industry pharmaceutical company health care biotechnology founded 2003 headquarters alpharetta georgia usa key people dan myers ceo rick eiswirth coo cfo susan caballa svp regulatory ken green cso dave holland svp sales and marketing philip ashman svp managing director europe products pharmaceuticals website www.alimerasciences.com 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 edit 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 edit psvida licensor of iluvien references edit atlanta s alimera sciences ipo raises 72m tech journal south april 22 2010 . retrieved november 22 2010 startup alimera sciences lands 26.75 million a round led by intersouth local tech wire july 9 2004 . retrieved november 22 2010 a b bausch & lomb acquires soothe r emollient lubricant eye drops from alimera sciences ; expands product line august 1 2007 . retrieved november 22 2010 bausch & lomb acquires soothe eye drops from alimera sciences optometry and vision science volume 84 issue 9 september 2007 . retrieved november 22 2010 alimera sciences receives otc marketing approval for allergy solution osn super site december 5 2006 . retrieved november 22 2010 alimera shares rise on fda update alim wall street journal august 31 2010 . retrieved november 22 2010 diabetic macular edema drug iluvien gets fda priority review medical news today august 31 2010 . retrieved november 22 2010 fda asks for more data on iluvien for diabetic macular edema . retina today november 2011 . retrieved june 20 2012 alimera sciences inc submits iluvien maa for treatment of diabetic macular edema . reuters . reuters july 8 2010 . retrieved june 20 2012 alimera very close to europe ok for eye drug . pharma times february 29 2012 . retrieved june 20 2012 iluvien gains marketing authorization in portugal for chronic dme . osn supersite june 7 2012 . retrieved june 20 2012 v t e pharmaceutical companies of the united states abbott laboratories acorda therapeutics actavis aderis pharmaceuticals adolor corporation alcon alexion pharmaceuticals alkermes allergan alza amgen amylin pharmaceuticals ariad pharmaceuticals aryx therapeutics avax technologies baxter international biocryst pharmaceuticals biogen biolex biovest biovista bradley pharmaceuticals bristol myers squibb cancervax century pharmaceuticals cephalon ceragenix pharmaceuticals combe incorporated cortex pharmaceuticals cotherix covance covidien cubist pharmaceuticals cutter laboratories cytosport cytrx danco laboratories dnaprint genomics epix pharmaceuticals eli lilly and company elorac endo pharmaceuticals ethicon endo surgery ethicon inc. forest laboratories galena biopharma genvec genentech genta gilead sciences hospira imclone systems institute for oneworld health intercept pharmaceuticals ista pharmaceuticals ivax corporation janssen biotech johnson & johnson kinetic concepts king pharmaceuticals kinray kv pharmaceutical leiner health products mallinckrodt martek biosciences corporation s. e. massengill company mckesson corporation mcneil laboratories melior discovery mentholatum merck & co. miles laboratories mylan myriad genetics naurex nereus pharmaceuticals northwest biotherapeutics norwich pharma services novabay pharmaceuticals nuvelo organon international ortho pharmaceutical ortho mcneil pharmaceutical osi pharmaceuticals ovation pharmaceuticals par pharmaceutical parke davis perrigo pfizer pharmaceutical product development prasco laboratories procter & gamble proteon therapeutics purdue pharma qualitest quark pharmaceuticals regeneron repros therapeutics rib x pharmaceuticals sarepta therapeutics savage laboratories schering plough g. d. searle & company sheffield pharmaceuticals smith kline & french spectrum pharmaceuticals sterling drug tanox tap pharmaceutical products tec laboratories teva pharmaceutical industries tiens biotech group titan pharmaceuticals trevena inc trubion upjohn upsher smith laboratories valeant pharmaceuticals ventria bioscience vertex pharmaceuticals verus pharmaceuticals vion pharmaceuticals inc. viropharma west pharmaceutical services wyeth zonite products corporation list of pharmaceutical companies retrieved from https en.wikipedia.org w index.php title alimera sciences & oldid 696806485 categories companies based in fulton county georgiapharmaceutical companies of the united statespharmaceutical companies established in 2003companies listed on nasdaq navigation menu personal tools not logged intalkcontributionscreate accountlog in namespaces article talk variants views read edit view history more search navigation main pagecontentsfeatured contentcurrent eventsrandom articledonate to wikipediawikipedia store interaction helpabout wikipediacommunity portalrecent changescontact page tools what links hererelated changesupload filespecial pagespermanent linkpage informationwikidata itemcite this page print export create a bookdownload as pdfprintable version languages add links this page was last modified on 26 december 2015 at 02 01 . text is available under the creative commons attribution sharealike license ; 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