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`Home > ... > Newsroom > 2013 Archive ) Bausch + Lomb Launches PROLENSA"" And Showcases In nova ive Additions
`To Its Surgical Product Portfolio At The ASCRS Annual Meeting
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`FOR RELEASE 4/17/2013, Wednesday
`Bausch + Lomb Launches PROLENSA TM and Showcases Innovative
`Additions to its Surgical Product Portfolio at the ASCRS Annual Meeting
`U .S. Debut for New Once-Daily PROLENSA"' (bromfenac ophthalmic solution) 0.07 percent
`Special Cataract and Refractive Surgical Suites on Display, with Featured
`Demonstrations ofthe VICTUS"' Femtosecond Laser Platform
`ROCHESTER. NY-Bausch+ Lomb. the global eye health company. will debut PROLENSA,.. (bromfenac ophthalmic
`solu ion} 0.07 percent, its newly approved nonsteroidal an i-inflammatory ophthalmic solution, and highlight innovative
`additions to its comprehensive line of ophthalmic surgical instruments and therapeutics at its booth (#1926} during the
`upcoming Annual American Society of Cataract and Refrac ive Surgery (ASCRS} Symposium (San Francisco, Calif., April
`19-23}. Attendees w ill also be able to participate in surgical equipment demonstrations. attend scientific symposia, aCME
`event and booth talks, and see two dozen sdentific podium presenla ions and posters related to Bausch+ Lomb's
`oph halmic pharmaceutical and surgical offerings.
`New Products and Solutions- The More You Look, The More You See
`Among its wide range of pharmaceutical and surgical solu ions, Bausch +Lomb will debut the recenUy approved
`PROLENSA (bromfenac oph halmic solution} 0.07 percent prescription eye drop, a new once-<laily nonsteroidal anti(cid:173)
`inflammatory drug (NSAID} tor the treatment of postoperative inflamma ion and reduc ion of ocular pain in pa ients who
`have undergone cataract surgery. PROLENSA is an advanced fOrmulation of Bromday® (bromfenac ophthalmic solution}
`0.09 percent that provides powerful and rapid resolution of inflammation and pain from cataract surgery by leveraging the
`unique potency of the bromfenac molecule and effective ocular penetra ion. The ad\'anced fOrmulation allows for a lower
`concentration ofthe active ingredient bromfenac. while maintaining the convenience of once daily dosing. PROLENSA will
`be available in 1.6ml and 3ml botue sizes.
`
`The company also will highlight LOTEMAX® (loteprednol eta bonate ophthalmic gel} 0.5 percent gel drop fOrmulation, a
`new topical cor icosteroid formula ion in its line of loteprednol eta bonate C-20 ester corticosteroid-based ophthalmic
`products. Introduced in January, LOTEMAXGel is indicated for he treatment of post-operative inflammation and pain
`fOllowing ocular surgery. The unique LOTEMAX Gel drop formulation is engineered to adhere to the ocular surface through
`its mucoadhesive technology. LOTEMAX Gel also provides dose uniformity, ensuring that a consistent con centra ion of
`loteprednol is delivered in every drop, with no shaking to resuspend he drug required.
`Bausch+ Lomb will oner demonstra ions of its cutllng edge surgical platform, the VICTUS"' femtosecond laser platform, by
`appointment which can be scheduled atthe Bausch +Lomb booth (#1926}. And, w i h the recent announcement of a global
`distribution agreement with Leica Microsystems, the Bausch +Lomb boo h will feature several Leica Microsystems
`oph halmic microscopes.
`The company will also showcase he latest addi ions to its Bausch + Lomb Storz® industry-leading ophthalmic instrument
`portfolio for refractive, cataract and vitreo-retinal surgery. This will include a specialized set of instruments designed
`specifically to complement femtosecond laser procedures and a set of instrumentation for the new Descemers Membrane
`Endothelial Keratoplasty procedure developed by Thomas John, M.D., in Chicaqo, Ill. The instruments will be available for
`purchase at he Bausch+ Lomb booth (#1926}.
`Scientific Symposia
`Bausch+ Lomb is sponsoring three sdentific symposia including he following:
`·"A New Advancementin the Ocular Delivery ofLoteprednol Etabonate: on saturday, April20 from 7 - 9 p.m. PDT at the
`InterContinental Hotel's Grand Ballroom.
`• "HoiTopics in Cataract Surgery: Femtosecond & IOL Controversies," on Sunday, April21 from 5 -6:30 p.m. PDT at he
`InterContinental Hotel's Grand Ballroom.
