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`Home >
`>Newsroom > 2013 Archive > Bausch + Lomb Launches PROt.ENSA"' And Showcases Innovative Additions
`To ts Surgical ProductPortfolio AtTheASCRS Annual Meeting
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`Bausch + Lomb Launches PROLENSA"" and Showcases Innovative
`Additions to its Surgical Product Portfolio at the ASCRS Annual Meeting
`us. oerntor New Once-Daiy PROLBISA“ (bromfenac optttrtalnric solution) 0.07 percent
`special Cataract and Rerractive surgical Srites on Display, with Feattled
`Demtrations ot the VlCTUS" Femtosecond Laser Plattorm
`ROCHESTER, NY— Bausch + Lomb, the global eye health corrpany,wilI debut PROLENSA"' (brorrfinac ophthalmic
`solution) 0.07 percent, is newly approved nonsbroithl anti-inlanvmbry ophthalnic solution, artd highlight innovative
`additiorls I) is cormrehensive line ofophthalrnic sttrgil instruments and therapeutics at is boottl (#1926) during the
`rpcorrirg Annual Arrrerican Societyolcahractand Reiacive surgery (ASCRS) Synposiurrr (San Francisco, Calit, April
`1923). Attendees will also be able I) participate in surgil equiprrtertt demonstratiorts, attend scieniic symposia, a CME
`eventand boolr tails, and see two dozen scientific poditln presenhions and posbrs related I) Bausch + Lorrlfs
`oprttnalrnic ptrarrrlaoeuical and surgical otrerings.
`llewProttrctsarIdSoIlions—1TteIloreYouLoolt,TheMoreVmrSee
`Arrtong is wide range ofphamtaceutical and surgicd solutions, Bausch + Lomb wil debutthe recently approved
`PROl_ENSA (brorrflnac ophthalrrric solution) 0.07 percent prescription eye drop, a rtew once-daily nonwroidal anti—
`inlamrmbry drug (NSAID) for the treatment of posbperaive inlamrnation and reduction ofocular pain in paiens who
`have undergone cahlact surgery. PROLENSA is an advanced bmrulation of BromdayO (bromknac ophthalmic solution)
`0.09 percentthat provides powertirl artd rapid resolutiort otinlammatiort and pain from cahract surgery by leveragitg the
`tltique potency otthe bromknac ntolecule and etlective ocular penetration. The advmced tomtulation allows hr a lower
`concerrlaion otlie active ingredient, bromtznac, whie maintaining the convenience ofonce daily dosing. PROLENSA will
`be avaiable in 1.6mI and 3m! bottle sizes.
`
`The corrpany also will highlight LOTEMAXD (lobprethol etabonat-3 ophthalmic gel) 0 5 percentgel drop brrrtulaion, a
`new bpical corticosteroid lomrulation in is Iirre of lobprednol etabonate C-20 estercorticostaroid-based ophtralmic
`products. htroduced in January, LO1EMAXGel is indiahd lorthe treatment ofpost—operative ittlarrvnation and pain
`bllowitg ocular surgery. The unique LOTEMAX Gel (top brmulation is engineered b adhere b the octrlar strrlace lttrough
`is rrrtrcoadhesive technology. LOTEMAXGeI also provides dose unibrmity, ensurirtg tttata consishnt concentration of
`lobpremol is delivered in every drop, with no sharing it restrspend the dmg required.
`Bausclt + Lorrlb will oler demonstrations of is cutting edge surgical plationn, the vrc1us'- terrmsecond laser platform, by
`wpoittrtent, which an be scheduled atthe Battsch + Lorri) booth (#1926). And, with the recerttannouncemertt ofa global
`distribution agreementwith Leica Mcrosysbms, Ire Bausch + Loni) booth will battle several Leica licrosyfims
`ophthairiic microscopes,
`The corrpany will also showcase the labstadditiorrs b its Bausch + Lomb Sbrzb industry—leating ophthalnic instrument
`portblio tor reiactive, cahract and vitreo-retinal surgery. This will include a specialized set ol instrurrtents designed
`speciticdly b cormlement Ierrtbsecond laser procedures and a set otinstrumentation torthe new Descemefs Merrbrane
`Endolhelial Keratrplasty procedure developed by Thonas John, M D, in Chicago, It. The irlstrurnens will be available for
`purchase atlte Bausch + Lomb booth (81926).
