US debut for recently approved VICTUS™ Femtosecond Laser Platform and enVista®
hydrophobic acrylic intraocular lens (IOL) with the Bausch + Lomb® IOL Injector (INJ100)
LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5%
in a gel drop formulation slated for launch January 2013
ROCHESTER, NY — Bausch + Lomb, the global eye health company, will launch several innovative products at the upcoming Annual Meeting of the American Academy of Ophthalmology (Chicago, November 10-13), which will provide ocular surgeons with compelling new treatment options for customizing patient care and potentially improving outcomes. The company will be providing hands-on demonstrations of the newly approved VICTUS™ Femtosecond Laser platform and enVista® hydrophobic acrylic intraocular lens, and showcasing its broad range of surgical, pharmaceutical and consumer vision solutions in its booth (#3126). In addition, there will be research presented at the conference related to several new products, along with a series of thought-provoking talks in the Bausch + Lomb booth, led by industry luminaries and company executives.
New Launches: VICTUS™ Femtosecond Laser Platform & enVista® Intraocular Lens
Earlier this summer, the U.S. Food and Drug Administration (FDA) granted 510(k)-clearance for the VICTUS femtosecond laser platform to Bausch + Lomb and partner, Technolas™ Perfect Vision GmbH (TPV), a leading ophthalmology laser company. The VICTUS femtosecond laser is capable of supporting cataract and corneal (LASIK flap) procedures on a single platform. The versatile system is designed to provide greater precision compared to manual cataract surgery techniques, potentially enhancing patient experience. Together, Bausch + Lomb and TPV have been promoting the system globally and will be performing demonstrations in their booths during the meeting (#3126 & 4226). In addition, Bausch + Lomb is sponsoring a breakfast symposium at the Hyatt Regency McCormick Place on Sunday, Nov. 11 at 6:30 a.m. CST entitled, New Femtocataract and IOL Technology for the Refractive Cataract Surgeon, followed that evening by a TPV-sponsored international alliance program at The James Chicago on Sunday, Nov. 11 at 6:30 p.m. CST entitled, New Frontiers in Femtosecond Cataract, Refractive and Presbyoptic Technology.
Bausch + Lomb also received FDA approval in May for the enVista® hydrophobic acrylic intraocular lens (IOL), which represents a significant step forward in IOL technology, as it is the first and only IOL approved in the U.S. with labeling that states: “No glistenings of any grade were reported for any subject at any visit in the clinical study”.1-2 The enVista lens is Bausch + Lomb’s first entry into the hydrophobic acrylic market, using a unique combination of aspheric, aberration-free Advanced Optics (AO) technology.3 Additionally, the enVista lens is designed to minimize Posterior Capsular Opacification (PCO), a common post-surgical complication with IOLs that causes vision to become clouded post-surgery. The new Bausch + Lomb IOL Injector (INJ100) was also recently FDA cleared. Surgeons will describe their experiences with theenVista lens at the breakfast symposium at the Hyatt Regency McCormick Place on Sunday, Nov. 11 at 6:30 a.m. CST entitled, New Femtocataract and IOL Technology for the Refractive Cataract Surgeon.
Upcoming Launch: LOTEMAX® GEL
Approved by the FDA in late September 2012 and launching in the next few months is LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5% in a gel drop formulation, a new topical corticosteroid in Bausch + Lomb’s line of loteprednol ophthalmic products. LOTEMAX GEL is a unique corticosteroid gel drop formulation designed to adhere to the ocular surface and provide dose uniformity. It is indicated to treat post-operative inflammation and pain following ocular surgery.
Recent Product Additions and Updates
The latest additions to the Bausch + Lomb Storz™ industry-leading ophthalmic instrument portfolio for vitreoretinal and refractive surgical procedures will be on display at AAO, including a range of specialized packs and instruments for femtosecond laser, vitreoretinal and refractive surgical procedures. Rounding out the company’s broad portfolio are the Daya Trans Lens Hydrodissection and Hu Femto Hydrodissection Cannulas, Storz Single Use ILM Forceps andStableGrip™ Slimline handle and tip series, along with the MacRae Lasik Flap Management and Mini-PRK Instrumentation set. Also featured are a new series of multi-function instruments including the Parekh Visco Chopper and the Grayson Dual Ended Lens Chopper/Manipulator. The instruments will be on display and available for purchase at the Bausch + Lomb booth (# 3126).
In September of 2012, Besivance® (besifloxacin ophthalmic suspension) 0.6% eye drop received approval from the FDA for four additional pathogens within its label, including an indication to treat bacterial conjunctivitis infections caused by susceptible isolates of Pseudomonas aeruginosa*, a rare but potentially virulent pathogen that can be associated with serious eye conditions, such as corneal ulcers and blindness. More detail on the new pathogen indications will be provided in the Bausch + Lomb booth (# 3126).
Cleared by the FDA in June 2012, Biotrue® ONEday contact lenses are a bio-inspired daily disposable lens made fromHyperGel™, an innovative, next generation of daily disposable material that has the best features of conventional hydrogels and silicone hydrogels. The lens offers high water content and delivers more oxygen than a traditional hydrogel – all without the need for silicone – while maintaining the comfort of conventional hydrogels. Biotrue ONEday works like the eyes, to provide comfortable vision throughout the day. At the booth (#3126), attendees can learn more about this bio-inspired lens and find out what patients are saying about Biotrue ONEday.
