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`Home ... Newsroom 2013 Archive Bausch + Lomb Launches PROLENSA™ And Showcases Innovative 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™ 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 of the VICTUS™ Femtosecond Laser Platform
`ROCHESTER, NY — Bausch + Lomb, the global eye health company, will debut PROLENSA™ (bromfenac ophthalmic
`solution) 0.07 percent, its newly approved nonsteroidal anti-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 Refractive Surgery (ASCRS) Symposium (San Francisco, Calif., April
`19-23). Attendees will also be able to participate in surgical equipment demonstrations, attend scientific symposia, a CME
`event and booth talks, and see two dozen scientific podium presentations and posters related to Bausch + Lomb’s
`ophthalmic pharmaceutical and surgical offerings.
`New Products and Solutions – The More You Look, The More You See
`Among its wide range of pharmaceutical and surgical solutions, Bausch + Lomb will debut the recently approved
`PROLENSA (bromfenac ophthalmic solution) 0.07 percent prescription eye drop, a new 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 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 penetration. The advanced formulation allows for a lower
`concentration of the active ingredient, bromfenac, while maintaining the convenience of once daily dosing. PROLENSA will
`be available in 1.6ml and 3ml bottle sizes.
`
`The company also will highlight LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5 percent gel drop formulation, a
`new topical corticosteroid formulation in its line of loteprednol etabonate C-20 ester corticosteroid-based ophthalmic
`products. Introduced in January, LOTEMAX Gel is indicated for the 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 concentration of
`loteprednol is delivered in every drop, with no shaking to resuspend the drug required.
`Bausch + Lomb will offer demonstrations of its cutting edge surgical platform, the VICTUS™ femtosecond laser platform, by
`appointment, which can be scheduled at the Bausch + Lomb booth (#1926). And, with the recent announcement of a global
`distribution agreement with Leica Microsystems, the Bausch + Lomb booth will feature several Leica Microsystems
`ophthalmic microscopes.
`The company will also showcase the latest additions 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 Descemet’s Membrane
`Endothelial Keratoplasty procedure developed by Thomas John, M.D., in Chicago, Ill. The instruments will be available for
`purchase at the Bausch + Lomb booth (#1926).
`Scientific Symposia
`Bausch + Lomb is sponsoring three scientific symposia including the following:
`• “A New Advancement in the Ocular Delivery of Loteprednol Etabonate,” on Saturday, April 20 from 7 – 9 p.m. PDT at the
`InterContinental Hotel’s Grand Ballroom.
`• “Hot Topics in Cataract Surgery: Femtosecond & IOL Controversies,” on Sunday, April 21 from 5 – 6:30 p.m. PDT at the
`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 of interactive programs in its booth covering the future 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, Mark Packer and Jeff Whitman. The talks begin on Saturday,
`April 20 and continue through Monday, April 22. A full schedule will be available at the Bausch + Lomb booth (#1926).
`In addition, the company’s chief medical officer, Cal Roberts, M.D., and other members of the Global Medical Affairs team
`will be on hand to engage the ophthalmic community and answer questions.
`CME Events
`Bausch + Lomb is supporting, “Knocking Down Inflammatory Barriers to Success in Refractive Cataract Surgery,” a CME
`event featuring 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 take place on Saturday, April 20 from 5:30 – 6:30 p.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 the new enVista® hydrophobic
`acrylic intraocular lens, the first and only IOL approved in the U.S. with labeling that states: “No glistenings of any grade
`1,2
`were reported for any subject at any visit in the clinical study”.
`
`The schedule for all Bausch + Lomb podium presentations and posters is as follows:
`Saturday:
`Endl MJ, et al. “Assessment of Corneal Flap Thickness Precision with New Femtosecond Laser.” [ASCRS Posters P2:
`Keratorefractive: KIOSKS (Moscone) Saturday, April 20, 8 a.m. – 5 p.m. PDT]
`
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`SENJU EXHIBIT 2211
`LUPIN v. SENJU
`IPR2015-01099
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`Majmudar P, et al. “Safety of Besifloxacin Ophthalmic 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]
`Rajpal R, et al. “Resolution of Anterior Chamber Cells and Flare with Loteprednol Etabonate 0.5 percent Gel: New
`Treatment for Post-Cataract Inflammation and Pain.” [ASCRS Posters P1: Intraocular Surgery (Cataract and Refractive):
`KIOSKS (Moscone) Saturday, April 20 8 a.m. – 5 p.m. PDT]
`Stephenson P, et al. “Clarity of Vision with New Hydrophobic Acrylic IOL.” [ASCRS Posters P1: Intraocular Surgery: KIOSKS
`(Moscone) Saturday, April 20, 8 a.m. – 5 p.m. PDT]
`Stodulka P, et al. “High-Volume Use of Femtosecond Laser-Assisted Cataract Surgery.” [ASCRS Posters P1: Intraocular
`Surgery: KIOSKS (Moscone) Saturday, April 20, 8 a.m. – 5 p.m. PDT]
`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 – 2:30 p.m. PDT]
`Chu R, Pepose JS, Qazi MA et al. “Comparison of NEI-RQL-42 and SVI Quality of Life Measures After Bilateral Implantation
`of 3 FDA-Approved Presbyopia-Correcting IOLs at 6-months.” [ASCRS Paper Session 1-C: Intraocular Surgery Presbyopia-
`Correcting IOLs: Room 121 (Moscone), Saturday, April 20, 1 – 2:30 p.m. PDT]
`Dell SJ et al. “Comparison of Free-Floating Capsulotomy - Rate of 2 Femtosecond Laser Systems for Cataract Surgery.”
