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Shift to Sub-2 mm Microincision Cataract Surgery

Designed to Speed Vision Recovery

Bausch & Lomb's Cataract and Refractive Eye Surgery, Ophthalmic Pharmaceutical Advancements Highlighted at AAO 2007, the World's Largest Gathering of Ophthalmologists

NEW ORLEANS - As thousands of the world's leading ophthalmologists gather in New Orleans for the annual meeting of the American Academy of Ophthalmology (AAO), there's buzz about a radical shift to smaller incision cataract surgery that has the potential to provide faster patient recovery times and a speedier return to more youthful vision.

Bausch & Lomb's new Stellaris(tm) Vision Enhancement System is coupled with an array of specialized sub-2 mm instruments - and outside of the United States, a microincision artificial intraocular lens - to allow surgeons to perform cataract surgery using smaller surgical incisions that can enhance patient comfort and recovery. The system moves today's standard cataract incision size from 2.8 mm, past competitive system capabilities of 2.2 mm, to a 35% smaller, truly microscopic 1.8 mm incision - just 1/10th the width of a dime.

The Stellaris system represents the cornerstone of the company's ground-breaking microincision cataract surgery (MICS(tm)) platform. Ophthalmologists around the world are now adopting advanced MICS techniques to remove the eye's natural lens frequently clouded by the aging process, which results in blurry or hazy vision.

Cataracts affect approximately 80 percent of people over age 60. More than 3.4 million cataract procedures are performed annually in the United States, and over 9 million worldwide.

The 1.8 mm incision takes the current use of self-sealing wounds to the next level. It is expected to virtually eliminate surgically induced astigmatism for better post-operative visual acuity, often approaching the clear vision patients had decades earlier.

The Stellaris system includes multiple innovations, such as being able to choose either 1.8 mm biaxial B-MICS (separate incisions for the phacoemulsification handpiece and irrigation fluidics) or 1.8 mm coaxial C-MICS (a single incision for a combined phaco and fluidics handpiece) procedures. Using the proprietary Stellaris EQ(tm) equalizing fluidics modules, ophthalmologists can choose between flow with optional vacuum capabilities or straight vacuum. Both EQ fluidics modules balance flow and aspiration dynamics for exceptional ocular chamber stability and safety.

Leaping out of consumer electronics and into the operating room, the Stellaris system includes a high-definition touch-screen display and a Bluetooth wireless foot pedal to control key surgical parameters, improving surgical efficiency and potentially reducing overall surgery time.

"I did my first 1.8 mm coaxial C-MICS cataract surgery approximately a year ago with the Stellaris system and found it very simple to make the switch from standard 2.8 mm phaco to the new technique. Since that time I have performed more than 200 C-MICS surgeries and find it as safe and efficient as my standard 2.8 mm cases. In fact, to date I have not had a single complication and most of my patients are back to normal activities with great vision within hours," said Dr. Terry Devine, Guthrie Clinic, Sayre, Penn.

"In Europe, an increasing number of surgeons prefer the biaxial or B-MICS approach, which is what I have used with the Stellaris system. I was particularly impressed with overall chamber stability and ability to optimize power for any level of cataract. The impact on my patients was more positive because they were able to go back to their daily routines faster than with the standard surgical approach," noted H. Burkhard Dick, M.D., Universitäts-Augenklinik, Center for Vision Science at Germany's Ruhr University. "Faster recovery was a critical driver when surgeons moved from 3.2 mm incisions to 2.8 mm. Moving to sub-2 mm is an even greater leap in the right direction."

In addition to the Stellaris system, Bausch & Lomb is showcasing its advancements in refractive surgery and ophthalmic pharmaceuticals during the AAO 2007 conference and exhibition, including:

· Zyoptix® ACE(tm) Advanced Control Eyetracking technology. Zyoptix ACE takes the accuracy and predictability of refractive surgery (LASIK) to new levels by dynamically compensating for intraoperative cyclotorsion (eye rotation), constantly adjusting the laser position in relation to involuntary eye movement by patients. The Zyoptix ACE has recently been released in select markets outside the U.S. It is currently under review by the FDA and is not commercially available in the U.S.

· Zyoptix XP Epi Separator. This forthcoming epithelial separation technology adds to the Zyoptix XP microkeratome platform. It allows surgeons to easily and efficiently switch microkeratome heads to make precise and predictable epithelial flaps in the same time as LASIK flaps.

· Loteprednol etabonate-based prescription pharmaceuticals. Lotemax® (loteprednol etabonate ophthalmic suspension 0.5%) targets ocular inflammation associated with dry eye via a unique, site-active mechanism of action; Zylet® (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) combines the proven anti-inflammatory power of loteprednol etabonate with the broad-spectrum anti-infective agent, tobramycin; and Alrex® (loteprednol etabonate ophthalmic suspension 0.2%) is the only corticosteroid specifically indicated for temporary relief of the signs and symptons of seasonal allergic conjunctivitis, and is the only product that addresses the entire allergic cascade.

The Bausch & Lomb exhibit will run from Saturday, November 10, through Tuesday, November 13, at the New Orleans Convention Center.

As with other ophthalmic corticosteroids, Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva and in mycobacterial and fungal diseases of the eye. Prolonged use may result in secondary glaucoma, cataract formation, and secondary ocular infections following suppression of the host response and/or perforation of the globe. The most common adverse events in patients treated with Lotemax were abnormal vision/blurring, burning, chemosis, discharge, and dry eyes.

As with other steroid/anti-infective ophthalmic combination drugs, Zylet is contraindicated in most viral diseases of the cornea and conjunctiva and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prolonged use of corticosteroids may result in glaucoma, as well as increase the hazard of secondary ocular infections. The incidence of adverse events reported by subjects treated with Zylet included injection (approximately 20%) and superficial punctate keratitis (approximately 15%).

As with other ophthalmic corticosteroids, Alrex is contraindicated in most viral diseases of the corneas and conjunctiva and in mycobacterial and fungal diseases of the eye. Prolonged use may result in secondary glaucoma, cataract formation, and secondary ocular infections following suppression of the host response and/or perforation of the globe. The most common adverse events in patients treated with Alrex were abnormal vision/blurring, burning, chemosis, discharge, and dry eyes.

Please refer to full prescribing information for Lotemax, Zylet and Alrex at www.bausch.com

 

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