Bausch + Lomb Submits New Drug Application for Once-Daily PROLENSA™ to Treat Ocular Inflammation and Pain Following Cataract Surgery
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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
`
`Tweet
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` FOR RELEASE 6/18/2012, Monday
`Bausch + Lomb Submits New Drug Application for Once-Daily PROLENSA™
` to Treat Ocular Inflammation and Pain Following Cataract Surgery
`MADISON, N.J. — Bausch + Lomb, the global eye health 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™ (bromfenac
` ophthalmic solution), a once-daily topical nonsteroidal anti-inflammatory compound for the treatment 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 BROMDAY™ (bromfenac ophthalmic solution) 0.09
` percent, in a new formulation.
`
`“The new, optimized formulation used for PROLENSA allows for a lower concentration of bromfenac, while maintaining the
` convenience of once-daily use currently 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 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 medical advances to medical
` professionals and their patients,” said Marvin Garrett, vice president of U.S. Regulatory Affairs, Quality Assurance and
` Compliance, Bausch + Lomb. “It’s also a timely example of the progress we continue to make on critical D&R programs as
` we work 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 (bromfenac ophthalmic solution) 0.09
` percent in a new formulation. From 2005 until 2011, ISTA Pharmaceuticals, Inc. marketed XIBROM (bromfenac ophthalmic
` solution)® 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-
`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.
`
`BROMDAY is currently the only once daily treatment option in the $370 million U.S. ophthalmic nonsteroidal anti-
`inflammatory market. 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 include
` 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. Its
` products are available in more than 100 countries. More information is available at www.bausch.com.
`
`# # #
`News Media Contacts:
`Teresa Panas
` Bausch + Lomb Pharmaceuticals
` +1 973-360-6382 or teresa.panas@bausch.com
`
`Tad Heitmann
` BioComm Network
` +1 714-273-2937 or theitmann@BioCommNetwork.com
`
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`http://www.bausch.com/our-company/newsroom/2012-archive/new-drug-application-for-once-daily-prolensa[12/16/2015 11:27:39 AM]
`
`Page 1 of 2
`
`SENJU EXHIBIT 2229
`LUPIN v. SENJU
`IPR2015-01099
`
`
`
`United States
`
`Newsroom
`
`Careers
`
`Investor Relations
`
`Contact Us
`
`For Eye Care
` Professionals
`
`Text size A- A+
`
`Our Products
`
`Vision and Age
`
`Your Eye Concerns
`
`Our Company
`
`
`
` News - Related Links
`
`Media Contacts
`2014 Archive
`2013 Archive
`2012 Archive
`2011 Archive
`2010 Archive
`2009 Archive
`2008 Archive
`2007 Archive
`
`Home ... Newsroom 2012 archive Bausch + Lomb Submits New Drug Application For Once-Daily PROLENSA™ To
` Treat Ocular Inflammation And Pain Following Cataract Surgery
`
`Tweet
`
`
` FOR RELEASE 6/18/2012, Monday
`Bausch + Lomb Submits New Drug Application for Once-Daily PROLENSA™
` to Treat Ocular Inflammation and Pain Following Cataract Surgery
`MADISON, N.J. — Bausch + Lomb, the global eye health 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™ (bromfenac
` ophthalmic solution), a once-daily topical nonsteroidal anti-inflammatory compound for the treatment 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 BROMDAY™ (bromfenac ophthalmic solution) 0.09
` percent, in a new formulation.
`
`“The new, optimized formulation used for PROLENSA allows for a lower concentration of bromfenac, while maintaining the
` convenience of once-daily use currently 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 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 medical advances to medical
` professionals and their patients,” said Marvin Garrett, vice president of U.S. Regulatory Affairs, Quality Assurance and
` Compliance, Bausch + Lomb. “It’s also a timely example of the progress we continue to make on critical D&R programs as
` we work 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 (bromfenac ophthalmic solution) 0.09
` percent in a new formulation. From 2005 until 2011, ISTA Pharmaceuticals, Inc. marketed XIBROM (bromfenac ophthalmic
` solution)® 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-
`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.
`
`BROMDAY is currently the only once daily treatment option in the $370 million U.S. ophthalmic nonsteroidal anti-
`inflammatory market. 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 include
` 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. Its
` products are available in more than 100 countries. More information is available at www.bausch.com.
`
`# # #
`News Media Contacts:
`Teresa Panas
` Bausch + Lomb Pharmaceuticals
` +1 973-360-6382 or teresa.panas@bausch.com
`
`Tad Heitmann
` BioComm Network
` +1 714-273-2937 or theitmann@BioCommNetwork.com
`
`Vision and Eye Health
`Vision and Age
`Eye Infections & Irritations
`Diseases and Disorders
`Find a Doctor
`Eye Exam Check List
`
`Products
`Contact Lenses
`Contact Lens Care
`Dry Eye Products
`Allergy/Redness Relief
`Rx Pharmaceutical
`
`Customer Support
`Contact Us
`Customer policies and forms
`Rebate Center
`Worldwide Locations
`
`Legal
`Legal Notice
`Privacy Policy
`Material Safety Data Sheets
`
`Newsroom
`Careers
`Investor Relations
`Grants & Contributions
`
`http://www.bausch.com/our-company/newsroom/2012-archive/new-drug-application-for-once-daily-prolensa[12/16/2015 11:27:39 AM]
`
`Page 1 of 2
`
`SENJU EXHIBIT 2229
`LUPIN v. SENJU
`IPR2015-01099
`
`
`
`Bausch + Lomb Submits New Drug Application for Once-Daily PROLENSA™ to Treat Ocular Inflammation and Pain Following Cataract Surgery
`
`Eye Vitamins
`Surgical Products
`Vision Accessories
`
`© 2015 Bausch & Lomb Incorporated.
`
`All information and materials on this site pertain to the U.S. only, unless otherwise indicated.
`
`
`
`http://www.bausch.com/our-company/newsroom/2012-archive/new-drug-application-for-once-daily-prolensa[12/16/2015 11:27:39 AM]
`
`Page 2 of 2
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