Bausch + Lomb Receives 510(k) Clearance from FDA for Biotrue® Hydration Boost Contact Lens Rehydrating Drops
Bausch + Lomb (NYSE: BLCO) has received FDA 510(k) clearance for its Biotrue Hydration Boost Contact Lens Rehydrating drops. This preservative-free product is designed for soft and rigid gas permeable lenses, providing up to eight hours of moisture. With one-third of the 45 million U.S. contact lens wearers experiencing dryness, this product is expected to cater to a significant market need. The drops contain hyaluronan and match the pH of healthy tears, enhancing user comfort. Availability is anticipated in the first half of 2023.
- FDA clearance for Biotrue Hydration Boost Contact Lens Rehydrating drops.
- Product addresses dryness issue for one-third of 45 million U.S. contact lens wearers.
- Uses ingredients inspired by the biology of the eye, enhancing comfort.
- None.
Provides Lenses Up to Eight Hours of Moisture*
VAUGHAN, ON, Dec. 13, 2022 /PRNewswire/ -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) ("Bausch + Lomb"), a leading global eye health company dedicated to helping people see better to live better, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Biotrue Hydration Boost Contact Lens Rehydrating drops, a preservative-free multi-dose rehydrating drop for use with soft and rigid gas permeable contact lenses.
"We are proud to continue to build upon our successful Biotrue brand with the FDA clearance of Biotrue Hydration Boost for Contacts," said Joe Gordon, president, Global Consumer, Vision Care and Surgical, Bausch + Lomb. "Approximately, one-third of the 45 million contact lens wearers in the United States experience contact lens dryness.1-3 We look forward to making this product available during the first half of 2023 to provide lens wearers with a new contact lens drop that delivers instant moisture and provides up to eight hours of moisture."*
Inspired by the biology of the eye, Biotrue Hydration Boost Contact Lens drops contain a combination of ingredients informed by the Tear Film and Ocular Surface Society's DEWS II report including hyaluronan, a moisturizer found naturally in the eye, and other naturally inspired ingredients. Biotrue Hydration Boost for Contacts also matches the pH of healthy tears for comfort.
"Many of my patients experience dry, uncomfortable contact lenses throughout the day," said Mile Brujic, O.D., Premier Vision Group, Bowling Green, Ohio. "The availability of Biotrue Hydration Boost for Contacts will help my patients quickly reduce their contact lens-related dryness. I look forward to recommending this product to patients as soon as it is available next year."
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Twitter, LinkedIn, Facebook and Instagram.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb's filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
*Based on a laboratory study
References
- Multi-Sponsor Surveys Inc. The 2019 Study of the U.S. Consumer Contact Lens Market. January 2020.
- American Optometric Association. www.aoa.org.
- Centers for Disease Control and Prevention. www.cdc.gov.
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FAQ
What is the significance of Bausch + Lomb's FDA clearance on December 13, 2022?
When will Biotrue Hydration Boost for Contacts be available to consumers?
What percentage of contact lens wearers experience dryness?
What key ingredient is used in Biotrue Hydration Boost for comfort?
How does Biotrue Hydration Boost help contact lens wearers?
