FOR RELEASE 4/23/2014, Wednesday

Bausch + Lomb Introduces ACTIVATE™ System Control Software
and Showcases Other Advancements in its Broad Product Portfolio
 during the ASCRS Annual Meeting in Boston, MA

ACTIVATE System Control Software Offers Stellaris® and
Stellaris® PC Users Numerous Enhancements

Live Booth Demonstrations of the Stellaris® PC Vision Enhancement System, with Integrated Laser and Software,
and the VICTUS® Femtosecond Laser Platform

FOR RELEASE WEDNESDAY, APRIL 23, 2014

BRIDGEWATER, NJ – Bausch + Lomb, a leading global eye health company, will introduce ACTIVATE™ System Control Software, for the Stellaris® and Stellaris® PC line of phacoemulsification and vitrectomy equipment, and showcase many of its newest technological advancements during the upcoming Annual American Society of Cataract and Refractive Surgery (ASCRS) Symposium in Boston, MA (Apr. 25-29).

A variety of interactive discussions with ophthalmic thought leaders will be held in the Bausch + Lomb booth (#1533). There will be more than two dozen scientific podium and poster presentations that feature the company’s pharmaceuticals, intraocular lenses, and surgical equipment, and two sponsored scientific symposia’s focused on cataract surgery.

New Products Highlighted 

During the course of the “Hot Topics in Cataract Surgery: The Femto-Cataract Procedure,” symposium, Bausch + Lomb will debut the ACTIVATE System Control Software, which adds more than forty additional features and controls to the Stellaris and Stellaris PC platforms. With these enhancements, the Stellaris® and Stellaris® PC can now provide surgeons one of the most advanced and comprehensive phacoemulsification and vitrectomy systems that is available on the market today.

Some of the new features the software makes possible include:

• Digiflow™ - Infusion Control System
• File transportability from Stellaris to Stellaris PC
• Enhanced on-screen user controls and drop-down menus
• Enhanced messaging features for clarity and ease-of-use

The software will also provide Stellaris PC users several additional capabilities including:

• Endoilumination for use during cataract surgery
• 5000 CPM anterior vitrectomy cut rates standard

Live demonstrations of the new ACTIVATE features, as well as the integrated 532nm laser and software recently cleared for the Stellaris PC by the U.S. Food and Drug Administration (FDA) will be held in the Bausch + Lomb booth.

The VICTUS® Femtosecond Laser Platform will also be prominently featured in the company’s booth with live demonstrations available of its progressive capabilities, such as the creation of main and side port incisions in the cornea.

In February, Bausch + Lomb announced the U.S. introduction of BLIS™ Injector System, designed exclusively for use with the enVista® hydrophobic acrylic intraocular lens (IOL), a glistening-free IOL. Developed with input from surgeons around the world, the reusable hand piece and single-use cartridge allows surgeons controlled delivery of the enVista IOL through unmodified phaco incisions as small as 2.2 mm. The BLIS system, in addition to the enVista and TRULIGN™ Toric IOLs, will be on display at the Bausch + Lomb booth. Unlike other standard toric IOLs, TRULIGN Toric has the additional capacity to deliver improved vision across a natural range of focus - from intermediate to distance – delivering a lens for patients who want more out of their toric lens.

Featured products from the company’s pharmaceuticals and consumer health portfolio will include LOTEMAX® gel (loteprednol etabonate ophthalmic gel) 0.5%, indicated for the treatment of post-operative inflammation and pain following ocular surgery; PROLENSA® (bromfenac ophthalmic solution) 0.07%, a 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; and PreserVision® AREDS 2 formula, the first supplement released that exactly matches the updated National Eye Institute (NEI) recommended nutrient formula based on evidence from the AREDS2 2013 Age-Related Eye Disease Study.

The Bausch + Lomb Storz ophthalmic instrument portfolio for refractive, cataract and vitreo-retinal surgery will also be on display and available for purchase at the company’s booth. The MacRae Lasik instrument set, one of the newest additions to this comprehensive line, includes the MacRae Lasik Flap Spatula, MacRae Lasik Marker, MacRae Lasik Speculum and the MacRae Lasek Oval Well. Also available is the Berdahl Gonio Prism Stabilizer, which is used during micro incision glaucoma surgery, and the Desai DSEK Forceps, for insertion of donor tissue during DSEK surgery.

Scientific Symposia
Bausch + Lomb is supporting two scientific symposia that will include:

1. “Hot Topics in Cataract Surgery: The Femto-Cataract Procedure,” led by program chair, Roger F. Steinert, MD, on Sunday, April 27, at the Westin Boston Waterfront Hotel in the Grand Ballroom (concourse level,) with registration beginning at 11:30 a.m. EDT. 
2. “Managing Complex Cataracts – Approaches to Handling Challenging Cases with Techniques and Technology,” led by R. Bruce Wallace, MD, on Sunday, April 27, at the Westin Boston Waterfront Hotel in the Grand Ballroom, with registration beginning at 4:45 p.m. EDT.