Booth Talks
Bausch + Lomb will host a series of presentations/discussions in its booth regarding the future of ophthalmology, product innovation, and practice management. These talks will be led by a host of industry luminaries including Richard L. Lindstrom, M.D., Minnesota Eye Consultants; Steven Dell, M.D., Dell Laser Consultants; Robert J Weinstock, M.D., Eye Institute of West Florida and The Weinstock Laser Eye Center; and James Khodabashk, M.D., Beverly Hills Vision Institute, Inc., as well as members of Bausch + Lomb’s executive, clinical and medical affairs team including the company’s chief medical officer, Cal Roberts, M.D. The talks begin on Saturday, Nov. 10 and continue through Monday, Nov. 12. A full schedule is available at the Bausch + Lomb booth.
Paper and Poster Presentations
Friday:
Stodulka P, “First 1,000 cases of laser-assisted cataract surgery experience.” ISRS Subspecialty Day presentation [Free Paper Session II, Grand Ballroom S100AB, Friday, Nov. 9, 2:14 p.m. CST]
Sunday:
Ang R. "Randomized clinical comparison study of 3 IOLs: Crystalens AO, ReSTOR +3, and Tecnis multifocals." [Poster PO023. Hall A. Sunday, Nov. 11, 12:30 p.m. - 2 p.m. CST]
Gow JA, et al. "Integrated phase 3 clinical trials of low-concentration, modified bromfenac ophthalmic solution dosed once daily for cataract surgery." [Poster PO005. Hall A. Sunday, Nov. 11, 12:30 p.m.- 2 p.m. CST]
Nichamin L, et al. “Rotational Stability of a Glistening-Free One-Piece Hydrophobic Acrylic IOL” [Poster PO026, Hall A, Sunday, Nov. 11, 12:30 p.m. – 2:30 p.m. CST]
Pepose JS, et al. "Comparison of through-focus image sharpness across 5 presbyopia-correcting IOLs." [Poster PO031. Hall A. Sunday, Nov. 11, 12:30 p.m. - 2 p.m. CST]
Rajpal R, et al. “Loteprednol etabonate gel 0.5% in the treatment of ocular inflammation and pain following cataract surgery.” [Poster PO021, Hall A, Sunday, Nov. 11, 12:30 p.m. - 2 p.m. CST]
Monday:
Heiner P, et al. “Early clinical experience of a new hydrophobic intraocular lens” [Poster Session # PO303, Hall A, Monday, Nov. 12, 2 p.m. - 3:30 p.m. CST]
McDonald M, et al. “Multidrug-Resistance in Bacterial Conjunctivitis Studies with Besifloxacin Ophthalmic Suspension, 0.6%.” [Poster PO327, Hall A, Monday. Nov. 12, 2 p.m. - 3:30 p.m. CST]
Qazi MA, et al. "Optical Quality Analysis System visual quality after implantation of presbyopic IOLs." [Poster PO311. Hall A. Monday, Nov. 12, 2 p.m. - 3:30 p.m. CST]
Tuesday:
Chu R, et al. "NEI-RQL-42 and SVI quality of life and vision metrics after bilateral implantation of 3 presbyopia-correcting IOLs." [Paper PA081. Room S406B. Tuesday, Nov. 13, 9:30 a.m. - 9:37 a.m. CST]
Initiatives in Support of Eye Health
Bausch + Lomb will be supporting the Are You a Donor? project, an initiative by SightLife, the only non-profit global health organization solely focused on eliminating corneal blindness in the U.S. and around the world. The Are You a Donor?project will encourage physicians and other AAO attendees to register on site as eye, organ and tissue donors.
In addition, for nearly three decades, during AAO, Bausch + Lomb has supported the Run for Vision, a 5K benefit run/walk. This event has raised more than a quarter of a million dollars in support for the Eye Bank Association of America, the nation’s oldest national transplant association. This year the run/walk will be held in downtown Chicago on Sunday, Nov. 11 at 6:30 a.m. CST at Grant Park. AAO attendees can register on-line at https://www.signmeup.com/site/reg/register.aspx?fid=9S2VHJ7 or sign up at the Bausch + Lomb booth.
About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs more than 11,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.
REFERENCES
*Efficacy for this organism was studied in fewer than 10 infections.
1. Bausch & Lomb, Inc. Data on file, 2009.
2. Tetz. ASCRS. 2009.
3. Pepose JS, Qazi MA, Edwards KH, Sanderson JP, Sarver EJ. Comparison of contrast sensitivity, depth of field and ocular wavefront aberrations in eyes with an IOL with zero versus positive spherical aberration. Graefes Arch Clin Exp Ophthalmol. 2009; 247(7):965-973. ®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
All other band/product names are trademarks of their respective owners.
© 2012 Bausch & Lomb Incorporated.
# # #
News Media Contacts
Jeanie Herbert
Global Surgical Communications, Bausch + Lomb
(949) 521-7948 (714) 325-3584 (mobile) or jeanie.herbert@bausch.com
Elizabeth Murphy
Global Communications, Bausch + Lomb
(585) 338-8528 or elizabeth.murphy@bausch.com
Tad Heitmann
BioComm Network on behalf of Bausch + Lomb
(714) 273-2937 or theitmann@BioCommNetwork.com
United States