`Scierrtilic Symposia
`Bausch + Lorrb is sponsoring three scientific syrrlposia including the bllowing:
`- ‘A New Advancement in the Ocular Delivery of Lotaprednol Etabortatef on Sattrrday, April 20 tiom 7 — 9 p m. PDTatttre
`hbroominentat Hobl's Grand Ballroom.
`- ‘Hot Topics in cahract Surgery: Fembsecond & IOL Controversies,‘ on Sunday, April 21 lrom 5 — 6:30 p m. PDTatthe
`hbrcontinental Hobl's Grand Ballroom.
`-"Selecing an NSADiorSurgery:WhatReally Matt-:rs?,'ort Sunday, April t9lrom730—930 p m. PDTatthe
`hbroominentat Hobl's Grand Ballroom.
`Booth Talrs
`Bausch + Lorrb will host a series otinbractive prograns in is boolt covering the tuttle ofcataract stlgery, product
`innovation and practice management These talts wil be led by an impressive and diverse group ofhighly regarded
`spealllers, including Drs. Rob Weinsbclt, John Sheppard, Mark Packer and Jellwhitrnan. The talts begin on Saturday,
`April 20 and corttinue Itrough Monday, April 22. Alul schedule will be available atthe Bausch + Lorri) booth (#1926).
`h addition, the corrvamrs chiefmedical otlicer, Cal Roberts, M D_ artd other members ofthe Global Medit:aI Allairs barn
`will be on hand I) engage the ophthainic community and answer questions,
`CME Events
`Bausch + Lorri) is supporting, ‘Knocking Down Ittlarrmabry Barriersb Success in Reiactive Cahract Surgery,‘ a CME
`event featuring rnoderabr Teny lGm, M D.; and faculty, David F. Chang, M D.; Uday Devgm, M D.; Francis 8. Mah, MD.;
`and Keir Warren, M D. The event is scheduled b latte place on Saturday, April 20 tom 5:30 — 6 30 pm., with registration
`openirg at 5 p m.
`Scierrtilic Potirlrr Presentations and Posters
`Bausch + Lorrb will present 23 podium presenhtions and e-po$rs, including several on the new enlfistao hydrophobic
`acrylic ittraocular lets, the first and any IOL approved in Ire U.S.with labeling thatsht-as: ‘No glisbnings otany grade
`were reported hr any subject at any visit it the clinical study'.‘-’
`The schedule hr all Bausch + Lomb podium preserthtions and posters is as follows:
`Saturdax
`Endl MJ, etal. 'AssessrnentotComeal Flap Thidrness Precision with New Fembsecond Laser.‘ [ASCRS Posters P2:
`Kerabretracive: KIOSKS (Moscone) Saturday, April 20, 8 am. — 5 p rrt. PDT]
`
`Page 1 of 4
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`SENJU EXHIBIT 2211
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`Majrnudar P, et al. ‘Safety of Bosilloxacin Ophlialmic Suspension 0.6 percent in Cahract Surgery Patients: Prospective
`Surveillance Strdy.‘ [ASCRS Posters P1: htraocular Surgery (Cataract and Reiactive): KDSKS (Moscone) Salrrday, April
`208a.m.—5 pm.PDT]
`Rajpal R, etal_ "Resolution ofAnbrior Chamber Cells and Flare with Lohprednol Etabonab 0 5 percent Gel: New
`Treatmenttor Post-Cataract htlamnnion and Pain.‘ [ASCRS Posbrs P1: Intraocular Surgery (Cataract and Refracive):
