Bmsch+IAmbRecdvesFDAAnxwdfixPROI£NSA'“0uombrxq)hflulmicmhfion)007%
`
`M B 5 United Statesv
`B A U S C H +
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`Home > ...> Newsroom ) 2013 Archive) Bausch + Lomb Receives FDA Approval For PROLENSA“‘ (Bromfenac
`Ophthalmic Solution) 0.07%
`
`E R55
`
`FOR RELEASE 4l8l2013, Monday
`Bausch + Lomb Receives FDA Approval for PROLENSA"- (bromfenac
`ophthalmic solution) 0.07%
`New Once-Daily NSAID Indicated for Treatment of Postoperafive Inflammation
`and Reduction of Ocular Pain Following Cataract Surgery
`
`MADISON, NJ — Bausch + Lomb, the global eye health company, today announced that he u.s. Food and Dnlg
`Administration (FDA) has approved the compam/s New Dmg Application (NDA) for PROLENSA" (bromfenac ophthalmic
`
`— R
`
`v
`-
`News
`elmed mks
`: “"“"““°'?"“‘
`l 2013 Archive
`n 2012 Archive
`n 2011 Archive
`
`I 20111Au=hi1e
`n zmggmmve
`
`n 2008 Archive
`solution) 0.07 percent prescription eye drop. an iinova ive oncedaily rionsteroidal anti—inflammatory dmg (NSAID) for he
`treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. m
`PROLENSA wil be available in 1.6ml and 3rnl bot le sizes.
`ll
`
`PROLENSA provides powerful and rapid resolution of inflammation and pain by leveraging the unique potency of the
`brornfenac molecule it 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—daiy dosing with PROLENSA provides powerful and rapid control of inflammation and pain
`following cataract surgery, conflming the potency of this NSAID and he benefits of the new formulation,‘ said Steven M.
`Silverstein, M.D., FACS, founder of Silverstein Eye Centers it Kansas City, MO. ‘PROLENSA reduces the amount of
`medication placed on the healing eye while maintaining a high degree of elficacy and ocular comfort.‘
`
`The etticacy of PROLENSA was evahated in two randomized, doublemasked, vehicle—controlled studies of patients
`undergoing cataract surgery. Each randomized pa ient received PROLENSA or vehicle starting with one drop into the
`surgical eye on the day priorto and the day of surgery, and for 14 days following surgery. The primary etlicacy 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 endpoiit was the number of subjects hat were pair 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 inflamma ion (SOIS of 0) at day 15. The difference in the average post—operative inflammation severity between
`the treatment and vehicle arms was statistically and cliiically significant by day eight. Nearty four of five patients treated wi h
`PROLENSA were pain free at day one (78.8 percent versus 49.5 percent for vehicle; p<l).0001). Patients treated with
`PROLENSA reported a lower incidence of foreign body sensa ion and photophobia and had less redness than those treated
`with vehicle.
`
`‘Bausch + Lomb is committed to delivering innovative therapeu ic options to eye care professionals and the patients they
`serve, and he advanced formulation used for PROLENSA embodies that cornmitrnent,' said Dan Wechsler, executive vice
`president and president, Bausch + Lomb Global Pharrnaceu icals. ‘We look forward to bringing this next evolu ion of the
`groundbreaking bromfenac franchise to our customers very soon.‘
`
`PROLENSA Dosage and Administration
`
`Instil one drop into the affected eye once daily begiining one day prior to surgery, continued on the day of surgery, and
`through the first 14 days post surgery.
`
`Important Risk lnfonnation about PROLENSA
`
`Warnings and Precautions
`- Sulfite allergic reactions
`- Slow or delayed healing
`- Potential for cross-sensi ivity
`- 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 pa ients were, anterior chamber inflammation,
`foreign body sensation, eye pain, photophobia, and blurred
`
`Please see full prescribim information for PROLENSA,
`
`(53.5 KB, PDF)
`
`httpzllwwwtrmsdr com/an-companylnewuumf20l341chivdfih4ppmv:L£ot—prolma[l2Il6f20l5 11113.15 AM]
`Page 1 of 2
`
`SENJU EXIHBIT 2218
`LUPHV V. SENJU
`IPR20l5-01100
`
`
`
`M B 5 United Statesv
`B A U S C H +
`See better. Live better.