Booth Talks
A variety of topics will be addressed by a distinguished group of speakers in the Bausch + Lomb booth throughout the meeting. The talks begin on Saturday, April 26 and continue through Monday, April 28. The schedule of speakers and topics include:

Saturday:
“Stabilizing the Anterior Chamber” at 10 a.m. EDT by Anil M. Shivaram, MD

“Five Benefits of Transitioning to Stellaris® Phaco,” at 11 a.m. EDT by Johnny L. Gayton. MD

“Optimizing Outcomes with VICTUS® and TRULIGN™ Toric,” at 2 p.m. EDT by Y. Ralph Chu, MD

“Improved Control is BLIS™ - with the enVista® IOL,” at 3 p.m. EDT by a. James Khodabakhsh, MD

Sunday:
“A look at the New BLIS™ Inserter with enVista®,” at 10 a.m. EDT by P. Dee G. Stephenson, MD

“Femto-Phaco Chamber Stability During Segment Removal,” at 11 a.m. EDT by Inder Paul Singh, MD

“Challenging Cases We All Face: Presented in 3D” at 11:30 a.m. EDT by Robert J. Weinstock, MD

“How to Fit TRULIGN™ Toric into Your Practice,” at 2 p.m. EDT by Douglas A. Katsev, MD

“Managing TRULIGN™ Toric with TrueVision TrueGuide,” at 3 p.m. EDT by D James Schumer, MD

“Efficiency of the Stellaris® System in the Successful ASC,” at 3:30 p.m. EDT by Barry A. Schechter, MD

Monday:
“The First and Only Toric IOL in the U.S. that Delivers MORE,” at 11 a.m. EDT by Ehsan Sadri, MD

Scientific Podium Presentations and Posters
Bausch + Lomb’s products will be featured in more than 25 podium presentations and e-posters, with several highlighting the VICTUS® Femtosecond laser, enVista® hydrophobic acrylic intraocular lens, TRULIGN™ Toric posterior chamber intraocular lens, Stellaris® PC Vision Enhancement System, and LOTEMAX® Gel (loteprednol etabonate ophthalmic gel) 0.5%.

The full schedule of podium presentations and posters that feature Bausch + Lomb’s products is as follows:

Friday:
Malyugin, Boris E. “First Clinical Experience with Femtosecond Laser-Assisted Cataract Surgery.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].

Auffarth, Gerd U. “Femtosecond Laser-Assisted Cataract Surgery: Effective and Average Phaco Time and Endothelial Cell Loss in Contralateral Comparative Study.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].

Endl, Michael J. “Corneal Flap Analysis of New Short-Pulse Femto-LASIK with Optical Coherence Tomography.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].

Ilyas, Haroon. “Pilot Trial of Loteprednol Etabonate Gel 0.5% at BID Dosing in Cataract Surgery Patients.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].

Schechter, Barry A. et al. “Use of Besifloxacin Ophthalmic Suspension 0.6% in Treatment of Bacterial Keratitis.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].

Stodulka, Pavel. “Combined Laser-Assisted Cataract Surgery with Laser Posterior Capsulotomy and Silicone Oil Removal.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].

Ang, Robert Edward T. “Refractive and Visual Outcomes at Postoperative Year 2 in a Randomized Clinical Comparison of Accommodating and 2 Multifocal IOLs.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].

Qazi, Mutjaba A. “Evaluation of PSF Imaging after Bilateral Implantation of Accommodating or Multifocal IOLs.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].
Shaturova, Marina. “First Experience of Glistening-Free Hydrophobic Acrylic IOL.” [ASCRS e-Poster Session: KIOSKS, Friday, April 25].

Saturday:
Kahn, Baseer. “Clinical Experience with a Novel Femtosecond Laser.” [ASCRS Paper Session: Room 151B, Saturday, April 26, 3:52 p.m. EDT].
Holzer, Mike P. “Femtosecond Laser-Assisted Cataract Surgery: Evaluation of Functional Results in Contralateral Comparative Single-Center Study.” [ASCRS Paper Session: Room 151B, Saturday, April 26, 4:05 p.m. EDT].

Sunday:
Chu, Ralph Y. “Incidence of Free-Floating Capsulotomy and Complications Associated With Use of Novel Femtosecond Laser System for Cataract Surgery.” [ASCRS Paper Session: Room 151B, Sunday, April 27, 1:36 p.m. EDT].

Jackson, Mitchell. “Microincisional Cataract Surgery Advantage in Intraoperative Floppy-Iris Syndrome Cases.” [ASCRS Paper Session: Room 151A, Sunday, April 27, 3:11 p.m. EDT].

Wallace, Bruce R. et al. “Global evaluation of Dual-Linear vs Co-Linear Footpedal Control During Cataract Surgery.” [ASCRS Paper Session: Room 151A, Sunday, April 27, 8:55 a.m. EDT].

Pepose, Jay. “Safety and Efficacy of Novel Presbyopia-Correcting Toric Silicone Posterior Chamber IOL.” [ASCRS Paper Session: Room 152, Sunday, April 27, 2:11 p.m. EDT].

Cornell, Peter. “Prospective Evaluation of New Hydrophobic Acrylic IOL.” [ASCRS Paper Session: Room 150, Sunday, April 27, 3:01 p.m. EDT].

