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Bausch + Lomb Receives FDA Approval of TRULIGN® Toric IOL Calculator Enhancements, Announces Capsular Tension Ring Addition, and Showcases Latest Innovations in its Product Portfolio During the ASCRS Annual Meeting in New Orleans



FOR RELEASE WEDNESDAY, MAY 4, 2016



BRIDGEWATER, NJ – Bausch + Lomb, a leading global eye health company, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for a number of enhancements to its TRULIGN® Toric IOL calculator; will soon offer surgeons a Capsular Tension Ring (CTR) as part of its portfolio; and will feature its latest product advancements and platforms during the upcoming annual American Society of Cataract and Refractive Surgery (ASCRS) symposium in New Orleans, LA (May 6-10).

 

During the ASCRS symposium, Bausch + Lomb will sponsor a scientific symposia focused on cataract surgery and host a variety of interactive discussions with ophthalmic thought leaders in its booth (#327). More than two dozen scientific podium and poster presentations will also feature products from the company’s Surgical portfolio.

 

Enhancing the Product Portfolio
Designed to help further streamline the TRULIGN® Toric IOL fitting process, the FDA approval of the company’s recent enhancements to the TRULIGN® Toric calculator will provide surgeons and technicians a simplified design that is easy-to-use, convenient, and accessible. The calculator enhancements, which were updated based on direct feedback from customers, will include a number of refinements allowing users to:

  • Interface directly with the IOLMaster or Lenstar systems to help facilitate the input of patient data and create a seamless user experience;
  • Display the make and model of the Crystalens® IOL, if a non-toric lens is recommended, while displaying the IOL at 90 degrees with no axis of alignment.

“We are very grateful for the terrific partnerships we have with our customers, which help us receive routine feedback on our products,” said Andy Chang, senior vice president and general manager, U.S. Surgical, Bausch + Lomb. “We are deeply committed to investing in novel advancements as well as in our current product portfolio to ensure it is optimized as needed to best meet the needs of our customers and their patients. The TRULIGN® Toric calculator enhancements are a perfect demonstration of that.”

 

In addition to continuing to enhance its portfolio through product optimizations, Bausch + Lomb is also preparing to launch the new Bausch + Lomb FortifEYE™ capsular tension ring (CTR).

 

“We know that CTRs are an important part of many of our customer’s armamentarium, so we look forward to providing our customers an exceptional CTR offering that has the significant benefits of a posterior chamber IOL and will help further strengthen and diversify the products available in Bausch + Lomb’s Surgical portfolio,” said Chang.

The company expects to receive FDA approval for the use and commercialization of the FortifEYE™ capsular tension ring (CTR) later this year.
 

Product & Platform Innovations Featured in the Bausch + Lomb Booth
Attendees who visit the Bausch + Lomb booth at the ASCRS symposium can attend live demonstrations of the company’s featured surgical platforms, which include the Stellaris® and Stellaris® PC Vision Enhancement systems, and the VICTUS® Femtosecond Laser.

Many of the company’s pharmaceuticals, which include BESIVANCE® (besifloxacin ophthalmic suspension) 0.6%, Lotemax® Gel (loteprednol etabonate ophthalmic gel) 0.5%, Zylet® (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension), ZIRGAN® (ganciclovir ophthalmic gel) 0.15%, BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%, ISTALOL® (timolol maleate ophthalmic solution) 0.5%, Retisert® (fluocinolone acetonide intravitreal implant) 0.59 mg, Lacrisert® (hydroxypropyl cellulose ophthalmic insert), VISUDYNE® (verteporfin for injection), and PROLENSA® (bromfenac ophthalmic solution) 0.07%, will also be featured in the booth.

 

The company’s diagnostic tools, the Sjö® diagnostic test kit, which helps to aid in the early detection of Sjögren’s syndrome, and Doctor’s Allergy Formula™, which enables eye care practitioners to objectively diagnose and identify the root cause of patient’s ocular allergies, will also be available for attendees to learn more about in its booth.

 

Scientific Symposia Focused on Cataract Surgery

Bausch + Lomb is supporting the scientific symposia, “Growing Your Practice Through Long-Term Cataract Outcomes,” led by program chair, John A. Hovanesian, M.D., on Sunday, May 8, at the Marriott Convention Center (Blaine Kern Ballroom). The discussion will include the following faculty members: Deepinder K. Dhaliwal, M.D., L.Ac; Terrence P. O’Brien, M.D.; and Farrell “Toby” Tyson, M.D. FACS.  Registration begins at 11:30 a.m. and the program will commence at Noon CST. Attendees can register at: www.EyeWorld.org/meetings/bausch

 

Interactive Talks with Industry-Leading Ophthalmologists in the Bausch + Lomb Booth
Bausch + Lomb will host a series of interactive programs in its booth led by an impressive and diverse group of highly regarded speakers. The talks begin on Saturday, May 7, and continue through Sunday, May 8.

