BRIDGEWATER, NJ — Bausch + Lomb, a leading global eye health company, will showcase several product innovations at the upcoming Annual Meeting of the American Academy of Ophthalmology (AAO) in New Orleans (Nov. 16-19). This includes a comprehensive range of products including prescription pharmaceuticals, OTC offerings, intraocular lenses and other eye surgery products. Academy attendees will also be invited to attend scientific symposia and a series of thought-provoking discussions in the Bausch + Lomb booth (#2325).
Hands-on demonstrations of the VICTUS® Femtosecond Laser platform, the first femtosecond laser capable of supporting cataract and corneal flap procedures on a single platform, will also be available. The demonstrations will be given every 30 minutes, Nov. 16-18 from 9 a.m. to 5 p.m. CST and Nov. 19 from 9 a.m. to 1 p.m. CST in the Bausch + Lomb booth (#2325).
Product Innovations and Updates
Earlier this year, Bausch + Lomb debuted two products to its comprehensive line of pharmaceutical solutions: PROLENSA® (bromfenac ophthalmic solution) 0.07 percent and LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5 percent.
PROLENSA (available in 1.6ml and 3ml bottle sizes) is a nonsteroidal anti-inflammatory ophthalmic solution 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 potency of the bromfenac molecule and effective ocular penetration.
LOTEMAX® Gel is a topical corticosteroid formulation 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. Both PROLENSA® and LOTEMAX® will be highlighted at the Bausch + Lomb booth during AAO.
As introduced in August, rounding out the company’s ocular nutrition offerings, PreserVision® AREDS 2 Formula eye vitamin and mineral supplement is the first and only commercially-available supplement in the United States that exactly matches the updated formula from the National Eye Institute (NEI) Age-Related Eye Disease Study 2 (AREDS2). The daily dose (two soft gels) of new PreserVision® AREDS 2 Formula provides the exact same levels of all six clinically proven nutrients as the NEI supported formula: vitamin C (500mg), vitamin E (400 IU), lutein (10mg)/zeaxanthin (2mg), zinc (80mg zinc oxide), and copper (2mg cupric oxide). The combination of these nutrients at the specific levels recommend by the NEI is only available from Bausch + Lomb and will also be featured at the booth.
Adding to the company’s surgical solutions, the U.S. Food and Drug Administration (FDA) granted approval for the TRULIGN™ Toric posterior chamber intraocular lens (IOL) earlier this spring. The TRULIGN™ Toric intraocular lens is the first and only toric IOL that corrects for astigmatism and has the additional capacity to deliver improved vision across a natural range of focus. The 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. The TRULIGN™ Toric will be featured in the Bausch + Lomb booth as well as during an evening symposium at the W New Orleans on Saturday, Nov. 16 (see below).
Introduced in June, the TRULIGN™ Toric Instrument Set will also be on display at AAO. This instrument set is one of most recent additions to the Bausch + Lomb Storz® ophthalmic instrument portfolio for cataract, vitreoretinal and refractive surgical procedures. Other new instruments to be featured at AAO include the Osher Cantilever Lid Speculum, Wortz Femto Dissection Cannula, and a new series of Capsule Polishers designed for advanced cataract techniques. Over 20 new instruments for 2013 will be on display and available for purchase at the Bausch + Lomb booth (#2325).
Scientific Symposia
Bausch + Lomb is sponsoring three scientific symposia:
1) “Selecting an NSAID for Cataract Surgery: What Really Matters,” on Saturday, Nov. 16 from 7 to 8 a.m. CST in the Louisiana Ballroom at the Loews New Orleans Hotel including Terry Kim, MD; John Hovanesian, MD; and Bonnie Henderson, MD
2) “Introducing New IOL Technology to Maximize Patient Outcomes: TRULIGN™ Toric and enVista® IOLs,” on Saturday, Nov. 16 from 6:15 to 7:15 p.m. CST at the W Hotel New Orleans featuring moderator: Mark Packer, MD; and faculty: James Khodabakhsh, MD; Kurt Weir, MD; and Jeffrey Whitman, MD
3) “Advanced Laser Technology Video Symposium: Cataract and Refractive Surgical Techniques,” on Sunday, Nov. 17 from 6 to 8 p.m. CST at the Westin Canal Place including moderator Steven J. Dell, MD; and faculty: Y. Ralph Chu, MD; Sheraz Daya, MD; Pavel Stodulka, MD; Robert J. Weinstock, MD; and Jeffrey A. Whitman, MD
Booth Talks
Bausch + Lomb will host a series of presentations/discussions in its booth. These talks will be given by leading clinical experts including the following:
Saturday, Nov. 16:
1) “Evaluation of the Stellaris® DigiFlow System to Manage Fluid Flow During Surgery,” by R. Bruce Wallace, MD, at 10 a.m. CST
2) “How TRULIGN Can Fit into your Practice,” by Doug Katsev, MD, at 11 a.m. CST
3) “AREDS2: Perspectives and Implications,” By Michael J. Cooney, MD, at 1 p.m. CST
4) “Selecting an NSAID for Cataract Surgery: What Really Matters,” by Sheri Rowen, MD, at 2 p.m. CST
5) “LOTEMAX Gel: What’s In It For You and Your Patients?,” by Rajesh Rajpal, MD, at 2:30 p.m. CST
6) “Advanced Femtophaco Surgical Techniques,” by Y Ralph Chu, MD, at 3 p.m. CST
Sunday, Nov. 17:
1) “enVista™: Clinical Experience in 125 Eyes,” by P Dee G Stephenson, MD, at 10 a.m. CST
2) “TRULIGN Toric: A New Direction in Astigmatism Correction ,” by Jay Pepose, MD, Ph.D at 11 a.m. CST
3) “Selecting an NSAID for Cataract Surgery: What Really Matters,” by Mitchell Jackson, MD, at 11:30 a.m. CST
4) “LOTEMAX Gel: What’s In It For You And Your Patients?,” by Steven Lane, MD, at 2:30 p.m. CST
5) “Femtosecond Laser: The Canadian Experience,” by Baseer Khan, MD, at 3 p.m. CST
Monday, Nov. 18:
1) “TRULIGN: The Only IOL that Delivers More,” by P Dee G Stephenson, MD, at 10 a.m. CST
2) “Advanced Femtophaco Surgical Techniques,” by Robert Weinstock, MD, at 11 a.m. CST
3) “How to Become a Bausch + Lomb Clinical Investigator,” by Jon Williams, Ph.D., at noon CST
The talks begin on Saturday, Nov. 16 and continue through Monday, Nov. 18. The full schedule is available at the Bausch + Lomb booth.