Goldman, David. “Safety and Visual Outcomes of Implantation of Hydrophobic Acrylic IOL in Cataract Patients.” [ASCRS Paper Session: Room 150, Sunday, April 27, 3:06 p.m. EDT].

Khodabakhsh, James. “Visual and Safety Outcomes after Implantation of Single-Piece Hydrophobic Acrylic IOL during Cataract Surgery.” [ASCRS Paper Session: Room 150, Sunday, April 27, 3:11 p.m. EDT].

Monday:
Schechter, Barry. “Surgical Time for Uncomplicated Cataract Procedures on Two Surgical Platforms.” [ASCRS Paper Session: Room 151B, Monday, April 28, 1:06 p.m. EDT].

Feinermann, Gregg. “A New Toric Posterior Chamber IOL for Reduction of Residual Astigmatism Following Phacoemulsification.” [ASCRS Paper Session: Room 151B, Monday, April 28, 8:41 a.m. EDT].

Stephenson, Dee. “Cylinder Prediction Error with Intraoperative Aberrometry vs. Standard Astigmatism Calculator for a New Toric IOL.” [ASCRS Paper Session: Room 151B, Monday, April 28, 9:21 a.m. EDT].

Raviv, Tal. “Refractive Results of Toric IOL Implantation With and Without Intraoperative Aberrometry.” [ASCRS Paper Session: Room 151B, Monday, April 28, 9:26 a.m. EDT].

Tuesday:
Kahn, Baseer. “Comprehensive Review of Femtosecond-Laser Assisted Cataract Surgery.” [ASCRS Course: Room 253B, Tuesday, April 29, 1 to 2:30 p.m. EDT].

Kahn, Baseer. “Refractive Outcomes with a Single-Piece Aspheric Intraocular Lens Following Phacoemulsification Versus Femtosecond Laser Cataract Surgery.” [ASCRS Paper Session: Room 151A, Tuesday, April 29, 1:11 p.m. EDT].

Mertens, Erik L. “Femtosecond Laser-Assisted Cataract Surgery and Its Learning Curve.” [ASCRS Paper Session: Room 151A, Tuesday, April 29, 1:56 p.m. EDT].

Stodulka, Paul. “Femtosecond Laser Arcuate Corneal Incisions: Are They Superior to Toric IOLs in Astigmatic Cornea?” [ASCRS Paper Session: Room 151B, Tuesday, April 29, 8:49 a.m. EDT].

Weinstock, Robert. “Comparison of Conventional Limbal Relaxing Incisions and Femtosecond Laser Arcuate Incisions for Correction of Astigmatism at Time of Cataract Surgery.” [ASCRS Paper Session: Room 151B, Tuesday, April 29, 8:54 a.m. EDT].

Important Risk Information about PROLENSA

Warnings and Precautions

• PROLENSA® contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.  Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
• All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing.  Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
• There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac.  Use with caution in patients who have previously exhibited sensitivities to these drugs.
• There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.  Use with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
• Use of topical NSAIDs may result in keratitis.  Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health.  Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.  Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs suggEDTs that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
• PROLENSA should not be instilled while wearing contact lenses.  The preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact lenses.  Lenses may be reinserted after 10 minutes following administration of PROLENSA.

Adverse Reactions

• The most commonly reported adverse reactions in 3%-8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.

Please see PROLENSA full prescribing information here(53.5 KB, PDF).

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 (5 percent), eye pain (2 percent) and foreign body sensation (2 percent).

Please see LOTEMAX Gel full prescribing information here(155.2 KB, PDF).

BESIVANCE Indication
BESIVANCE® (besifloxacin ophthalmic suspension) 0.6 percent is  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, and Streptococcus salivarius.
*Efficacy for this organism was studied in fewer than 10 infections.

Important Risk Information about BESIVANCE
• BESIVANCE® is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
• As with other anti-infectives, prolonged use of BESIVANCE may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy.
• Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE.
• The most common adverse event reported in 2 percent of patients treated with BESIVANCE was conjunctival redness. Other adverse events reported in patients receiving BESIVANCE occurring in approximately 1-2 percent of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.
• BESIVANCE is not intended to be administered systemically. Quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose. Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.
• Safety and effectiveness in infants below one year of age have not been established.

Please see BESIVANCE full prescribing information here(214.8 KB, PDF).
 
About TRULIGN Toric
The TRULIGN™ Toric posterior chamber intraocular lens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.

About Bausch + Lomb:
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. We develop, manufacture and market one of the most comprehensive product portfolios in our industry with products available in more than 100 countries.

®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
AREDS2 is a registered trademark of the United States Department of Health and Human Services (HHS).
All other product/brand names are trademarks of their respective owners.
© 2014 Bausch & Lomb Incorporated.


News Media Contacts
Kristy Guerra
PR Product Manager, Bausch + Lomb
(585) 338-8095 or [email protected]

Tad Heitmann
BioComm Network on behalf of Bausch + Lomb
(714) 273-2937 or [email protected]

US/LGX/14/0023