 

The schedule of speakers and topics include:

 

Saturday, May 7:

  • 10-11 a.m. CST:
    enVista® IOL: Premium Optics on a Monofocal IOL,” by P. Dee Stephenson, M.D.; Quentin Allen, M.D.; and Doug Katsev, M.D.

  • 1-2 p.m. CST:
    Complex Cataracts and Pars Plana Vitrectomy: Advanced Techniques for Anterior Segment Surgeons,” by Yuri McKee, M.D.; and John Kitchens, M.D.

  • 2-3 p.m. CST
    Doctor’s Allergy Formula™ Diagnostic Test: Aiding the Diagnosis of Ocular Surface Disease,” by Marguerite McDonald, M.D.

  • 3-4 p.m. CST:
    VICTUS® Femtosecond Laser: Bringing the ‘Big Easy’ to Cataract Surgery,” by Thomas Elmer, M.D.; Mitchell Shultz, M.D.; and Frank Bowden III, M.D.



Sunday, May 8:

  • 10-11 a.m. CST:
    Achieving 20/Happy with Premium IOLs,” by Sheri Rowen, M.D., Charles ‘Chuck’ Williamson, M.D.; and Blake Williamson, M.D. 

  • 11-Noon CST:
    VICTUS® Femtosecond Laser - A Global Perspective,” by Sheraz Daya. M.D.; Baseer Khan, M.D.; and Robert Ang, M.D.

  • 2-3 p.m. CST:
    The Premium Vision Practice – How Practice Managers Work with Surgeons to Achieve Success,” by Patti Barkey, COE; Carrie Jacobs, COE; and I. Paul Singh, M.D.
     
  • 3-4 p.m. CST:
    Sjögren’s Disease and Diagnosis with the Sjö Diagnostic Test,” by Cynthia Matossian, M.D.


Featured Scientific Podium Presentations and Posters
Bausch + Lomb’s products will be featured in more than 20 podium presentations, e-posters, and films, with several highlighting the VICTUS® Femtosecond laser, enVista® hydrophobic acrylic intraocular lens, TRULIGN® Toric posterior chamber intraocular lens, and the Stellaris® PC Vision Enhancement System.

 

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

 

Saturday:

  • Chu, Ralph. “Lower Enhancement Rates for Accommodating IOL After Femtosecond Laser–Assisted Surgery.” [ASCRS Paper Session: Room 223, Saturday, May 7, 2:22-2:27 p.m. CST].

  • Cornell, Peter. “Retrospective Study of Results of Implantation of a Toric Accommodating IOL.” [ASCRS Paper Session: Room 219, Saturday, May 7, 1:37-1:42 p.m. CST].

  • Hovanesian, John. “Satisfaction and Spectacle Independence with Accommodating IOLs versus Multifocal IOLs 2 Years After Surgery.” [ASCRS Paper Session: Room 218, Saturday, May 7, 2:09-2:14 p.m. CST].

  • Matossian, Cynthia. “Clinical Outcomes for Low-Diopter Accommodating Toric IOL.” [ASCRS Paper Session: Room 217, Saturday, May 7, 3:37-3:42 p.m. CST].

  • Schultz, Mitch. “Evaluation of Enhanced Depth of Focus Using a Single-Piece Advanced Optic Monofocal Hydrophobic Acrylic IOL.” [ASCRS Paper Session: Room 218, Saturday, May 7, 3:27-3:32 p.m. CST].

  • Stephenson, Dee. “Refractive and Visual Acuity Results in Patients with a Toric Accommodating IOL and a Minimum of 1-Year Follow-up.” [ASCRS Paper Session: Room 217, Saturday, May 7, 1:32-1:37 p.m. CST].

Sunday:

  • Sadri, Ehsan. “Clinical Evaluation of New Monofocal IOL.” [ASCRS Paper Session: Room 217, Sunday, May 8, 1:32-1:37 p.m. CST].

  • Singh, I. Paul. “Femtosecond Laser–Assisted Cataract Surgery: Effect on Early Visual Acuity.” [ASCRS Paper Session: Room 219, Sunday, May 8, 8:02-8:07 a.m. CST].

  • Whitman, Jeff. “Femtosecond Laser–Assisted Cataract Surgery: Effect on Visual Acuity and Refractive Accuracy.” [ASCRS Paper Session: Room 224, Sunday, May 8, 9:14-9:19 a.m. CST].

Monday:

  • Ang, Robert. “Prospective Randomized Study Comparing the Visual Outcomes of Accommodating IOL and 2 Multifocal IOLs: 4-Year Follow-up.” [ASCRS Paper Session: Room 219, Monday, May 9, 1:02-1:07 p.m. CST].

