswirth, (president and CEO) |
Products | Pharmaceuticals |
Revenue | $54.1 Million(2019) [1] |
Owner |
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Website | www.alimerasciences.com |
Alimera Sciences, Inc. is a biopharmaceutical sales company based in Alpharetta, Georgia that specializes in the commercialization and sales of prescription ophthalmic pharmaceuticals. The company's main selling focus is on diseases affecting the back of the eye, or retina. [2] The company is the licensee for Iluvien, a fluocinolone acetonide intravitreal implant.
In September, 2024, ANI Pharmaceuticals, Inc. announced that it had completed its purchase of the company. [3]
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. [4]
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, [5] 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 from 1996 to 2001. Soothe was sold to Bausch & Lomb in August 2007. [6]
In 2006, Alimera Sciences developed and submitted for U.S. Food and Drug Administration 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 Food and Drug Administration in December 2006 [7] and was sold along with a potential future line extension to Bausch & Lomb, which began marketing Alaway in spring 2007. [5]
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 United States, Canada, Europe and India to assess the efficacy and safety of Iluvien at two dose levels. [8] The company submitted the Iluvien new drug application to the FDA in June 2010 and was granted priority review in August 2010. [9] 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. [10] 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.[ needs update ]
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. [11]
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. [12] 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. [13]
In 2019, the U.K.'s National Institute for Health and Care Excellence 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. [14]
Bausch & Lomb is an American-Canadian eye health products company based in Vaughan, Ontario, Canada. It is one of the world's largest suppliers of contact lenses, lens care products, pharmaceuticals, intraocular lenses, and other eye surgery products. The company was founded in Rochester, New York, in 1853 by optician John Bausch and cabinet maker turned financial backer Henry Lomb. Until its sale in 2013, Bausch + Lomb was one of the oldest continually operating companies in the United States.
The National Eye Institute (NEI) is part of the U.S. National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. The mission of NEI is "to eliminate vision loss and improve quality of life through vision research." NEI consists of two major branches for research: an extramural branch that funds studies outside NIH and an intramural branch that funds research on the NIH campus in Bethesda, Maryland. Most of the NEI budget funds extramural research.
Macular edema occurs when fluid and protein deposits collect on or under the macula of the eye and causes it to thicken and swell (edema). The swelling may distort a person's central vision, because the macula holds tightly packed cones that provide sharp, clear, central vision to enable a person to see detail, form, and color that is directly in the centre of the field of view.
Bausch Health Companies Inc. is an American-Canadian multinational specialty pharmaceutical company based in Laval, Quebec, Canada. It develops, manufactures and markets pharmaceutical products and branded generic drugs, primarily for skin diseases, gastrointestinal disorders, eye health and neurology. Bausch Health owns Bausch & Lomb, a supplier of eye health products. Bausch Health's business model is primarily focused on acquiring small pharmaceutical companies and then sharply increasing the prices of the drugs these companies sell.
Triamcinolone acetonide, sold under the brand name Kenalog among others, is a synthetic corticosteroid medication used topically to treat various skin conditions, to relieve the discomfort of mouth sores, and by injection into joints to treat various joint conditions. It is also injected into lesions to treat inflammation in some parts of the body, particularly the skin. In nasal spray form, it is used to treat allergic rhinitis. It is used for the treatment of macular edema associated with uveitis. It is a more potent derivative of triamcinolone, and is about eight times as potent as prednisone.
Intravitreal administration is a route of administration of a drug, or other substance, in which the substance is delivered into the vitreous humor of the eye. "Intravitreal" literally means "inside an eye". Intravitreal injections were first introduced in 1911 when Ohm gave an injection of air into the vitreous humor to repair a detached retina. In the mid-1940s, intravitreal injections became a standard way to administer drugs to treat endophthalmitis and cytomegalovirus retinitis.
Ranibizumab, sold under the brand name Lucentis among others, is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that is approved to treat the "wet" type of age-related macular degeneration, diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.
