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`Home > ... > Newsroom > 2013 Archive > Bau sch + Lomb Receives FDA Approval For PROLENSA.,... (Bromfenac
`Ophthalmic Solution) 0 07%
`
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`FOR RELEASE 4/8/2013. Monday
`Bausch + Lomb Receives FDA Approval for PROLENSA TM (bromfenac
`ophthalmic solution) 0.07%
`
`New Once--Daily NSA/0 Indicated for Treatment of Postoperative Inflammation
`
`and Reduction of Ocular Pain Following Cataract Surgery
`
`MADISON, NJ- Bausch+ Lomb, the global eye heatth company. today announced that the U.S. Food and Drug
`Administration (FDA) has approved the company's New Drug Application ( NOA) for PROLENSA Till (bromfenac ophthalmic
`solution) 0 07 percent prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug (NSAID) lor the
`treatment of postoperative inflammation and reduction of ocular pail il 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 pail by leveraging the unique potency of the
`bromfenac molecule in a formulation designed to facilitate ocular penetration. The advanced formulation al ows for a lower
`concentration of bromfenac in a once dal y dosing regimen. PROLENSA is a solution that does not require shaking to deliver
`a consistent dose in each drop.
`
`•The data show that once-daity dosilg with PROLENSA provides powerful and rapid control of inflammation and pain
`following cataract surgery. confirming the potency of this NSA 0 and the benefrts of the new formulation, • said Steven M.
`Silversteil. M 0 ., FACS, founder of Sitverstein Eye Centers il Kansas City, MO. •PROLENSA reduces the amount of
`medication placed on the healilg eye while mailtaining a high degree of efficacy and ocular comfort. •
`
`The efficacy of PROLENSA was evaluated il 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 lor 14 days following surgery. The primary efficacy endpoint was
`complete clearing of ocular inflammation (assessed by the summed ocular inflammation score, 5015 , which includes cells
`and flare) by day 15. The secondary efficacy endpoilt 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
`pail following cataract surgery. Twice as many patients as vehicle (46 percent versus 20 percent) demonstrated complete
`clearance of inflammation (SOlS of 0) at day 15. The difference in the average post~rative inflammation severity between
`the treab'nent and vehicle arms was statistically and cinical y 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.
`
`•sausch + 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 brilging this next evolution of the
`groundbreaking bromfenac franchise to our customers very soon:
`
`PROlENSA Dosage and Administration
`
`Instil 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 R isk Information about PROLENSA
`
`Warnings and Precautions
`• Sutfite 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 prescribjog jnfocmatjoo for pRO! FNSA (i!lil (53.5 KB, PDF)
`
`SENJU EXHIBIT 2218
`INNOPHARMA v SENJU
`IPR2015-00903
`
`PAGE 1 OF 2
`
`
`See better. Live better.
`
`For Eye Care
`Profess•onals
`- - - - -
`Text size A- A+
`
`Home > ... > Newsroom > 2013 Archive > Bau sch + Lomb Receives FDA Approval For PROLENSA.,... (Bromfenac
`Ophthalmic Solution) 0 07%
`
`OUr Company
`
`News - Related Lmks
`
`D Med ja Contacts
`D 2DHAn:b~
`D 2DlJAn:b~
`D 2Dl2An:b~
`D 2Dl l An:b~
`D 2DlDAn:b~
`D 2Dil2An:b~
`D 2DD8An:b~
`D 2DDZAn:b~
`
`FOR RELEASE 4/8/2013. Monday
`Bausch + Lomb Receives FDA Approval for PROLENSA TM (bromfenac
`ophthalmic solution) 0.07%
`
`New Once--Daily NSA/0 Indicated for Treatment of Postoperative Inflammation
`
`and Reduction of Ocular Pain Following Cataract Surgery
`
`MADISON, NJ- Bausch+ Lomb, the global eye heatth company. today announced that the U.S. Food and Drug
`Administration (FDA) has approved the company's New Drug Application ( NOA) for PROLENSA Till (bromfenac ophthalmic
`solution) 0 07 percent prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug (NSAID) lor the
`treatment of postoperative inflammation and reduction of ocular pail il 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 pail by leveraging the unique potency of the
`bromfenac molecule in a formulation designed to facilitate ocular penetration. The advanced formulation al ows for a lower
`concentration of bromfenac in a once dal y dosing regimen. PROLENSA is a solution that does not require shaking to deliver
`a consistent dose in each drop.
`
`•The data show that once-daity dosilg with PROLENSA provides powerful and rapid control of inflammation and pain
`following cataract surgery. confirming the potency of this NSA 0 and the benefrts of the new formulation, • said Steven M.
`Silversteil. M 0 ., FACS, founder of Sitverstein Eye Centers il Kansas City, MO. •PROLENSA reduces the amount of
`medication placed on the healilg eye while mailtaining a high degree of efficacy and ocular comfort. •
`
`The efficacy of PROLENSA was evaluated il 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 lor 14 days following surgery. The primary efficacy endpoint was
`complete clearing of ocular inflammation (assessed by the summed ocular inflammation score, 5015 , which includes cells
`and flare) by day 15. The secondary efficacy endpoilt 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
`pail following cataract surgery. Twice as many patients as vehicle (46 percent versus 20 percent) demonstrated complete
`clearance of inflammation (SOlS of 0) at day 15. The difference in the average post~rative inflammation severity between
`the treab'nent and vehicle arms was statistically and cinical y 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.
`
`•sausch + 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 brilging this next evolution of the
`groundbreaking bromfenac franchise to our customers very soon:
`
`PROlENSA Dosage and Administration
`
`Instil 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 R isk Information about PROLENSA
`
`Warnings and Precautions
`• Sutfite 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 prescribjog jnfocmatjoo for pRO! FNSA (i!lil (53.5 KB, PDF)
`
`SENJU EXHIBIT 2218
`INNOPHARMA v SENJU
`IPR2015-00903
`
`PAGE 1 OF 2
`
`
`
`Bausch +Lomb Receives FDA Approval for PROLENSA lll (bromfenac ophthalmic solution) 0 07%
`
`About Bausch + Lomb
`
`Bausch + Lomb is a leading global eye heaHh company that is solely focused on protecting, enhancing, and restoring
`people's eyesight. Our core businesses indude ophthalmic phannaceuticals, 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 tradematk of Bausch & Lomb Incorporated or its affiliates.
`
`# # #
`
`News Media Contacts
`
`Teresa Gatto Panas
`Global Phannaceutical Communications, Bausch + Lomb
`(973) 360-6382 or teresa panas@bausch com
`
`Tad Heitmann
`BioComm Network on behalf of Bausch + Lomb
`(714) 273-2937 or thettmann@BioCommNetwor!s com
`
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`PAGE 1 OF 2
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