`KIOSKS (Moscone) Salrrday, April 20 8 a m.— 5 pm. PDT]
`Stephenson P, et al. ‘Clarity ofWsion wilr New Hydrophobic Acrylic l0L_' [ECRS Posters Pt: htaocular Surgery: KIOSKS
`(Moscone) Satrrday, April 20, 8 am. — 5 p m. PDT]
`Sbdullra P, et al. ‘High-Volurne Use oi Fenbsecond Laser—A$ist-3d Cataract Surgery.‘ [ASCRS Posters P1: htraocular
`Surgery: KDSKS (Moscone) Salrrday, April 20, 8 a m. — 5 p_m_ PDT]
`Ang RT et al. ‘Prospective Comparison oft Acconinodating and 2 Mulitocal l0Ls: \fisua| Acuity, Reiactive Oubome and
`Contrast
`at Year 1.‘ [ASCRS Paper Session 1-C: htraocular Surgery Presbyopia-Conecing l0l.s: Room 121
`(Moscone), Sahrday, April 20, 1 -2230 pm. PDT]
`Chu R, Pepose JS, Oazi MA et al. ‘Comparison of NEI-R(J.—42 and SVI Quality of Life Measrles Alter Bilateral lrnplantaion
`of 3 FDA-Approved Presbyopia-Correcing K)l.s at 6-rnonIis.' [ASCRS Paper Session 1-C: hiaocular Surgery Presbyopia-
`Correding lOLs Room 121 (Moscone), Satrrday, April 20, 1 — 2:30 p m. PDT]
`Dell SJ et al. 'Cornparison of Free-Floating Capsulobrny - Rate of 2 Fembsecond Laser Sy$rns hr Cahract Surgery.‘
`[ASCRS Paper Session 1-B: lnlraoculz Surgery Fernbsecond Laser. Room 130 (Moscone), Saturday, April 20, 1 — 2:30
`P1"- P01]
`Stephenson P et al. ‘Use of htraoperaive WaveiontAberromebrwiII New Aspheric Hydrophobic Acrylic l0l..' [ASCRS
`Paper Session 1-D: hiaocular Surgery Power Calculaions: Room 123 (Moscone), Satrrday, April 20, 1 — 2:30 p m. PDT]
`Chee S,T'r S etaI.‘EarlyVisual Outcomesofl-‘irst 100 CasesotFerrIosecond Laser-Assisted Cataractsurgeryat
`Ophthalmic hstituion in Siigaporef [ASCRS Paper Session 1- G: Intaocular Surgery Ferntosecond laser. Room 120
`(Moscone), Salrrday, April 20, 3 — 4:45 pm. PDT]
`Daya SM, Nanavaty MA, Espinosa M et al. 'U|Iasound Power, Translenicular Hydrodissection and Lens Fragmenhtion in
`Ferrmsecond laser Cahract Surgery.‘ [ASCRS PaperSession 1-G: htaocular Surgery Fernbsecond laser: Room 120
`(Moscone), Salrrday, April 20, 3 — 4:45 pm. PDT]
`Pepose JS, Oazi MA et al. ‘Prospective Randonized Evaluation of Bilateral Irplanhtion of3 FDA—Approved Presbyopia—
`Correcting l0Ls at 6-monIrs.' [ASCRS Paper Session 14: htraocular Surgery Presbyopia-Correcting K)Ls: Room 130
`(Moscone), Salrrday, April 20, 3-430 p m PDT]
`Qazi MA, Chu R, Pepose JS et al. ‘Evduation of\fisua| Merits Using OQAS Alter Bilabral knplanhion ofAccomrnodaing
`or Multibcal lOLs.' [ASCRS Paper Session 1-I: htraowlar Surgery Presbyopia-Correcting l0Ls: Room 130 (Moscone),
`Saturday, April 20, 3 — 4 30 p_m_ PDT]
`Sunday:
`Kandavel R, Colvard M et al. ‘Seven-Yea Visual Amity Outcomes with an Accornmodaing lOl..' [ASCRS Paper Session 2-
`C: Intraocular Surgery Presbyopia-Correcing l0Ls: Room 123 (Moscone), Sunday, April 21 , 8- 9:30 am. PDT]