`
`Newsroom | Careers
`
`|
`
`Investor Relations
`
`Contact Us
`
`Professionals
`For Eye Care
`
`
`Your Eye Concerns
`
`Our Products
`
`Vision and Age
`
`Home > ...> Newsroom ) 2013 Archive) Bausch + Lomb Receives FDA Approval For PROLENSA“‘ (Bromfenac
`Ophthalmic Solution) 0.07%
`
`E R55
`
`FOR RELEASE 4l8l2013, Monday
`Bausch + Lomb Receives FDA Approval for PROLENSA"- (bromfenac
`ophthalmic solution) 0.07%
`New Once-Daily NSAID Indicated for Treatment of Postoperafive Inflammation
`and Reduction of Ocular Pain Following Cataract Surgery
`
`MADISON, NJ — Bausch + Lomb, the global eye health company, today announced that he u.s. Food and Dnlg
`Administration (FDA) has approved the compam/s New Dmg Application (NDA) for PROLENSA" (bromfenac ophthalmic
`
`— R
`
`v
`-
`News
`elmed mks
`: “"“"““°'?"“‘
`l 2013 Archive
`n 2012 Archive
`n 2011 Archive
`
`I 20111Au=hi1e
`n zmggmmve
`
`n 2008 Archive
`solution) 0.07 percent prescription eye drop. an iinova ive oncedaily rionsteroidal anti—inflammatory dmg (NSAID) for he
`treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. m
`PROLENSA wil be available in 1.6ml and 3rnl bot le sizes.
`ll
`
`PROLENSA provides powerful and rapid resolution of inflammation and pain by leveraging the unique potency of the
`brornfenac molecule it 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—daiy dosing with PROLENSA provides powerful and rapid control of inflammation and pain
`following cataract surgery, conflming the potency of this NSAID and he benefits of the new formulation,‘ said Steven M.
`Silverstein, M.D., FACS, founder of Silverstein Eye Centers it Kansas City, MO. ‘PROLENSA reduces the amount of
`medication placed on the healing eye while maintaining a high degree of elficacy and ocular comfort.‘
`
`The etticacy of PROLENSA was evahated in two randomized, doublemasked, vehicle—controlled studies of patients
`undergoing cataract surgery. Each randomized pa ient received PROLENSA or vehicle starting with one drop into the
`surgical eye on the day priorto and the day of surgery, and for 14 days following surgery. The primary etlicacy 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 endpoiit was the number of subjects hat were pair 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 inflamma ion (SOIS of 0) at day 15. The difference in the average post—operative inflammation severity between
`the treatment and vehicle arms was statistically and cliiically significant by day eight. Nearty four of five patients treated wi h
`PROLENSA were pain free at day one (78.8 percent versus 49.5 percent for vehicle; p<l).0001). Patients treated with
`PROLENSA reported a lower incidence of foreign body sensa ion and photophobia and had less redness than those treated
`with vehicle.
`
`‘Bausch + Lomb is committed to delivering innovative therapeu ic options to eye care professionals and the patients they
`serve, and he advanced formulation used for PROLENSA embodies that cornmitrnent,' said Dan Wechsler, executive vice
`president and president, Bausch + Lomb Global Pharrnaceu icals. ‘We look forward to bringing this next evolu ion of the
`groundbreaking bromfenac franchise to our customers very soon.‘
`
`PROLENSA Dosage and Administration
`
`Instil one drop into the affected eye once daily begiining one day prior to surgery, continued on the day of surgery, and
`through the first 14 days post surgery.
`
`Important Risk lnfonnation about PROLENSA
`
`Warnings and Precautions
`- Sulfite allergic reactions
`- Slow or delayed healing
`- Potential for cross-sensi ivity
`- 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 pa ients were, anterior chamber inflammation,
`foreign body sensation, eye pain, photophobia, and blurred
`
`Please see full prescribim information for PROLENSA,
`
`(53.5 KB, PDF)
`
`httpzllwwwtrmsdr com/an-companylnewuumf20l341chivdfih4ppmv:L£ot—prolma[l2Il6f20l5 11113.15 AM]
`Page 1 of 2
`
`SENJU EXIHBIT 2218
`LUPHV V. SENJU
`IPR20l5-01100
`
`
`
`Bmsch+InmbRecdvcsFDAAp|xwdforPR0I£NSA'I0uomhrmophflnhi:sohfim)007%
`
`About Bausclr + Lomb
`
`Bausch+ Lombisa leadinggobaleyehealth companythatissolelyfocusedon protecting,enhancing,andrestoring
`people's eyesight Our core businesses include ophthalmic pharmaceuticds, contact lenses and lens care prorircts, aid
`ophthdmic surgical devices and 'nstnlnents_ We globaly develop, manufacture and market one of the most comprehensive
`product portfolios in our industry, which are avaiable in more than 100 countries. Founded in 1853, our company is
`headquztered in Rochester, NY, and employs rnorethar 11,000 peopleworldwide.
`
`PROLENSA" is a trademark ofBausch & Lomb Incorporated orits afliliates
`# # #
`
`News Media Contacts:
`
`Teresa Gatto Panas
`Global Phamaceu ical Cornmurica ions, Bausch + Lornb
`(973) 360-6382 or l.eLesa.panas@hausd1.mrn
`Tad Heitmann
`Biocomm Network on behalf of Bausch + Lornb
`(714) 2734937 or mmmm
`USlPRAl13I0096
`
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`Allirforrriatiorrarrdmataridsorr hissitepertai'rhtheU.S.orrly,mlessoherwiseirdcated.
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`Page 2 of 2
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