`· ·selecting an NSAID fOr Surgery: What Really Matters?," on Sunday, April 19 frOm 7:30 - 9:30 p.m. PDT at the
`InterContinental Hotel's Grand Ballroom.
`Booth Talks
`Bausch+ Lomb will host a series ofinterac ive programs in its booth covering the ruure of cataract surgery, product
`innovation and practice management. These talks will be led by an impressive and diverse group of highly regarded
`speakers. including Drs. Rob Weinstock, John Sheppard, Marl< Packer and JeffWhiman. The talkS begin on Saturday,
`April20 and con inue through Monday, April 22. A full schedule will be available at llle Bausch +Lomb booth (#1926}.
`In addition, the company's chief medical officer, Cal Roberts, M.D., and o her members of the Global Medical Affairs team
`will be on hand to engage the ophthalmic community and answer questions.
`CME Ev ents
`Bausch+ Lomb is suppor ing, "KnoCking Down Inflammatory Barriers to Success in Refractive Cataract Surgery: aCME
`evenlfeaturing moderator Terry Kim, M.D.; and faculty, David F. Chang, M.D.; Uday Devgan, M.D.; Francis S. Mah, M.D.;
`and Keith Warren, M.D. The event is scheduled to lake place on Saturday, April20 from 5:30 - 6:30p.m., with registration
`opening at 5 p.m.
`Scientific Podium Presentations and Posters
`Bausch+ Lomb will present 23 podium presentations and e-posters, including several on he new en Vista® hydrophobic
`acrylic intraocular lens, the first and only IOL approved in the U.S. wi h labeling that slates: "No glistenings of any grade
`were reported fOr any subject at any visit in the clinical study".1·2
`The schedule fOr all Bausch + Lomb podium presentations and posters is as follows:
`Saturday:
`End I MJ, et at. "Assessment of Corneal Rap ThiCkness Precision wi h New Femtosecond Laser.· (ASCRS Posters P2:
`Keratorefrac ive: KIOSKS (Moscone} Saturday, April20, 8 a.m.- 5 p.m. PDT]
`
`PAGE 1 OF 4
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`SENJU EXHIBIT 2211
`INNOPHARMA v SENJU
`IPR2015-00903
`
`

`
`Majmudar P. et aL ·safety of Besiffoxacin Ophtllalmic Suspension 0.6 percent in Cataract Surgery Patients: Prospective
`Surveillance study: [ASCRS Posters P1: Intraocular Surgery (Cataract and Refractive): KIOSKS (Moscone) saturday, April
`20 8 a.m.- 5 p.m. PDT)
`Raj pal R, et aL "Resolu ion of Anterior Chamber Cells and Flare w itn Loteprednol Etabonate 0.5 percent Gel: New
`Treatment for Post-Cataract Inflammation and Pain." [ASCRS Posters P1: Intraocular Surgery (Cataract and Refrac ive):
`KIOSKS (Moscone) saturday, April 20 8 a.m.- 5 p.m. PDT]
`Stephenson P, et aL "Clarity of Vision w i h New Hydrophobic Acrylic IOL" [ASCRS Posters P1: Intraocular Surgery: KIOSKS
`(Moscone) Saturday, April20, 8 a.m. - 5 p.m. PDT)
`Stodulka P, et aL "High-Volume Use of Femtosecond Laser-Assisted Cataract Surgery." [ASCRS Posters P1: Intraocular
`Surqery: KIOSKS (Moscone) Saturday, April20, 8 a.m. - 5 p.m. PDn
`Ang RT et aL "Prospective Comparison of 1 Accommodating and 2 Multifocal IOLs: Visual Acuity, Refractive outcome and
`Contrast Sensitivity at Year 1: [ASCRS Paper Session 1-C: Intraocular Surgery Presbyopia-Correcting IOLs: Room 121
`(Moscone). Saturday, April 20, 1 - 2:30pm. PDT)
`Chu R, Pepose JS, Qazi MA et aL "Comparison of NEt-RQL-42 and SVt Quality of Life Measures After Bilateral lmplanta ion
`of 3 FDA-Approved Presbyopia-Correcting IOLs at 6-mon hs." [ASCRS Paper Session 1-C: Intraocular Surgery Presbyopia(cid:173)
`correcting IOLs: Room 121 (Moscone). saturday, April20, 1 - 2:30 p.m. PDT)
`Dell SJ et aL "Comparison of Free-Aoating Capsulotomy- Rate of 2 Femtosecond Laser Systems for Cataract Surgery."