`Page TP et al. 'Managernentot Post-ocdusion Surge with Advanced Fluidirs‘ [ASCRS Paper Semion 2—E: htraocular
`Surgery Phaco Technology Room 125 (Moscone), Sunday, April 21, 8- 9 30 am. PDT]
`Schechbr B etaI_ ‘lnproved Surgil Eliciency with Newer Model Phacoemulsiir-aion System.‘ [ASCRS Paper Session 2-
`E lntraocrrlar Surgery Phaco Technology Room 125 (Moscone), Sunday, April 21, 8 — 9 30 am. PDT]
`Robers, C, Sbdullra. P. ‘Inproved Surgical Producivitylllhth lncorporaion of Ferrhsecond Laser in Cahract Surgery.‘
`[ASCRS Paper Session 2-k Intraoculz Surgery Ferrmsecond Laser. Room 120 (Moscone) 8 - 9.30 am. PDT]
`Whitman J et al. ‘Anterior Capsulobmy Diamebr Accuracy and Refractive Oubornes using Femtosecond |_aser.‘ [ASCRS
`Papersession 2—A: lniaocularsurgery Fernhsecond Laser’. Room 120 (Moscorre), Sunday, April 21, 8- 9 30 am. PDT]
`Haq F, Vlniitnan J et al. ‘Corneal Flap Creation wilh New Fernbsecond Laser used During LASIK' [ASCRS Paper Session
`2-J: lntraocula Surgery Kerabrefractive l.AS IC Room 123 (Moscone), Sunday, April 21, 1 — 2 30 pm. PDT]
`Wallace R et al. ‘Burst Hemilip Approach b Phacoernulsitication: Etkct of Stable Charrber Fluidics on Nuclear
`Disassembly and Removal.‘ [ASCRS Paper Session 2-0: htraocular Surgery Phaco: Room 121 (Moscone), Sunday, April
`21 , 3- 4:30 p rn PDT]
`Monday
`Guedj M, Monnet D et al. ‘Prospective Evaluation of New Hydrophobic Toric lOL_‘ [ASCRS Paper Session 4-C: hiaocular
`Surgery Toric lOLs: Room 125 (Moscone), Monday, April 22, 8 — 9:30 a m. PDT]
`Malyugin BE, Golovin AV et al. 'C|inicd Outcomes wili New Hydrophobic Acrylic IOL_' [ASCRS Paper Session 4-F:
`Russian Papers: Room 125 (Moscone), Monday, Apri 22, 8- 9:45 am. PDT]
`Nicharnin LD et al. ‘Rotaional Shbiity of New Foldable One-Piece Hydrophobic Acrylic K1.‘ [ASCRS Paper Sesion 4-B:
`htraocular Surgery Monobcal l0l.s: Room 121 (Moscone), Monday, April 22, 8 -9 30 a_m_ PDT]
`Packer M et al. ‘Implantation of Glishning-Free One-Piece Hydrophobic Acrylic IOL in Cataract paients: Safety and \fisual
`Outcomes.‘ [ASCRS Paper Session 4-H: htraoculz Surgery Monofocal K15: Room 123 (Moscone)_ Monday, April 22, 10
`— 11 30 a_m_ PDT]
`About PROLENSA
`PROLENSA“ (brornienac ophlialrric solution) 0 07 percent is a once-daily, hpical nonsleroidal anti-inlamnnbry dmg
`(NSAID) imitated hr the ieatnent ofposbperaive inllanlnation and reducion ofocular pair ii paients who have
`undergone tarad surgery. PROLENSA is an advanced torrnrlaion of BROMDAYD (bromienac ophlhalrric soluion) 0.09
`percent hat provides proven once-daily elicacy with a lower concentation of brornknac
`Dosage and Arininistration
`hstill one drop inb Ire aflecbd eye once daily beg'nning one day prior!) surgery, continued on he day of surgery, and
`Iirough the irst 14 days postsurgery.
