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`... Newsroom 2013 Archive Bausch + Lomb Receives FDA Approval For PROLENSA™ (Bromfenac
`Home
`Ophthalmic Solution) 0.07%
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`FOR RELEASE 4/8/2013, Monday
`Bausch + Lomb Receives FDA Approval for PROLENSA™ (bromfenac
`ophthalmic solution) 0.07%
`New Once-Daily NSAID Indicated for Treatment of Postoperative Inflammation
`and Reduction of Ocular Pain Following Cataract Surgery
`MADISON, NJ - Bausch + Lomb, the global eye health company, today announced that the U.S. Food and Drug
`Administration (FDA) has approved the company's New Drug Application (NDA) for PROLENSA™ (bromfenac ophthalmic
`solution) 0.07 percent prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug (NSAID) for the
`treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
`PROLENSA will be available in 1.6ml and 3ml bottle sizes.
`PROLENSA provides powerful and rapid resolution of inflammation and pain by leveraging the unique potency of the
`bromfenac molecule in a formulation designed to facilitate ocular penetration. The advanced formulation allows for a lower
`concentration of bromfenac in a once daily dosing regimen. PROLENSA is a solution that does not require shaking to deliver
`a consistent dose in each drop.
`
`“The data show that once-daily dosing with PROLENSA provides powerful and rapid control of inflammation and pain
`following cataract surgery, confirming the potency of this NSAID and the benefits of the new formulation,” said Steven M.
`Silverstein, M.D., FACS, founder of Silverstein Eye Centers in Kansas City, MO. “PROLENSA reduces the amount of
`medication placed on the healing eye while maintaining a high degree of efficacy and ocular comfort."
`The efficacy of PROLENSA was evaluated in two randomized, double-masked, vehicle-controlled studies of patients
`undergoing cataract surgery. Each randomized patient received PROLENSA or vehicle starting with one drop into the
`surgical eye on the day prior to and the day of surgery, and for 14 days following surgery. The primary efficacy endpoint was
`complete clearing of ocular inflammation (assessed by the summed ocular inflammation score, SOIS, which includes cells
`and flare) by day 15. The secondary efficacy endpoint was the number of subjects that were pain free on day one after
`surgery.
`Results from the pivotal studies demonstrated PROLENSA to be superior to vehicle in the treatment of both inflammation and
`pain following cataract surgery. Twice as many patients as vehicle (46 percent versus 20 percent) demonstrated complete
`clearance of inflammation (SOIS of 0) at day 15. The difference in the average post-operative inflammation severity between
`the treatment and vehicle arms was statistically and clinically significant by day eight. Nearly four of five patients treated with
`PROLENSA were pain free at day one (78.8 percent versus 49.5 percent for vehicle; p<0.0001). Patients treated with
`PROLENSA reported a lower incidence of foreign body sensation and photophobia and had less redness than those treated
`with vehicle.
`“Bausch + Lomb is committed to delivering innovative therapeutic options to eye care professionals and the patients they
`serve, and the advanced formulation used for PROLENSA embodies that commitment,” said Dan Wechsler, executive vice
`president and president, Bausch + Lomb Global Pharmaceuticals. “We look forward to bringing this next evolution of the
`groundbreaking bromfenac franchise to our customers very soon.”
`PROLENSA Dosage and Administration
`Instill one drop into the affected eye once daily beginning one day prior to surgery, continued on the day of surgery, and
`through the first 14 days post surgery.
`Important Risk Information about PROLENSA
`Warnings and Precautions
`• Sulfite allergic reactions
`• Slow or delayed healing
`• Potential for cross-sensitivity
`• Increased bleeding of ocular tissues
`• Corneal effects, including keratitis
`• Contact lens wear
`Adverse Reactions
`• The most commonly reported adverse reactions in three – eight percent of patients were, anterior chamber inflammation,
`foreign body sensation, eye pain, photophobia, and blurred vision.
`Please see full prescribing information for PROLENSA.(53.5 KB, PDF)
`About Bausch + Lomb
`Bausch + Lomb is a leading global eye health company that is solely focused on protecting, enhancing, and restoring
`people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and
`ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive
`product portfolios in our industry, which are available in more than 100 countries. Founded in 1853, our company is
`headquartered in Rochester, NY, and employs more than 11,000 people worldwide.
`PROLENSA™ is a trademark of Bausch & Lomb Incorporated or its affiliates.
`# # #
`News Media Contacts:
`Teresa Gatto Panas
`Global Pharmaceutical Communications, Bausch + Lomb
`(973) 360-6382 or teresa.panas@bausch.com
`Tad Heitmann
`BioComm Network on behalf of Bausch + Lomb
`(714) 273-2937 or theitmann@BioCommNetwork.com
`US/PRA/13/0096
`
`Page 1 of 2
`
`SENJU EXHIBIT 2014
`LUPIN v. SENJU
`IPR2015-01105
`
`
`Professionals
`
`Text size A- A+
`Search...