Fluocinolone acetonide is a fluorinated corticosteroid primarily used in dermatology to reduce skin inflammation and relieve itching. It is a synthetic hydrocortisone derivative. The fluorine substitution at position 9 in the steroid nucleus greatly enhances its activity. It was first synthesized in 1959 in the Research Department of Syntex Laboratories S.A. Mexico City. Preparations containing it were first marketed under the brand name Synalar.
Pegaptanib sodium injection is an anti-angiogenic medicine for the treatment of neovascular (wet) age-related macular degeneration (AMD). It was discovered by NeXstar Pharmaceuticals and licensed in 2000 to EyeTech Pharmaceuticals, now OSI Pharmaceuticals, for late stage development and marketing in the United States. Gilead Sciences continues to receive royalties from the drugs licensing. Outside the US pegaptanib is marketed by Pfizer. Approval was granted by the U.S. Food and Drug Administration (FDA) in December 2004.
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) marketed in the US as an ophthalmic solution by ISTA Pharmaceuticals for short-term, local use. Prolensa and Bromday are the once-daily formulation of bromfenac, while Xibrom was approved for twice-daily administration. In the European Union, the brand name is Yellox. Bromfenac is indicated for the treatment of ocular inflammation and pain after cataract surgery.
Aflibercept, sold under the brand names Eylea and Zaltrap, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals.
Bepotastine is a 2nd generation antihistamine. It was approved in Japan for use in the treatment of allergic rhinitis and urticaria/pruritus in July 2000, and January 2002, respectively. It is marketed in the United States as an eye drop under the brand name Bepreve, by ISTA Pharmaceuticals, a subsidiary of Bausch + Lomb.
A vision disorder is an impairment of the sense of vision.
Macular telangiectasia is a condition of the retina, the light-sensing tissue at the back of the eye that causes gradual deterioration of central vision, interfering with tasks such as reading and driving.
ISTA Pharmaceuticals, Inc., was a US-based pharmaceutical company that specialized in ophthalmic pharmaceutical products and discovers, develops, and markets therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. ISTA was acquired by Bausch & Lomb, an eye care company, on March 26, 2012. Under the deal, Bausch & Lomb have agreed to pay $9.10 per share for ISTA, bringing the total value of the acquisition to $500 million. In 2012, Valeant Pharmaceuticals withdrew its $360 million offer.
Lifitegrast, sold under the brand name Xiidra, is a medication for the treatment of signs and symptoms of dry eye, a syndrome called keratoconjunctivitis sicca. Lifitegrast reduces inflammation by inhibiting inflammatory cell binding. It is often used in conjunction with ciclosporin for dry eye treatment including meibomian gland dysfunction and inflammatory dry eye.
Latanoprostene bunod, sold under the brand name Vyzulta, is an ophthalmic medication used for the reduction of intraocular pressure in people with open-angle glaucoma or ocular hypertension. It targets the trabecular meshwork directly. It is a prostaglandin analog.
Faricimab, sold under the brand name Vabysmo, is a monoclonal antibody used for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Faricimab is the first bispecific monoclonal antibody to target both vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2). By targeting these pathways, faricimab stabilizes blood vessels in the retina. It is given by intravitreal injection by an ophthalmologist.
Intravitreal injection is the method of administration of drugs into the eye by injection with a fine needle. The medication will be directly applied into the vitreous humor. It is used to treat various eye diseases, such as age-related macular degeneration (AMD), diabetic retinopathy, and infections inside the eye such as endophthalmitis. As compared to topical administration, this method is beneficial for a more localized delivery of medications to the targeted site, as the needle can directly pass through the anatomical eye barrier and dynamic barrier. It could also minimize adverse drug effects on other body tissues via the systemic circulation, which could be a possible risk for intravenous injection of medications. Although there are risks of infections or other complications, with suitable precautions throughout the injection process, chances for these complications could be lowered.
Conbercept, sold under the commercial name Lumitin, is a novel vascular endothelial growth factor (VEGF) inhibitor used to treat neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The anti-VEGF was approved for the treatment of neovascular AMD by the China State FDA (CFDA) in December 2013. As of December 2020, conbercept is undergoing phase III clinical trials through the U.S. Food and Drug Administration’s PANDA-1 and PANDA-2 development programs.