`[ASCRS Paper Session 1-B: Intraocular Surgery Femtosecond Laser: Room 130 (Moscone). Saturday, April20, 1 -2:30
`p.m. PDT)
`Stephenson P et aL · use of Intraoperative wavefront Aberrometer wi h New Aspheric Hydropnobic Acrylic IOL." [ASCRS
`Paper Session 1-D: Intraocular Surgery Power Calculations: Room 123 (Moscone). Saturday, April20, 1 - 2:30pm. PDT)
`Chee s. T1 SetaL "Early Visual outcomes of First 100 Cases of Femtosecond Laser-Assisted Cataract Surgery at
`Oph halmic Institution in Singapore: [ASCRS Paper Session 1- G: Intraocular Surgery Femtosecond laser: Room 120
`(Moscone). Saturday, April20, 3 - 4:45p.m. PDT)
`Daya SM. Nanavaty MA. Espinosa MetaL "Ultrasound Power. Translenticular Hydrodissection and Lens Fragmenta ion in
`Femtosecond laser cataract surgery: [ASCRS Paper session 1-G: Intraocular surgery Femtosecond laser: Room 120
`(Moscone). Saturday, April 20, 3 - 4:45 p m. PDT)
`Pepose JS, Qazi MA et aL "Prospec ive Randomized Evaluation of Bilaterallmplanta ion of 3 FDA-Approved Presbyopia(cid:173)
`Correcting IOLs at 6-montns." [ASCRS Paper Session 1-1: Intraocular Surgery Presbyopia-Correcting IOLs: Room 130
`(Moscone). Saturday, April 20. 3-4:30 p.m. PDT)
`Qazi MA, Chu R, Pepose JS et aL "Evalua ion of Visual Metrics Using OQAS Alter Bilateral Implantation of Accommodating
`or MultifocaiiOLs." [ASCRS Paper Session 1-1: Intraocular Surgery Presbyopia-Correcting IOLs: Room 130 (Moscone).
`Saturday, April 20, 3-4:30 p.m. PDT)
`Sunday:
`Kandavel R. Colvard MetaL "Seven-Year Visual Acuity outcomes witn an Accommodating IOL." [ASCRS Paper session 2-
`c: Intraocular Surgery Presbyopia-Correcting IOLs: Room 123 (Moscone). Sunday, April 21, 8- 9:30 a.m. PDT)
`Page TP et aL "Management of Post-ocdusion Surge wi h Advanced Fluidics: [ASCRS Paper Session 2-E: Intraocular
`Surgery Phaco Technology: Room 125 (Moscone). Sunday, April21, 8- 9:30 a.m. PDT)
`Schechter Bet aL "Improved Surgical Efficiency w itn Newer Model Phacoemulsificaton System." [ASCRS Paper Session 2-
`E: Intraocular surgery Phaco Technology: Room 125 (Moscone). sunday, April21, 8- 9:30a.m. PDT)
`Roberts, c. Stodulka. P. "Improved Surgical Productivity Witn Incorporation of Femtosecond Laser in Cataract Surgery.·
`[ASCRS Paper Session 2-A: Intraocular Surgery Femtosecond Laser: Room 120 (Moscone) 8 - 9:30 a.m. PDT)
`Whitman Jet aL "Anterior Capsulotomy Diameter Accuracy and Refrac ive OUtcomes using Femtosecond Laser: [ASCRS
`Paper Session 2-A: Intraocular Surgery Femtosecond Laser: Room 120 (Moscone). Sunday, April21, 8- 9:30 am. PDT]
`Haq F. Whitman Jet aL ·corneal A ap Creation witn New Femtosecond Laser used During LASIK." [ASCRS Paper Session
`2-J: Intraocular Surgery Keratorefractive LASIK: Room 123 (Moscone). Sunday, April 21, 1 - 2:30 p.m. PDT)
`Wallace Ret al. "Burst Hemittip Approach to Phacoemulsification: Eflect of Stable Chamber Fluidics on Nuclear
`Disassembly and Removal." [ASCRS Paper Session 2-0: Intraocular Surgery Phaco: Room 121 (Moscone). Sunday, April
`21.3- 4:30 p.m. PDT]
`Monday:
`Guedj M, Monnet Del aL "Prospective Evaluation of New Hydrophobic Toric IOL" [ASCRS Paper Session 4-C: Intraocular
`Surgery Toric IOLs: Room 125 (Moscone). Monday, April22, 8-9:30 a.m. PDT)
`Malyugin BE, Golovin AV etaL "Clinical Outcomes witn New Hydrophobic Acrylic IOL." [ASCRS Paper Session 4-F:
`Russian Papers: Room 125 (Moscone). Monday, April22. 8-9:45 a.m. PDT)
`Nichellllill LD t:l al. " Rota io1111l Sla!Jilily of Nt:w Fullla!Jit: Ollt:-Pit:Ct: Hyllruptou!Jic Acoy lic IOL" [ASGRS Papt:r St:ssiull 4-B.