`
`News - Related Links
`
`Media Contacts
`
`2014 Archive
`
`2013 Archive
`
`2012 Archive
`
`2011 Archive
`
`2010 Archive
`
`2009 Archive
`
`2008 Archive
`
`2007 Archive
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`United States
`
`Newsroom Careers
`Contact Us
`
`Investor Relations
`
`Our Products
`
`Vision and Age
`
`Your Eye Concerns
`
`Our Company
`
`... Newsroom 2013 Archive Bausch + Lomb Receives FDA Approval For PROLENSA™ (Bromfenac
`Home
`Ophthalmic Solution) 0.07%
`
`LikeLike
`
`0
`
`Tweet
`
`0
`
`FOR RELEASE 4/8/2013, Monday
`Bausch + Lomb Receives FDA Approval for PROLENSA™ (bromfenac
`ophthalmic solution) 0.07%
`New Once-Daily NSAID Indicated for Treatment of Postoperative Inflammation
`and Reduction of Ocular Pain Following Cataract Surgery
`MADISON, NJ - Bausch + Lomb, the global eye health company, today announced that the U.S. Food and Drug
`Administration (FDA) has approved the company's New Drug Application (NDA) for PROLENSA™ (bromfenac ophthalmic
`solution) 0.07 percent prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug (NSAID) for the
`treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
`PROLENSA will be available in 1.6ml and 3ml bottle sizes.
`PROLENSA provides powerful and rapid resolution of inflammation and pain by leveraging the unique potency of the
`bromfenac molecule in a formulation designed to facilitate ocular penetration. The advanced formulation allows for a lower
`concentration of bromfenac in a once daily dosing regimen. PROLENSA is a solution that does not require shaking to deliver
`a consistent dose in each drop.
`
`“The data show that once-daily dosing with PROLENSA provides powerful and rapid control of inflammation and pain
`following cataract surgery, confirming the potency of this NSAID and the benefits of the new formulation,” said Steven M.
`Silverstein, M.D., FACS, founder of Silverstein Eye Centers in Kansas City, MO. “PROLENSA reduces the amount of
`medication placed on the healing eye while maintaining a high degree of efficacy and ocular comfort."
`The efficacy of PROLENSA was evaluated in two randomized, double-masked, vehicle-controlled studies of patients
`undergoing cataract surgery. Each randomized patient received PROLENSA or vehicle starting with one drop into the
`surgical eye on the day prior to and the day of surgery, and for 14 days following surgery. The primary efficacy endpoint was
`complete clearing of ocular inflammation (assessed by the summed ocular inflammation score, SOIS, which includes cells
`and flare) by day 15. The secondary efficacy endpoint was the number of subjects that were pain free on day one after
`surgery.
`Results from the pivotal studies demonstrated PROLENSA to be superior to vehicle in the treatment of both inflammation and
`pain following cataract surgery. Twice as many patients as vehicle (46 percent versus 20 percent) demonstrated complete
`clearance of inflammation (SOIS of 0) at day 15. The difference in the average post-operative inflammation severity between
`the treatment and vehicle arms was statistically and clinically significant by day eight. Nearly four of five patients treated with
`PROLENSA were pain free at day one (78.8 percent versus 49.5 percent for vehicle; p<0.0001). Patients treated with
`PROLENSA reported a lower incidence of foreign body sensation and photophobia and had less redness than those treated
`with vehicle.
`“Bausch + Lomb is committed to delivering innovative therapeutic options to eye care professionals and the patients they
`serve, and the advanced formulation used for PROLENSA embodies that commitment,” said Dan Wechsler, executive vice
`president and president, Bausch + Lomb Global Pharmaceuticals. “We look forward to bringing this next evolution of the
`groundbreaking bromfenac franchise to our customers very soon.”
`PROLENSA Dosage and Administration
`Instill one drop into the affected eye once daily beginning one day prior to surgery, continued on the day of surgery, and
`through the first 14 days post surgery.
`Important Risk Information about PROLENSA
`Warnings and Precautions
`• Sulfite allergic reactions
`• Slow or delayed healing
`• Potential for cross-sensitivity
`• Increased bleeding of ocular tissues
`• Corneal effects, including keratitis
`• Contact lens wear
`Adverse Reactions
`• The most commonly reported adverse reactions in three – eight percent of patients were, anterior chamber inflammation,
`foreign body sensation, eye pain, photophobia, and blurred vision.
`Please see full prescribing information for PROLENSA.(53.5 KB, PDF)
`About Bausch + Lomb
`Bausch + Lomb is a leading global eye health company that is solely focused on protecting, enhancing, and restoring
`people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and
`ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive
`product portfolios in our industry, which are available in more than 100 countries. Founded in 1853, our company is
`headquartered in Rochester, NY, and employs more than 11,000 people worldwide.
`PROLENSA™ is a trademark of Bausch & Lomb Incorporated or its affiliates.
`# # #
`News Media Contacts:
`Teresa Gatto Panas
`Global Pharmaceutical Communications, Bausch + Lomb
`(973) 360-6382 or teresa.panas@bausch.com
`Tad Heitmann
`BioComm Network on behalf of Bausch + Lomb
`(714) 273-2937 or theitmann@BioCommNetwork.com
`US/PRA/13/0096
`
`Page 1 of 2
`
`SENJU EXHIBIT 2014
`LUPIN v. SENJU
`IPR2015-01105
`
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