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BAUSCH + LOMB RECEIVES 510(K) CLEARANCE FROM FDA FOR THE THERAPEUTIC USE OF BOSTON XO® AND BOSTON XO2® MATERIALS
Expanded Indication Provides Treatment for Multiple
Ocular Surface Conditions Including Dry Eye
BRIDGEWATER, New Jersey, Aug. 9, 2017 – Bausch + Lomb, a leading global eye health company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the therapeutic use of its Boston XO® and Boston XO2® materials in treating several ocular surface diseases. The Boston XO® and Boston XO2® gas permeable materials are used in a broad spectrum of custom specialty lenses including the Zenlens™ scleral lens from Alden Optical, a part of the Bausch + Lomb Specialty Vision Products business, and are also indicated for daily wear for the correction of refractive ametropia and the management of irregular corneal conditions.
“When considering new innovative ways to advance our contact lenses, we always keep eye care professionals and their patient’s top of mind. Ultimately, we strive to improve the fitting experience and outcomes for both parties,” said David Bland, director, Specialty Vision Products, Bausch + Lomb. “We are excited to be able to potentially treat multiple serious ocular surface diseases with custom lenses manufactured with our Boston XO® and Boston XO2® materials. While many of these conditions don’t have a high prevalence of occurrence, we are committed to ensuring that our customers have a therapeutic option for the eye conditions their patients may have.”
The expanded indication enables scleral lenses manufactured with the Boston XO® and Boston XO2® gas permeable materials to be utilized in the treatment of certain ocular surface conditions, including dry eye disease, which affects millions of people in the U.S., as well as limbal stem cell deficiencies, skin disorders with ocular surface manifestations, neurotrophic keratitis, corneal exposure that may benefit from the presence of an expanded tear reservoir and the saline-hydrated environment inherent in a scleral lens design.
“While some eye diseases may be considered rare, it is important that we as eye care professionals have the necessary tools to treat them,” said Jason Jedlicka, O.D., FAAO, FSLS, FCLSA, clinical associate professor at Indiana University School of Optometry and director of the Cornea and Contact Lens Service. “I am grateful that Bausch + Lomb continues to develop and expand upon its product portfolio to meet the various needs of my patient’s vision challenges, particularly those who require a scleral lens with therapeutic options for rare, but serious, eye conditions.”
Ocular surface disease is characterized by a dysfunction of the ocular tear film and/or the ocular surface. These changes may result in a wide range of symptoms and signs that might include discomfort, burning, fatigue, fluctuating visual acuity, infection, ulceration, scarring of the ocular surface, and possible loss of vision.
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.
Boston XO, Boston XO2, and Zenlens are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2017 Bausch & Lomb Incorporated.
SCL.0016.USA.17
United States