`Intraocular Surgery Monofocal IOLs: Room 121 (Moscone). Monday. April 22, 8 - 9:30 a.m. PDT)
`Packer MetaL "Implantation of Glistening-Free One-Piece Hydrophobic Acrylic IOL in Cataract patients: Safety and Visual
`OUtcomes." [ASCRS Paper Session 4-H: Intraocular Surgery MonofocaiiOLs: Room 123 (Moscone). Monday, April 22, 10
`- 11:30 a.m. PDT)
`About PROLENSA
`PROLENSA"' (bromfenac ophthalmic solution) 0.07 percent is a once-daily, topical nonsteroidal an i-inflammatory drug
`(NSAID) indicated fortne treatment of postopera ive inflammation and reduction of ocular pain in patients who have
`undergone cataract surgery. PROLENSA is an advanced formulation of BROMO A '1'1® (bromfenac ophtnalmic solu ion) 0.09
`percent tnat provides proven once-daily emcacy witn a lower concentration of bromfenac.
`Dosage and Administration
`Ins ill one drop into the affected eye once daily beginning one day prior to surgery, continued on tne day of surgery, and
`tnrough he first 14 days post surgery.
`lmpor1ant Risk Information about PROLENSA (bromfenac ophtnalmic solution) 0.07 percent
`Warnings and Precautions
`Sulfite allergic reac ions
`
`Slow or delayed healing
`
`Potential for cross-sensitivity
`
`Increased bleeding of ocular tissues
`
`Corneal effects. including kera itis
`
`Contact lens wear
`
`Adverse Reactions
`The most commonly repor1ed adverse reactions in tnree- eight percent of patients were. anterior chamber inflammation.
`foreign body sensa ion, eye pain, photophobia, and blurred vision.
`
`Please see lull prescribing information(53 5 KB, PDF) for PROLENSA
`About LOTEMAX GEL
`LOTEMAX® GEL is a corticosteroid indicated for tne treatment of postoperative inflammation and pain following ocular
`surgery. Loteprednol eta bonate, he active ingredient in LOTEMAX GEL. was first approved as an ocular anti-inflammatory
`
`PAGE 2 OF 4
`
`

`
`agent by he FDA in 1998 as LOTEMAX (lotepre<lenol etabonate ophthalmic suspension) 0 .5 percent in<licate<l for the
`treatment of steroi<l-responsive innammatory con<lifions oflhe palpebral an<l bulbar conjunctiva. come a. an<l anterior
`segment of the globe. such as allergic conjuncfivitis, acne rosacea. superficial punc1ate kera itis, herpes zoster kera itis,
`iritis, cyclifis, selecte<l infective conjunctivifi<les. when the inherent hazar<l ofsteroi<l use is accepte<l to obtain an a<lvisable
`<liminufion in e<lema an<l innammation. LOTEMAX Ointment (lotepre<lnol etabonate ophthalmic ointment) 0.5 percent is
`also available for the treatment of post-operafive innamma ion an<l pain following ocular surgery.
`Dosage and Administration
`Invert close<l bot le an<l shake once to fill fip before instilling <lrops. Apply one or two <lrops of LOTEMAX GEL into the
`affecte<l eye(s) four fimes daily aner surgery and continuing throughout he first two weeks of the post-operative perio<l.
`Dosage Forms and Strengths
`Topical ophthalmic gel: lotepre<lnol etabonate ophthalmic gel 0.5 percent.
`Important Risk Information about LOTEMAX GEL
`Contraindications:
`LOTEMAX GEL is conlrain<licate<l in most viral <liseases of he co mea and conjunctiva including epi helial herpes simplex
`keratifis (<len<lritic keratifis). vaccinia, an<l varicella, an<l also in mycobacterial infec ion of the eye an<l fungal <liseases of
`ocular structures.
`
`Warnings and Precautions
`Intraocular pressure (lOP) increase- Prolonge<l use of corticosteroids may result in glaucoma wi h damage to the opfic
`nerve. <lefects in visual acuity an<l fields of vision. If this product is use<l for 10 <lays or longer. lOP shoul<l be monitore<l.
`
`Cataracts- Use of corticosteroi<ls may result in posterior subcapsular cataract formation.
