Bausch + Lomb Announces Expanded Power Range for TRULIGN™ Toric IOL and Features Other Pharmaceutical, OTC Products and Surgical Platforms During the Annual Meeting of the American Academy of Ophthalmology in Chicago

Bausch + Lomb

TRULIGN Intraocular Power Range Now Available from 10.0 to 25.0 Diopters

OCTOBER 15, 2014, BRIDGEWATER, NJ — Bausch + Lomb, a leading global eye health company, announced today the TRULIGN™ Toric intraocular lens (IOL) is now available in an expanded power range and that it will present several other product innovations in pharmaceuticals, OTC offerings, intraocular lenses and surgical devices and equipment during the Annual Meeting of the American Academy of Ophthalmology (AAO) in Chicago (Oct. 18-21). Two scientific symposia will be sponsored and academy attendees will also have the opportunity to listen to lively discussions on topics including product innovation and nutritionals in the Bausch + Lomb booth (#3126).

Since its approval by the FDA in May 2013, TRULIGN has been available in mid-range powers between 17.0 and 25.0. The expansion now includes 10.0 to 16.5 (in half diopter steps) making the TRULIGN Toric available to cataract patients throughout the most popular power range.

“The ability of the TRULIGN Toric intraocular lens to reduce or eliminate preoperative astigmatism is tremendous,” said Robert Weinstock, M.D. “My patients are enjoying a reduced dependency on glasses for many activities with their TRULIGN implant following cataract surgery and it is helping to significantly enhance their quality of life. I’m pleased to have this IOL in an expanded range so I can provide even more of my patients with this impressive technology.”

The TRULIGN Toric intraocular lens is the first and only toric IOL in the U.S. 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.

Additional powers, from 25.5 to 33.0, are expected later this fall. More information about the TRULIGN Toric IOL is available at www.trulign.com.

New Surgical Product Updates and Announcements

Earlier this summer, the VICTUS^® femtosecond laser received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for laser-assisted lens fragmentation* during cataract surgery. The fragmentation procedure, which follows a capsulotomy, uses the femtosecond laser to split the cataractous lens into sections. This is followed by phacoemulsification for cataract removal.  The VICTUS platform offers a number of different lens fragmentation patterns depending on the cataract grade and user preference.

In February, Bausch + Lomb received 510(k) clearance from the FDA for the creation of cuts/incisions in the cornea of patients undergoing cataract surgery or other ophthalmic treatment requiring cuts/incisions in the cornea. Corneal incisions can now be made in a wide variety of diameters, depths, angles and planes. With the new indication, virtually blade-free cataract surgery is now possible using the VICTUS Platform.  Surgeons will describe their experience with the VICTUS platform during the evening symposia at the Hyatt Regency McCormick on Sat. Oct. 18 (see below for more information).

he BLIS™ Bausch + Lomb Injector System was designed exclusively for use with the enVista^® hydrophobic acrylic intraocular lens (IOL). Introduced in February 2012, enVista is a glistening-free IOL. BLIS, complete with a reusable hand piece and single-use cartridge, allows surgeons safe, controlled delivery of the enVista through unenlarged phaco incisions as small as 2.2 mm.

As announced in March, the Stellaris^® PC Vision Enhancement System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in March for the integrated 532nm laser and software. With this new capability, the Stellaris PC now provides one of the most complete ophthalmic surgical systems for posterior segment, anterior segment and combined procedures. The system will be featured in the cataract section of Bausch + Lomb’s booth.

In early October, Bausch + Lomb introduced the ZeroPhaco™ I/A handpiece, a first-of-its-kind device specifically designed for femtocataract surgery. The disposable I/A handpiece with either 15° or 30° bevel needle is designed for the removal of soft cataracts following femtosecond laser fragmentation without the use of ultrasonic energy. Femtosecond laser-assisted cataract surgery has been shown to produce less corneal swelling in the early postoperative period and potentially less trauma to the corneal endothelium than standard phacoemusification.¹

Visit Bausch + Lomb’s booth (#3126) to participate in live demonstrations of the VICTUS femtosecond laser platform and Stellaris^® and Stellaris^® PC Vision Enhancement Systems. You can also purchase the BLIS and ZeroPhaco I/A handpieces in the booth during the meeting.

