Alimera Sciences

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Alimera Sciences Inc.
Company typePublic
Nasdaq: ALIM
Russell Microcap Index component
Industry
Founded2003; 21 years ago (2003)
HeadquartersAlpharetta, Georgia, US
Key people
Rick Eiswirth, (president and CEO)
ProductsPharmaceuticals
RevenueIncrease $54.1 Million(2019)[1]
Websitewww.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.

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

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. ^ a b 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.
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