`Inportant Risk Intomiation about PROLENSA (bromfenac ophhalmic solution) 0 07 percent
`Warniigs and Precautions
`Sulih a|lerg'c reactions
`Slow or delayed healing
`Pobntial for
`hcreased bleeding ofocular issues
`Corneal eli-zcs, including Ireratitis
`Conhct lens wear
`Adrerse Reactions
`The mod corrlnonly reported adverse reactions in three — eight percent of patients were, anbrior charrber inlarnrnation,
`foreign body sensation, eye pain, phobphobia, and blurred
`Please see (535 KB. PDF) for PR0!-ENS/t
`Abour LOTEMAX GEL
`LOTEMAXD GEL is a corticosteroid iidicahd hr lie ieatment ofposbperaive inflammation and pain bllowing oculz
`surgery. Lot-zprednol etabonate, the acive ingredientin LOTEMAXGEL, was irst approved as an ocular anti—inIamrnabry
`
`Page 2 of 4
`
`

`
`agent by tile FDA in 1998 as LOTHIAX (lobprederlol etabonal-3 ophthalnic sulspension) 0 5 percent, ilrirabd br ttle
`teatrnent ofsteroid-responsive inlarnmabry condiiorls oftlle palpebral and butbar corljunciva, conlea, and anterior
`segment ofttle globe, such as allergic conjuncivitis, acne rosacea, superficial punchb lreraiis, herpes zofir lleuaitis,
`iritis, cyditis, selechd infecive conjuncivitides, wherl Ile inherent hazard of sbroid use is accepbd b obta’n an advisdlle
`dirrlinutiorl in edema and irltlanvrlatiorl. LOTEMAX Oirltrlent (lobpredrlol ehborlab ophthalrrlic ointment) 0 5 perceult is
`also available brthe treatnentof post-operaive intlanlrnation and pain illlowing ocular surgery.
`Dosage arld Adninistration
`hvert closed bottle arld shake once to tilt tip before irustillirlg drops. Apply one ortwo drops of LOTEMAXGEL inb Ile
`atlecbd eye(s) bur times daily alter surgery arld coniluing tllrougtlouttlle firsttwo weells ollle pod-operative period.
`Dosage Fornls and Strenglls
`Topical ophilalmic gel: loteprednol etaborlate ophllalmic gel 0 5 percent.
`Inpoutant Rk hlcrmation about LOTEMAX GEL
`Contrainuications
`LOTEMAXGEL is containdicaled in rrlost viral diseases otthe cornea and conjunctiva indudirlg epitllelial herpes sinplex
`tleratitis (dendriic keraitis), vaccinia, arld varicella, arld also in mycobaderial infection ofttle eye and ilrlgal diseases of
`ocular strudures.
`
`Warnilp and Precautions
`htraocular pressure (IOP) increase — Prolonged use ofcorticosteroids may result in glaucoma will danlage to ttle optic
`nerve, defects in visual acuity and tields ofvision. lltlis product is used hr 10 days or longer, lOP should be monibred.
`Cataracts - Use of corticosbroids may result in pofirior subcapsular cataract bnmion.
`Delayed llealirlg - Use ofsteroids atbr cahract surgery may delay healing and increase Ile incidence of bleb fornntion
`and occurrerlce of perforaions in tllose with diseases causirlg corneal and scleral thinning. The iniial prescription arld
`renewal ofIle nledicalion orderstlould be made by a physician orllyatlerexamilation oflle patientwilh the aid of
`rrngnitiion.
`Bacurial ini-actions - Prolonged use of corticosbroids rmy suppress the host resporlse and thus increase Ile hazard of
`secondary ocular infecion. h acuh puulent conditions, steroids may mask infection or enhance existing infections.
`\flral infections — Use ofcouticofiroid rrledication in Ile teatmentof patienb will a hisbry ofherpes sinqllex requires geat
`caution. Use ofocular steroids rllay prolong he coulrse and exacerbate the severity of many viral intecions otthe eye
`(including herpes sirrplex).
`Fungal infections - Fungal inbctions otlle corll ae paricularly prone I) develop coincidentally will long-k-lnn locd
`$roid appicaion. Fungus invasion must be considered in any persistent conleal ulceration where a sbroid has been
`used or is in use.
