Alimera Sciences

Last updated
Alimera Sciences Inc.
Company type Public
Nasdaq:  ALIM
Russell Microcap Index component
Industry
Founded2003;21 years ago (2003)
Headquarters Alpharetta, Georgia, US
Key people
Rick Eiswirth, (president and CEO)
Products Pharmaceuticals
RevenueIncrease2.svg $54.1 Million(2019) [1]
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.

Contents

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. [3]

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, [4] 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. [5]

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 [6] and was sold along with a potential future line extension to Bausch & Lomb, which began marketing Alaway in spring 2007. [4]

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. [7] The company submitted the Iluvien new drug application to the FDA in June 2010 and was granted priority review in August 2010. [8] 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. [9] 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. [10]

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. [11] 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. [12]

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. [13]

See also

Related Research Articles

<span class="mw-page-title-main">Diabetic retinopathy</span> Medical condition

Diabetic retinopathy, is a medical condition in which damage occurs to the retina due to diabetes mellitus. It is a leading cause of blindness in developed countries.

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.

<span class="mw-page-title-main">Macular edema</span> Medical condition

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.

Bevacizumab, sold under the brand name Avastin among others, is a monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, ovarian cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).

<span class="mw-page-title-main">Triamcinolone acetonide</span> Medicinal chemical compound, steroid

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.

<span class="mw-page-title-main">Intravitreal administration</span>

Intravitreal 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.

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<span class="mw-page-title-main">Fluocinolone acetonide</span> Corticosteroid anti-inflammatory drug

Fluocinolone acetonide is a 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 name Synalar. A typical dosage strength used in dermatology is 0.01–0.025%. One such cream is sold under the brand name Flucort-N and includes the antibiotic neomycin.

<span class="mw-page-title-main">Intermediate uveitis</span> Medical condition

Intermediate uveitis is a form of uveitis localized to the vitreous and peripheral retina. Primary sites of inflammation include the vitreous of which other such entities as pars planitis, posterior cyclitis, and hyalitis are encompassed. Intermediate uveitis may either be an isolated eye disease or associated with the development of a systemic disease such as multiple sclerosis or sarcoidosis. As such, intermediate uveitis may be the first expression of a systemic condition. Infectious causes of intermediate uveitis include Epstein–Barr virus infection, Lyme disease, HTLV-1 virus infection, cat scratch disease, and hepatitis C.

<span class="mw-page-title-main">Bromfenac</span> Chemical compound

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.

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<span class="mw-page-title-main">Vision disorder</span> Medical condition

A vision disorder is an impairment of the sense of vision.

<span class="mw-page-title-main">Macular telangiectasia</span> Disease of the retina affecting central 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.

<span class="mw-page-title-main">Besifloxacin</span> Chemical compound

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<span class="mw-page-title-main">ISTA Pharmaceuticals</span> US-based pharmaceutical company

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<span class="mw-page-title-main">Vitreomacular adhesion</span> Human medical condition

Vitreomacular adhesion (VMA) is a human medical condition where the vitreous gel of the human eye adheres to the retina in an abnormally strong manner. As the eye ages, it is common for the vitreous to separate from the retina. But if this separation is not complete, i.e. there is still an adhesion, this can create pulling forces on the retina that may result in subsequent loss or distortion of vision. The adhesion in of itself is not dangerous, but the resulting pathological vitreomacular traction (VMT) can cause severe ocular damage.

<span class="mw-page-title-main">Lifitegrast</span> Chemical compound

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<span class="mw-page-title-main">Faricimab</span> Medication for macular degeneration

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<span class="mw-page-title-main">Intravitreal injection</span> Method of administration of drugs into the eye by injection with a fine needle

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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.

References

  1. "Alimera Sciences Revenue 2009-2021 | ALIM".
  2. Atlanta's Alimera Sciences IPO raises $72M Archived 2011-05-29 at the Wayback Machine , Tech Journal South, April 22, 2010. Retrieved November 22, 2010
  3. Startup Alimera Sciences Lands $26.75 Million 'A' Round, Led by Intersouth, Local Tech Wire, July 9, 2004. Retrieved November 22, 2010
  4. 1 2 Bausch & Lomb Acquires Soothe(R) Emollient (Lubricant) Eye Drops from Alimera Sciences; Expands Product Line, August 1, 2007. Retrieved November 22, 2010
  5. Bausch & Lomb Acquires Soothe Eye Drops from Alimera Sciences, Optometry and Vision Science, Volume 84, Issue 9, September 2007. Retrieved November 22, 2010
  6. Alimera Sciences receives OTC marketing approval for allergy solution, OSN Super Site, December 5, 2006. Retrieved November 22, 2010
  7. Alimera Shares Rise On FDA Update [ALIM, The Wall Street Journal , August 31, 2010. Retrieved November 22, 2010
  8. Diabetic Macular Edema Drug Iluvien Gets FDA Priority Review, Medical News Today, August 31, 2010. Retrieved November 22, 2010
  9. "FDA Asks for More Data on Iluvien for Diabetic Macular Edema". Retina Today, November 2011. Retrieved June 20, 2012
  10. "Alimera Sciences Inc Submits Iluvien MAA For Treatment Of Diabetic Macular Edema". Reuters.[ permanent dead link ] Reuters, July 8, 2010. Retrieved June 20, 2012
  11. "Alimera very close to Europe OK for eye drug". Archived from the original on 2014-02-22. Retrieved 2012-07-13. Pharma Times, February 29, 2012. Retrieved June 20, 2012
  12. "Iluvien gains marketing authorization in Portugal for chronic DME".OSN SuperSite, June 7, 2012. Retrieved June 20, 2012
  13. "Alimera's Iluvien receives positive funding recommendation". www.healio.com. June 20, 2019. Retrieved 2019-10-21.