New Surgical License Agreements and Acquisitions

In September, Bausch + Lomb announced Valeant Pharmaceuticals, Inc., and Croma reached an agreement under which Valeant will distribute Croma’s ophthalmology and orthopedics products in Western Europe. Through the transaction, Valeant acquired hundreds of distinct medical products including viscoelastics, IOLs, surgical instruments, dry eye and anti-inflammatory pharmaceuticals. This agreement will also provide an opportunity for Bausch + Lomb to introduce a range of complementary products in the United States market that expand the company’s ophthalmic portfolio. Since the acquired products are not yet approved in the United States, Bausch + Lomb will be evaluating and seeking approvals based on that assessment.

As announced in April, Bausch + Lomb has entered into an exclusive license agreement for a three-dimensional surgical navigation technology, the Cirle Surgical Navigation System, from Cirle, Inc., a medical technology incubator based in Miami, Fla. Bausch + Lomb will license the system from Cirle to pursue commercialization for cataract surgery. The Surgical Navigation System is not commercially available in the U.S. at this time, though a prototype will be on display in the Bausch + Lomb booth.

Other Bausch + Lomb Product Updates

Bausch + Lomb is pleased to support the National Eye Institute (NEI) by donating PreserVision^® AREDS 2 Formula eye vitamin and mineral supplement for participants in the NEI’s five-year AREDS2 Age-Related Eye Disease Study 2 follow-up study. Launched in August 2013, PreserVision AREDS 2 formula is the only commercially-available supplement in the United States that exactly matches the NEI-recommended updated formula based on the AREDS2 study. The daily dose (two soft gels) of PreserVision AREDS 2 Formula provides the exact same levels of all six clinically proven nutrients as recommended by the NEI: zinc (zinc oxide 80mg), vitamin C (500mg), vitamin E (400 IU), lutein (10mg), zeaxanthin (2mg), and copper (2mg cupric oxide). The combination of these nutrients at the specific levels recommended by the NEI is patented and only available from Bausch + Lomb. The formula will be featured at the booth.

Soothe^® Xtra Protection (XP) eye drops with Restoryl^® mineral oils will also be highlighted at the Bausch + Lomb booth. The eye drops, which contain a unique emulsion system featuring a proprietary blend of mineral oils and interfacial molecules, were made available as announced by the company in June. Soothe XP targets the main source of dry eye symptoms by helping to replenish the lipid layer of the tear film. A compromised lipid layer of the tear film, which results in tear evaporation, is the deficiency most commonly associated with dry eye symptoms.^2-5 The product on shelf is now preserved with polyquaternium-1 (PQ1) and has a borate buffer system - both are widely used in in ophthalmic formulations.

The company’s pharmaceutical products will also be highlighted in the Bausch + Lomb booth throughout the meeting. The proprietary products will 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%.

Scientific Symposia

Bausch + Lomb is sponsoring two scientific symposia, which will include the following:

1. “Femtosecond Laser HD Video Symposium,” on Saturday, Oct.18 at the W City Center (172 W. Adams Street). The symposia will begin at 5:30 p.m. and will feature the following experts who will present the latest laser technology advancements through streaming HD video: moderator, Terrence P. O’Brien, M.D., and faculty, Jeffrey Whitman, M.D.; Mitchell Shultz, M.D.; I. Paul Singh, M.D.; Michael Endl, M.D.; and Y. Ralph Chu, M.D.
2. “Integration of Advanced Cataract Solutions – a Video Symposium,” on Sunday, Oct.19 in the Regency Ballroom A&B at the Hyatt Regency McCormick Place (2233 S. Dr. Martin Luther King Jr. Drive, Chicago, IL). The video symposium will include Richard Lindstrom, M.D., who will moderate the session and Johnny Gayton, M.D.; Douglas Katsev, M.D.; Anil Shivaram, M.D.; and Robert Weinstock, M.D. Breakfast and registration will begin at 6 a.m. followed by the educational program running from 6:30-7:30 a.m.