Scientific Podium Presentations and Posters
There will be nine podium presentations and posters featuring Bausch + Lomb products, which will be highlighted during the schedule as follows:
Main Session:
1) Pepose JS. “A Prospective, Randomized, Multicentered Clinical Trial of the TRULIGN™ Toric Presbyopia-Correcting IOL.” [AAO Poster PO280: Hall C (Morial Convention Center), Monday, Nov. 18, 12:30 to 2:30 p.m. CST]
2) Packer M. “Properties of the Lens Material in a New, 1-Piece, Foldable, Hydrophobic Acrylic IOL.” [AAO Poster PO014: Hall C (Morial Convention Center), Sunday, Nov. 17, 12:30 to 2 p.m. CST]
3) Packer M. “Safety and Visual Outcomes in Cataract Patients Implanted with a Glistening-Free Hydrophobic Acrylic IOL.” [AAO Poster PO015: Hall C (Morial Convention Center), Sunday, Nov. 17, 12:30 to 2 p.m. CST]
4) Endl M. “Precision of Corneal Flaps Created with a New Femtosecond Laser.” [AAO Poster PO424: Hall C (Morial Convention Center), Monday, Nov. 18, 12:30 to 2 p.m. CST]
5) Holzer MP. “Single-center, Contralateral Evaluation of Femtosecond Laser Cataract Surgery Compared With Manual Cataract Surgery.” [AAO Poster PO010: Hall C (Morial Convention Center), Sunday, Nov. 17, 12:30 to 2 p.m. CST]
ISRS Subspecialty Day:
1) Ang RT. “Postoperative Year 1 Results of a Prospective, Randomized Study Comparing 1 Accommodating and 2 Multifocal IOLs.” [Refractive Surgery Paper Session III: Room: La Nouvelle Orleans C (Morial Convention Center), Friday, Nov. 15, 3:15 to 4:24 p.m. CST]
2) Pepose JS. “Safety and Efficacy of TRULIGN™ Toric Presbyopia-Correcting IOL.” [Refractive Surgery e-Poster RP30037027: Room: La Nouvelle Orleans AB (Morial Convention Center), Friday, Nov. 15, 7 a.m. to Saturday, Nov.16, 5:30 p.m. CST]
3) Packer M. “Safety and Visual Outcomes with a 1-Piece Hydrophobic Acrylic IOL in Cataract Patients.” [Refractive Surgery e-Poster RP30037138: Room: La Nouvelle Orleans AB (Morial Convention Center), Friday, Nov. 15, 7 a.m. to Saturday, Nov. 16, 5:30 p.m. CST]
4) Whitman J. “Evaluation of Corneal Flaps Created with 2 Femtosecond Laser Platforms.” [Refractive Surgery e-Poster RP30037140. Room: La Nouvelle Orleans AB (Morial Convention Center), Friday, Nov. 15, 7 a.m. to Saturday, Nov. 16, 5:30 p.m. CST]
Run for Vision to Support Eye Health
In conjunction with the Annual American Academy of Ophthalmology (AAO) meeting, Bausch + Lomb is proudly supporting the Run for Vision, a 5K benefit run/walk. Since its inception, this event has raised more than a quarter of a million dollars for the Eye Bank Association of America, the nation’s oldest national transplant association and helped raise awareness about the importance of tissue donation. This 28th Annual run/walk will be held at the New Orleans RiverWalk at Canal Street and Convention Center Drive on Sunday, Nov. 17 at 6:30 a.m. CST. AAO attendees can register online at http://www.restoresight.org/upcoming-events/runforvision/ or at the Bausch + Lomb booth (#2325).
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 suggests 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).
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 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.
® /™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2013 Bausch & Lomb Incorporated.
AREDS2 is a registered trademark of the United States Department of Health and Human Services (HHS).
News Media Contacts
Kristy Guerra
U.S. Product Communicatons, Bausch + Lomb
+1 (585) 338-8095 or +1 (585)-746-7206
kristy.guerra@bausch.com
Tad Heitmann
BioComm Network on behalf of Bausch + Lomb
(714) 273-2937
theitmann@BioCommNetwork.com
US/PRA/13/0192
SUR/SRG/13/097
United States
