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Media Contact:
Don Murphy
Zeno Group, on behalf of Bausch + Lomb
don.murphy@zenogroup.com
(212) 299-8970

BAUSCH + LOMB ANNOUNCES FDA FILING OF EXTENDED WEAR INDICATION FOR 
BAUSCH + LOMB ULTRA® FAMILY OF CONTACT LENSES

 

BRIDGEWATER, New Jersey, Nov. 1, 2017 – Bausch + Lomb, a leading global eye health company, today announced that it has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) to approve Bausch + Lomb ULTRA® contact lenses for extended wear. If approved, Bausch + Lomb® ULTRA contact lenses would be indicated for up to seven days of continuous wear.  

“Bausch + Lomb is committed to providing all those in need of contact lenses with advancements that are innovative, comfortable, and designed to meet their lifestyle,” said John Ferris, vice president and general manager, U.S. Vision Care, Bausch + Lomb. “As patient care is our primary focus, it is important to provide eye care professionals another option to meet the unique lifestyle needs of their patients. We believe Bausch + Lomb ULTRA® contact lenses deliver on these needs and are supported by clinical research to support the PMA filing.”

Bausch + Lomb fielded a 12-month, controlled, parallel group, masked, randomized study at 34 sites across the U.S. The objective was to evaluate the safety and effectiveness of the Bausch + Lomb ULTRA® samfilcon A soft (hydrophilic) contact lens, a silicone hydrogel contact lens, when worn for seven-day extended wear by adapted soft contact lens wearers.  The clinical study was submitted to the FDA as part of the PMA filing. 

Bausch + Lomb ULTRA® contact lenses, introduced to the U.S. market in 2014, are the only contact lenses to include MoistureSeal® Technology, a patented combination of material and manufacturing process, which helps to maintain 95% of lens moisture for a full 16 hours. Nine out of ten patients agree that Bausch + Lomb ULTRA® contact lenses are as comfortable at the end of the day as they are at the beginning.1 

The lenses feature polyvinylpyrrolidone (PVP) for enhanced wettability, and have the highest Dk/t (163) and lowest modulus (70) compared to the leading silicone hydrogel contacts lenses on the market. The lens also incorporates aspheric optics and spherical aberration control, designed to provide exceptional vision even in low light conditions. Bausch + Lomb ULTRA® contact lenses are also available for patients with astigmatism and presbyopia. 

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 over-the-counter supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in the industry, which is available in more than 100 countries.

References
1. Results of an online survey with patients that wore their lenses for 7+ days and on average, wore their lenses for 8 or more hours a day (n=485). Survey questions were top 3-box scores (% Strongly Agree, Agree, Slightly Agree) on a 6-point agreement scale, with a margin of error +/- 2.4%. 

Bausch + Lomb ULTRA and MoistureSeal are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2017 Bausch & Lomb Incorporated. ZUS.0206.USA.17


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