Bmsch+Loml>Sul:mitsNewDrugApplicationfiit0noe-DailyPROI.IDfSA“‘toT:eatOculxInflannnationandPainFollowirigCatanctSurgay
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`Home > ._.> Newsroom ) 2012 archive ) Bausch + Lomb Submits New Drug Application For Once—Daily PROLENSA“‘ To
`Treat Ocular Inflammation And Pain Following Cataract Surgery
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`E R55
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`FOR RELEASE 6/18/2012, Monday
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`Bausch + Lomb Submits New Drug Application for Once-Daily PROLENSA"
`l 2013 Archive
`to Treat Ocular Inflammation and Pain Following Cataract Surgery
`n 2012 Archive
`MADISON, N_J_ — Bausch + Lomb, he global eye health company, announced today that it has submitted a New Dmg
`H 20“ Archive
`Application (NDA) to he U.S. Food and Drug Administration (FDA) seeking approval for PROLENSA" (bromfenac
`ophthalmic solution), a once—daily topical nonsteroidal anti—in1lammatory compound for the treatment of ocular inflammation T
`and pain following cataract surgery. PROLENSA, developed by recently acquired ISTA Phannaceu icals, lnc., incorporates a
`n 2010-Al’-Chile
`kywer concentra ion of bromfenac han the currently available oncedaily BROMDAY"‘ (bromfenac ophthalmic solution) 0.09
`n jm
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`— R
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`n 2008 Archive
`n 2001 Archive
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`percent, in a new formulation,
`‘The new, op inized formula ion used for PROLENSA allows for a lower concentration of bronifenac, while maintaining the
`convenience of once-daiy use cunen ly prescribed with BROMDAY,‘ stated Calvin Roberts, M.D., executive vice president,
`chief medical officer, Bausch + Lomb. A patent for PROLENSA's formulation and method of use, expiring in 2025, was
`recently issued to the Iicensor, Senju Phamiaceutical Co. Ltd_, by the United States Patent and Trademark Oflice.
`
`‘The PROLENSA filing is an important step towards bringing safe, effective and meaningful medical advances to medical
`professionals and heir pa ients,' said Marvin Ganett, vice president of U.S. Regulatory Affairs, Quaity Assurance and
`Compliance, Bausch + Lomb. ‘It's also a tirriely example of the progress we continue to make on critical D&R programs as
`we work to bring together the best of ISTA Phannaceuticals and Bausch + Lornb.'
`About PROLENSA"
`PROLENSA (bromfenac ophthalmic solution) is being developed as a oncedaily topical nonsteroidal anti—intlarnmatory
`compound for the treatment of ocular iitlammation and pair following cataract surgery. PROLENSA incorporates a lower
`concentration of brornfenac than he company's current orrcedaily NSAID, BROMDAY (bromfenac ophthalmic solution) 0.09
`percent in a new formulation. From 2005 until 2011, ISTA Pharmaceuticals, Inc. marketed XIBROM (brorrifenac ophthalmic
`solution)® 0.09 percent in the U_S_ for twice-daily use for the treatment of postoperative inflammation and he reduction of
`ocular pain in patients who have undergone cataract surgery.
`In October of 2010, ISTA received FDA approval for once-
`daily BROMDAY, and the company discontinued shipments of XIBROM in Febmary 2011. ISTA acquied U.S_ ophthalmic
`rights to bromfenac in May 2002 under a license from Senju Phamiaceutiwls Co. Ltd. On June 6, 2012, Bausch + Lomb
`acquied ISTA Phannaceuticals, Inc.
`
`BROMDAY is currently the only once daiy treatment option it he $370 million U_S_ oph halmic nonsteroidal anti-
`inllammatory market. PROLENSA is an investigational drug and not yet available for commercial use.
`About Bausch + Lolnb
`Bausch + Lomb is one of the best-lmown and most respected healthcare companies in the world. Its core businesses include
`contact lenses and lens care products, ophthainic surgical devices and instruments, and ophthalmic pharmaceuticals.
`Founded in 1853, the company is headquartered in Rochester, N_Y_, and employs more than 11,000 people worldwide. Its
`products are avaiable in more than 100 countries. More inforrna ion is available at miMJzau.s.ch.mm,
`ll # #
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`News Media Contacts:
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`Teresa Panas
`Bausch + Lomb Phannaceuticals
`+1 973860-6382m
`Tad Heitrnann
`BioComm Network
`+1 714-273-2937 or theitmann@BioCommNelwork_com
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