  • Depenbusch, Michael. “Laser-Free and Phaco-Free Cataract Surgery Not Requiring Laser or Ultrasound: Prospective Study of 50 Consecutive Cases.” [ASCRS Paper Session: Room 219, Monday, May 9, 8:57-9:02 a.m. CST].

  • Packer, Mark. “Optical Characteristics and Quality of Vision: Objective Comparison of Refractive and Diffractive IOL Types.”  [ASCRS Paper Session: Room 218, Monday, May 9, 2:02-2:07 p.m. CST].

  • Page, Tim. “Cortex Removal Method to Reduce Posterior Capsule Rupture During Manual Nuclear Expression Small-Incision Cataract Surgery.” [ASCRS Paper Session: Room 219, Monday, May 9, 2:13-2:18 p.m. CST].

  • Schultz, Mitch. “Comparative Analysis of Effective Phaco Time and Energy Using Dual Linear Venturi Phacoemulsification in Traditional Versus Femto–Assisted Cataract Surgery. [ASCRS Paper Session: Room 218, Monday, May 9, 3:58-4:03 p.m. CST].

  • Weinstock, Rob. “Retrospective Analysis of Patients with Previous LASIK Having Cataract Surgery with Accommodating IOL Implantation.” [ASCRS Paper Session: Room 219, Monday, May 9, 2:18-2:23 p.m. CST].


Tuesday
:

  • Jackson, Mitch. “Retrospective Comparison of 2 Accommodating IOLs in Post-Refractive Surgery Patients Having Cataract Surgery: Visual Outcomes.” [ASCRS Paper Session: Room 223, Tuesday, May 10, 9:34-9:39 a.m. CST].

  • Liang, Eva. “Evaluation of Pseudophakic Accommodation Using an Optical Quality Analyzer.”  [ASCRS Paper Session: Room 219, Tuesday, May 10, 8:46-8:51 a.m. CST].

  • Page, Tim. “Phacoemulsification Power and Efficiency: Review of Current Needle Motion and Power Modulation Used in Ultrasonic Phacoemulsification.” [ASCRS Paper Session: Room 223, Tuesday, May 10, 10:12-10:17 a.m. CST].

  • Page, Tim. “Post-Occlusion Surge and Phacoemulsification Efficiency: Comparative Review of Phacoemulsification Vacuum Systems.” [ASCRS Paper Session: Room 223, Tuesday, May 10, 11:02-11:07 a.m. CST].


E-poster/Film:

  • Packer, Mark. “Estimating Photic Phenomena and Assessment of Glare.” [ASCRS e-Poster Session: KIOSKS, Friday, May 6 – Monday, May 9, 7 a.m. – 4:30 p.m.; Tuesday, May 10, 7 a.m. – 2:30 p.m. CST].

  • Singh, I. Paul. “Live Swept–Source OCT: Opening the Wound and Anterior Capsule under the Femtosecond Laser.” [ASCRS Film: KIOSKS, Friday, May 6 – Monday, May 9, 7 a.m. – 4:30 p.m.; Tuesday, May 10, 7 a.m. – 2:30 p.m. CST].

  • Stephenson, Dee. “Comparison of Glare and Halo Symptoms with 2 IOL Models.” [ASCRS e-Poster Session: KIOSKS, Comparison of Glare and Halo Symptoms with 2 IOL Models].

  • Whitman, Jeff. “Effect of Femtosecond Laser–Assisted Cataract Surgery on IOL Position.” [ASCRS e-Poster Session: KIOSKS, Effect of Femtosecond Laser–Assisted Cataract Surgery on IOL Position].

 

About the 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 the VICTUS Femtosecond Laser

Bausch + Lomb has been installing VICTUS® platforms in leading surgery centers globally since it received CE mark in November 2011 and the FDA clearances in July 2012. It is now one of the only femtosecond lasers in the U.S. with clearance for the creation of a corneal flap in patients undergoing LASIK surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea and laser-assisted lens fragmentation during cataract surgery. The VICTUS platform has received additional CE marks including corneal incisions, penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.


About the enVista Intraocular Lens

The enVista® intraocular lens is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed.  The lens is intended for placement in the capsular bag.

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 except Zirgan a registered trademark of Laboratoires Théa Corporation and Visudyne a registered trademark of Novartis AG used under license. Any other product/brand names are trademarks of their respective owners. © 2016 Bausch & Lomb Incorporated. CRT.0032.USA.16

 

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News Media Contacts
Kristy Marks
PR Product Manager, Bausch + Lomb
(585) 338-8095 or
kristy.marks@bausch.com

Teresa Panas
BioComm Network, on behalf of Bausch + Lomb
(973) 809-8590 or tpanas@biocommnetwork.com

Michele Gray
BioComm Network, on behalf of Bausch + Lomb
(917) 449-9250 or
michele_gray@me.com

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