`[ASCRS Paper Session 1-B: Intraocular Surgery Femtosecond Laser: Room 130 (Moscone), Saturday, April 20, 1 – 2:30
`p.m. PDT]
`Stephenson P et al. “Use of Intraoperative Wavefront Aberrometer with New Aspheric Hydrophobic Acrylic IOL.” [ASCRS
`Paper Session 1-D: Intraocular Surgery Power Calculations: Room 123 (Moscone), Saturday, April 20, 1 – 2:30 p.m. PDT]
`Chee S, Ti S et al. “Early Visual Outcomes of First 100 Cases of Femtosecond Laser-Assisted Cataract Surgery at
`Ophthalmic Institution in Singapore.” [ASCRS Paper Session 1- G: Intraocular Surgery Femtosecond laser: Room 120
`(Moscone), Saturday, April 20, 3 – 4:45 p.m. PDT]
`Daya SM, Nanavaty MA, Espinosa M et al. “Ultrasound Power, Translenticular Hydrodissection and Lens Fragmentation 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. “Prospective Randomized Evaluation of Bilateral Implantation of 3 FDA-Approved Presbyopia-
`Correcting IOLs at 6-months.” [ASCRS Paper Session 1-I: 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. “Evaluation of Visual Metrics Using OQAS After Bilateral Implantation of Accommodating
`or Multifocal IOLs.” [ASCRS Paper Session 1-I: Intraocular Surgery Presbyopia-Correcting IOLs: Room 130 (Moscone),
`Saturday, April 20, 3 – 4:30 p.m. PDT]
`Sunday:
`Kandavel R, Colvard M et al. “Seven-Year Visual Acuity Outcomes with 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-occlusion Surge with Advanced Fluidics.” [ASCRS Paper Session 2-E: Intraocular
`Surgery Phaco Technology: Room 125 (Moscone), Sunday, April 21, 8– 9:30 a.m. PDT]
`Schechter B et al. “Improved Surgical Efficiency with Newer Model Phacoemulsification System.” [ASCRS Paper Session 2-
`E: Intraocular Surgery Phaco Technology: Room 125 (Moscone), Sunday, April 21, 8 – 9:30 a.m. PDT]
`Roberts, C, Stodulka. P. “Improved Surgical Productivity With 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 J et al. “Anterior Capsulotomy Diameter Accuracy and Refractive Outcomes using Femtosecond Laser.” [ASCRS
`Paper Session 2-A: Intraocular Surgery Femtosecond Laser: Room 120 (Moscone), Sunday, April 21, 8– 9:30 a.m. PDT]
`Haq F, Whitman J et al. “Corneal Flap Creation with 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 R et al. “Burst Hemiflip Approach to Phacoemulsification: Effect of Stable Chamber Fluidics on Nuclear
`Disassembly and Removal.” [ASCRS Paper Session 2-O: Intraocular Surgery Phaco: Room 121 (Moscone), Sunday, April
`21, 3– 4:30 p.m. PDT]
`Monday:
`Guedj M, Monnet D et al. “Prospective Evaluation of New Hydrophobic Toric IOL.” [ASCRS Paper Session 4-C: Intraocular
`Surgery Toric IOLs: Room 125 (Moscone), Monday, April 22, 8 – 9:30 a.m. PDT]
`Malyugin BE, Golovin AV et al. “Clinical Outcomes with New Hydrophobic Acrylic IOL.” [ASCRS Paper Session 4-F:
`Russian Papers: Room 125 (Moscone), Monday, April 22, 8– 9:45 a.m. PDT]
`Nichamin LD et al. “Rotational Stability of New Foldable One-Piece Hydrophobic Acrylic IOL.” [ASCRS Paper Session 4-B:
`Intraocular Surgery Monofocal IOLs: Room 121 (Moscone), Monday, April 22, 8 – 9:30 a.m. PDT]
`Packer M et al. “Implantation of Glistening-Free One-Piece Hydrophobic Acrylic IOL in Cataract patients: Safety and Visual
`Outcomes.” [ASCRS Paper Session 4-H: Intraocular Surgery Monofocal IOLs: 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 anti-inflammatory drug
`(NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have
`undergone cataract surgery. PROLENSA is an advanced formulation of BROMDAY® (bromfenac ophthalmic solution) 0.09
`percent that provides proven once-daily efficacy with a lower concentration of bromfenac.