`
`Delaye<l healing - use of steroids aner cataract surgery may <lelay healing an<l increase the inci<lence of bleb formafion
`and occurrence of perforations in hose with diseases causing co meal an<l scleral thinning. The inifial pre scrip ion an<l
`renewal of he medication or<lershould be made by a physician only aner examination of the pa ientwith he aid of
`magnificafion.
`
`Bacterial infec ions - Prolonged use of cor icosteroids may suppress he host response and thus increase the hazard of
`secondary ocular infection. In acute purulent condifions. steroids may mask infection or enhance existing infecfions.
`
`Viral infecfions- Use of cor icosteroid medicafion in the treatment ofpafients with a history of herpes simplex requires great
`caution. Use of ocular steroids may prolong he course and exacerbate the severity of many viral infections of the eye
`(including herpes simplex).
`
`Fungal infec ions - Fungal infec ions of the cornea are particularly prone to develop coincidentally with long-term local
`steroid applicafion. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been
`used or is in use.
`
`Contact lens wear - Patients should not wear contact lenses when using LOTEMAXGEL
`
`Adverse Reactions
`The most common ocular adverse drug reactions were anterior chamber innammafion (five percent). eye pain (two percent)
`an<l foreign body sensa ion (two percent).
`
`Please see full oresq jbjpg jgformatjog(155.2 KB, PDF) for LOTEMAX Gel.
`About BESIVANCE
`Besivance® (besinoxacin ophthalmic suspension) 0.6 percent is a quinolone antimicrobial indicated for the treatment of
`bacterial conjuncfivifis caused by suscep ible isolates of the following bacteria: Aerococcus viridans• . CDC coryneform
`group G. Corynebacterium pseudo<liphtheri icum•. Corynebacterium striatum• . Haemophilus innuenzae. Moraxella
`catarrhalis*, Moraxella lacunata•. Pseudomonas aeruginosa•. Staphylococcus au reus. Staphylococcus epidermidis,
`Staphylococcus nominis·. staphylococcus lugdunensis·. staphylococcus warneri·. streptococcus mi is group.
`Streptococcus oralis. Streptococcus pneumoniae. Streptococcus salivarius· *Efficacy for his organism was stu<lie<l in fewer
`than 10 infecfions.
`
`Dosage and Admini~tration
`Ins ill one <lrop in the affected eye(s) hree fimes a day, four to twelve hours apart lor seven <lays. (2)
`
`Dosage Forms and Strengths
`7.5 mL size bot le filled with five mL ofbesinoxadn ophthalmic suspension. 0 .6 percent(3)
`
`Important Risk Information about BESIVANCE
`Contraindications:
`None
`
`Warnings and Precautions
`Topical Ophthalmic use Only.
`Growth of resistant organisms with prolonged use.
`
`Avoidance of contact lenses. Pafients should not wear contact lenses if hey have signs or symptoms of bacterial
`conjunc ivifis or <luring the course of therapy with Besivance (besinoxacin ophthalmic suspension) 0.6 percent.
`
`Adverse Reactions
`The most common adverse reacfion reported in two percent of patients treated w ith Besivance was conjunc ivai redness.
`
`Please see fiJI! prescUbjng jnformat;on(214.8 KB. PDF) for Besivance.
`About Bausch + Lomb
`Bausch+ Lomb is a leading global eye heal h company hat is solely focused on protecfing, enhancing, and restoring
`people's eyesight. Our core businesses include ophthalmic pharmaceu icals. contact lenses and lens care pro<lucts. and
`opn halmic surgical devices and instruments. we globally <levelop. manufacture aM market one of the most
`comprehensive pro<luct portfolios in our industry, which are available in more than 100 countries. Founde<l in 1853, our
`company is headquartered in Rochester. NY, and employs more than 11,000 people worldwide.
`
`REFERENCES
`1. Bausch & Lomb Incorporated. Data on file. 2009.
`2. Tetz. ASCRS. 2009.
`®I"' are trademarks of Bausch & Lomb Incorporated or its affiliates.
`All other band/product names are lra<lemarks of their respective owners.
`© 2013 Bausch & Lomb Incorporated.
`
`PAGE 3 OF 4
`
`

`
`###
`News Media Contacts :
`Teresa Panas
`Global Pharmaceutical Communicatons, Bausch + Lomb
`(973)-360~382 or teresa.panas@bausch.com
`Jeanie Herbert
`Global Surgical Communica ions, Bausch+ Lomb
`(949) 521 -7948, (714) 325-3584 (mobile) or jeanie herbert@bausch.com
`Tad Heitmann
`BioComm Networ1<on behalf of Bausch + Lomb
`(714) 273-2937 or theitmann@BioCommNetwor1< com
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