Bausch + Lomb Submits New Drug Application for Once-Daily PROLENSA"' to Treat Ocular Inflammation and Pain Following Cataract Surgery
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`Horne > ... > 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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`FOR RELEASE 6/18/2012, Monday
`Bausch + Lomb Submits New Drug Application for Once-Daily PROLENSA r M
`to Treat Ocular Inflammation and Pain Following Cataract Surgery
`MADISON, N J. - Bausch + Lomb, the global eye heatth company, announced today that it has submitted a New Drug
`Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for PROLENSA"' (bromf enac
`ophthalmic solution), a once-daily topical nonsteroidal anti-inflammat01y compound for the trealment of ocular inflammation
`and pain following cataract surgery. PROLENSA, developed by recently acquired ISTA Pharmaceuticals, Inc., incorporates a
`lower concentration of bromfenac than the currently available once-daily BROMDA Y"' (bromfenac ophthalmic solution) 0.09
`percent, in a new formulation.
`
`"The new, optimized formulation used for PROLENSA allows for a lower concentration of bromf enac, while maintaining the
`convenience of once-daily use currenUy prescribed with BROMDAY," stated Calvin Rober1s, 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 licensor, Senju Pharmaceutical Co. Ltd., by the United States Patent and Trademark Office.
`
`"The PROLENSA filing is an important step towards bringing safe, effective and meaningful rnedicat advances to medical
`professionals and their patients," said Marvin Garrett, vice president of U.S. Regulatory Affairs, Quality Assurance and
`Compliance, Bausch + Lomb. "lfs also a timely example of the progress we continue to make on critical D&R programs as
`we worll to bring together the best of ISTA Pharmaceuticals and Bausch + Lomb."
`
`About PROLENSA"'
`PROLENSA (bromfenac ophthalmic solution) is being developed as a once-daily topical nonsteroidal anti-inflammatory
`compound for the treatment of ocular inflammation and pain following cataract surgery. PROLENSA incorporates a lower
`concentration of bromfenac than the company's current once-daily NSAID, BROMDAY (bromf enac ophthalmic solution) 0 09
`percent in a new formulation. From 2005 untii 2011,1STA Pharmaceuticals, Inc. marketed XIBROM (bromfenac ophthalmic
`solution)l!> 0 09 percent in the U.S. for twice-daily use for the treatment of postoperative inflammation and the reduction of
`ocular pain in patients who have undergone cataract surgery. In October of 2010, ISTA received FDA approval for once(cid:173)
`daily BROMDAY, and the company discontinued shipments of XIBROM in February 2011 . ISTA acquired U.S. ophthalmic
`rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. ltd. On June 6, 2012, Bausch+ Lomb
`acquired ISTA Pharmaceuticals, Inc.
`
`BROMDA Y is currenUy the only once daily treatment option in the $370 million U.S. ophthalmic nonsteroidal anti(cid:173)
`inflammatory marllet. PROLENSA is an investigational drug and not yet available for commercial use.
`
`About Bausch + Lomb
`Bausch + lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses indude
`contact lenses and lens care products, ophthalmic 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. tts
`products are available in more than 100 countries. More information is available at www.bausch corn.
`
`# # #
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`Teresa Panas
`Bausch + Lomb Pharmaceuticals
`+1 973-36~82 or teresa panas@l>auscb com
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`Tad Heitmann
`BioComm Networll
`+1 714-273-2937 or lheitmann@BioCommNe!work com
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`hUp://www bausch comlout-company/newsroom/2012-archive/new-drug"'J'Plication-for-<>nee-daily-prolensa[l2116/20 15 I I :27:39 AM]
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`SENJU EXHIBIT 2229
`INNOPHARMA v SENJU
`IPR2015-00903
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`Bausch+ Lomb Submits New Drug Application for Once-Daily PROLENSA'" to Treat Ocular Inflammation and Pain Following Cataract Surgery
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