`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 (bromfenac ophthalmic solution) 0.07 percent.
`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(53.5 KB, PDF) for PROLENSA.
`About LOTEMAX GEL
`LOTEMAX® GEL is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular
`surgery. Loteprednol etabonate, the active ingredient in LOTEMAX GEL, was first approved as an ocular anti-inflammatory
`
`Page 2 of 4
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`

`
`agent by the FDA in 1998 as LOTEMAX (lotepredenol etabonate ophthalmic suspension) 0.5 percent, indicated for the
`treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior
`segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis,
`iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable
`diminution in edema and inflammation. LOTEMAX Ointment (loteprednol etabonate ophthalmic ointment) 0.5 percent is
`also available for the treatment of post-operative inflammation and pain following ocular surgery.
`Dosage and Administration
`Invert closed bottle and shake once to fill tip before instilling drops. Apply one or two drops of LOTEMAX GEL into the
`affected eye(s) four times daily after surgery and continuing throughout the first two weeks of the post-operative period.
`Dosage Forms and Strengths
`Topical ophthalmic gel: loteprednol etabonate ophthalmic gel 0.5 percent.
`Important Risk Information about LOTEMAX GEL
`Contraindications:
`LOTEMAX GEL is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex
`keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of
`ocular structures.
`Warnings and Precautions
`Intraocular pressure (IOP) increase - Prolonged use of corticosteroids may result in glaucoma with damage to the optic
`nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.
`Cataracts - Use of corticosteroids may result in posterior subcapsular cataract formation.
`Delayed healing - Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation
`and occurrence of perforations in those with diseases causing corneal and scleral thinning. The initial prescription and
`renewal of the medication order should be made by a physician only after examination of the patient with the aid of
`magnification.
`Bacterial infections - Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of
`secondary ocular infection. In acute purulent conditions, steroids may mask infection or enhance existing infections.
`Viral infections – Use of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great
`caution. Use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of the eye
`(including herpes simplex).
`Fungal infections - Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local
`steroid application. 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 LOTEMAX GEL.
`Adverse Reactions
`The most common ocular adverse drug reactions were anterior chamber inflammation (five percent), eye pain (two percent)
`and foreign body sensation (two percent).
`Please see full prescribing information(155.2 KB, PDF) for LOTEMAX Gel.
`About BESIVANCE
`Besivance® (besifloxacin ophthalmic suspension) 0.6 percent, is a quinolone antimicrobial indicated for the treatment of
`bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans*, CDC coryneform
`group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella
`catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis,
`Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group,
`Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius* *Efficacy for this organism was studied in fewer
`than 10 infections.
`Dosage and Administration
`Instill one drop in the affected eye(s) three times a day, four to twelve hours apart for seven days. (2)
`Dosage Forms and Strengths
`7.5 mL size bottle filled with five mL of besifloxacin 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. Patients should not wear contact lenses if they have signs or symptoms of bacterial
`conjunctivitis or during the course of therapy with Besivance (besifloxacin ophthalmic suspension) 0.6 percent.
`Adverse Reactions
`The most common adverse reaction reported in two percent of patients treated with Besivance was conjunctival redness.
`Please see full prescribing information(214.8 KB, PDF) for Besivance.
`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.
`
`
`REFERENCES
` 1. Bausch & Lomb Incorporated. Data on file, 2009.
`2. Tetz. ASCRS. 2009.
`®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
`All other band/product names are trademarks of their respective owners.
`© 2013 Bausch & Lomb Incorporated.
`
`Page 3 of 4
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`# # #
`News Media Contacts:
`Teresa Panas
`Global Pharmaceutical Communicatons, Bausch + Lomb
`(973)-360-6382 or teresa.panas@bausch.com
`Jeanie Herbert
`Global Surgical Communications, Bausch + Lomb
`(949) 521-7948, (714) 325-3584 (mobile) or jeanie.herbert@bausch.com
`Tad Heitmann
`BioComm Network on behalf of Bausch + Lomb
`(714) 273-2937 or theitmann@BioCommNetwork.com
`
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