`
`Conhct lens wear - Paiens should notwear contact lenses wtlen usirlg LOTEMAXGEL.
`Adverse Reactions
`The most conlrlon ocular adverse dnlg reactions were anterior charrlber intlarnmation (ive percent), eye pain (two percent)
`and foreign body sensaion (mo percerlt).
`Please see lul (1552 KB, PDF) br LOTEMAX Gel.
`About BESIVANCE
`Besivancefl (besitlcil ophthalmic suspension) 0 6 percent, is a quinolorle antimicuobid indicabd for he treatrllerlt of
`bacterial conjuncivitis used by suscepible isolates ofthe following bacteria: Aerococcus viridans', CDC coryneform
`group G, Oorynebacbriurn pseudodiphtheriticum‘, Oorynebachrium sIiaIlm', Haerrlophilus intluenzae, Moraxella
`cahnhalis', Moraxella lacunata‘, Pseudonlonas aenlginosa', Shlhylococcus aureus, Shphylococcus epidemlidis,
`Staphylococcus horuinis', Staphylococcus |ugdunensis', Shphylococcus wameri', Strepbcoccus mitis goup,
`Stepbcoccus oralis, Stepbcoccus prleurllorliae, Strepbcoccus salivalius' ‘Etficy lorttis organism was stlldied "ll fewer
`Ilan 10 infecions.
`
`Dosage and Auininistration
`hstill one drop in the atleuhd eye(s) ttlee imes a day, burb twelve hours apartforseven days. (2)
`Dosage Fou'nls and Strenglls
`7.5 mL size bottle filled will ive ml. of besiloxacin ophllallnir: suspension, 06 percent (3)
`Inportallt Risk htorrnation about BESIVANCE
`Contrailuicatiouls
`None
`
`Warnilgs and Precautions
`Topical Ophilalmic Use Orlly.
`Growth of resistant organisms wiIl prolonged use.
`Avoidance ofconhct lenses Patients should not we: contact lerlses itthey have sigrls or syrrlptonls of bauhrial
`conjunctivitis orduring the course ofllerapywith Besivanoe (besiloxacin ophthalmic suspension) 0 6 percent.
`Adverse Reactions
`The rllost conlnon adverse reaction reported in M0 percent of patient treabd with Besivance was conjlllcival redness.
`Please see Q14.8 KB, PDF) br Bedvanoe.
`About Bausch + Lomb
`Bausch + Lorrb isa tearing global eye healll company Ilatis solelybcused on prohcing, erlhancing, and resbrirlg
`people's eyes’ght_ Ollr core businesses include ophilalrrlic phamlaceuticals, conhct lellses and lens rare producs, arld
`ophttlalnic surgical devices and instuments. We gobally develop, manufaclue and rmrlletone ofthe lnost
`conprehensive product porillios in our irldustry, which are avaiable in rrlore than 100 counties. Founded in 1853, oulr
`corrpany headquauhred in Rodlesbr, NY, and enploys more Ilal 11,000 people worldwide.
`
`REFERENCES
`1. Ballscll & Loni) hcorporahd. Data on ile, 2009.
`2. Tel; ASCRS. 2009.
`OI" are tadermrlls of Bausctl & Lorrb Incorporated or is atiliates.
`All other barldlproduct names are tradennrls oftheirrespecive owners.
`02013 Ballsctl 8. Lomb Iucorporabd.
`
`Page 3 of 4
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`# # #
`News Med: Contacts
`Teresa Pmas
`Global Phamraceuil Cornrnunicabns, Bausch + Lorri)
`(973}360£382 or teresa ganaflbauschcom
`Jeanie Herbert
`Global Surglzl Comrnunicaions, Bausch + Lorrb
`(949) 521 -7948, (714) 325-3584 (rnobie) or jeanie herbeggbauschcom
`Tad Heiirnann
`Biocomm Network on behalfof Bausch + Lornb
`(714) 2712937m
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`02015 Bausdr & Lorri) Incorporated.
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`All inbrrmiion and materials on his site pertain I) he U_S_ only, ml otherwise indimbd_
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