Leading Experts Host Bausch + Lomb Booth Talks

The following leading clinical experts will host a series of presentations and discussions in Bausch + Lomb’s booth:

Saturday, Oct. 18:

1. “The First and Only Toric IOL in the U.S. that Delivers More,” by Ehsan Sadri, M.D., at 10 a.m. CST
2. “Nutritionals in AMD: An Update,” by Michael Cooney, M.D., at 11 a.m. CST
3. “Using Technology to Enhance Quality of Vision in Cataract Surgery,” by Paul Singh, M.D., at 1 p.m. CST
4. “enVista IOL: My Clinical Experience,” by Audrey Talley-Rostov, M.D., at 2 p.m. CST 
5. “How to Fit the TRULIGN Toric into Your Practice,” by Dwayne Logan, M.D., at 3 p.m. CST 

Sunday, Oct. 19:

1. “Femto Success in the High Volume Setting,” by Michael Collins, M.D., at 10 a.m. CST
2. “Introducing the TRULIGN Toric IOL: Advanced Technology,” by P. Dee G. Stephenson, M.D., at 11 a.m. CST
3. “Managing Chamber Stability During Femto Cataract Surgery,” by Anil M. Shivaram, M.D., at 1 p.m. CST
4. “Understanding and Managing Persistent Activity in Wet AMD,” by Scott Cousins, M.D., at 2 p.m. CST 
5. “Can Femtosecond Laser Improve Your Productivity?,” by Pavel Stoldulka, M.D., at 3 p.m. CST 

Monday, Oct. 20:

1. “Implementing the ZeroPhaco IA Handpiece and Stellaris System in Femto Cataract Surgery,” by P. Dee G. Stephenson, M.D., at 11 a.m. CST
2. “Complicated Cases and Femtosecond Laser,” by Baseer Khan, M.D., at 1:00 pm. CST

The talks begin on Saturday, Oct. 18 and continue through Monday, Oct. 20. The full schedule is available at the Bausch + Lomb booth.

Scientific Podium Presentations and Posters

Several of Bausch + Lomb’s products will be highlighted during the podium and poster presentations during the meeting, which will include:

1. Castro Matos, R.J. “Clinical Results and Rotation Stability of Toric IOLs.” [AAO Poster PO220: Hall A (Hyatt McCormick Place), Sunday, Oct. 19, 12:30 to 2 p.m. CST]
2. Stodulka, P. “Laser Arcuate Incisions: One Year Safety and Effectiveness Data.” [AAO Poster PA026: E350 (Hyatt McCormick Place), Sunday, Oct. 19, 3:52 to 3:59 p.m. CST]
3. Auffarth, G. “Comparison of Femtosecond Laser Cataract Surgery with the Manual Procedure in a Contralateral Comparative Study.” [AAO Poster PO307: Hall A (Hyatt McCormick Place), Monday, Oct. 20, 12:30 to 2 p.m. CST]

Supporting Eye Health – A Run for Vision

The 29th annual Run for Vision, a 5k benefit run/walk, will begin and finish at Grant Park at Upper Hutchinson Field (the southwest corner of Columbus and Balbo Drives) on Sunday, Oct. 19 at 6:30 a.m. CST. The event is proudly supported by Bausch + Lomb to help raise awareness and support of eye tissue donation on behalf of the Eye Bank Association of America (EBAA).

Pre-registered runners and walkers can pick up their race packets, including new technologically enhanced bib numbers that will communicate participant’s positions throughout the race, at the Bausch + Lomb Booth between 9 a.m. and 5 p.m. CST on Saturday, Oct. 18. AAO attendees can sign up for the race in the Bausch + Lomb booth (#3126) or online at here.

References

1. Takács AI, Kovács I, Miháltz K, Filkorn T, Knorz MC, Nagy ZZ. Central corneal volume and endothelial cell count following femtosecond laser–assisted refractive cataract surgery compared to conventional phacoemulsification. J Refract Surg. 2012;28(6):387-391.
2. Foulks, GN. The correlation between the tear film lipid layer and dry eye disease. Surv Ophthalmol.2007;52(4):369:374.
3. Blackie CA et al. The Relationship Between Dry Eye Symptoms and Lipid Layer Thickness. Cornea 2009;28:789–794.
4. Albietz JM. Prevalence of dry eye subtypes in clinical optometry practice. Optom Vis Sci. 2000;77:357-63.
5. Lemp MA et al. Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Patient Cohort: A Retrospective Study. Cornea. 2012;31:472–478.

*The VICTUS Femtosecond Laser Platform is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; for anterior capsulotomy during cataract surgery; and for the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts/incisions in the cornea and for laser assisted fragmentation during cataract surgery for nuclear cataracts, not for fragmentation of posterior subcapsular and cortical cataracts.