Study Intended to Support FDA Pre-Market Approval Filing
VAUGHAN, ON, July 26, 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 the company has enrolled the first patient in a study evaluating the safety and efficacy of the Technolas® TENEO™ excimer laser* for laser-assisted in situ keratomileusis (LASIK) vision correction surgery for hyperopia with astigmatism.
"The initiation of this study is an important step toward our goal of bringing the Technolas® TENEO™ excimer laser to the United States, where, if approved, it could become the first significant LASIK innovation in more than a decade," said Joe Gordon, president, Global Consumer, Surgical and Vision Care, Bausch + Lomb. "The TENEO™ laser has been well received and is widely adopted in more than 50 markets around the world as one of the most versatile lasers available with a compact footprint."
The multicenter, prospective, single arm, open-label, non-randomized clinical study will include up to 334 operative (study) eyes undergoing LASIK surgery for correction of hyperopia and hyperopic astigmatism. Investigators will determine safety and efficacy endpoints through a series of post-operative visits up to 24 months based on post-surgical observation.
"The demand for LASIK vision correction has risen significantly among our patients over the past few years, and refractive surgeons want options that meet the needs of their patients," said Ralph Chu, M.D., study investigator, and founder and medical director of Chu Vision Institute and Chu Surgery Center, Bloomington, Minn. "This study represents an exciting opportunity to evaluate new technology that has the potential to help more hyperopic patients."
About LASIK Surgery
LASIK surgery is a common vision correction procedure for people with myopia (nearsightedness), hyperopia (farsightedness) or astigmatism.1 An alternative to wearing glasses or contact lenses, the procedure involves using a special type of laser to change the shape of the cornea.1 Around 10 million Americans have had LASIK surgery since its approval in 1999 according to Marketscope.2 Approximately 700,000 LASIK surgeries are performed each year.
About Hyperopia and Astigmatism
Hyperopia occurs when the eye does not refract or bend light properly, causing objects in the distance to appear clear, but nearby objects to appear blurry. According to the National Eye Institute, hyperopia can run in families, and affects approximately five to 10 percent of Americans.3
Astigmatism happens when the cornea or lens has a different shape than normal, making vision blurry.4 Astigmatism is common, with about one in three people having some degree of the condition, which happens along with farsightedness and nearsightedness (myopia).5
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.
*The Technolas® TENEO™ excimer laser is currently being sold outside of the United States as Technolas® TENEO™ laser 317 (model 2). The device is investigational use only and not approved in the United States or its territories.
References
- Mayo Clinic Web site, About LASIK Surgery. Accessed May 9, 2022. https://www.mayoclinic.org/tests-procedures/lasik-eye-surgery/about/pac-20384774
- WebMD: LASIK Surgery: Know the Rewards and Risks. Accessed May 9, 2022. https://www.webmd.com/eye-health/news/20180727/lasik-know-the-rewards-and-the-risks.
- National Eye Institute fact sheet on farsightedness. Accessed May 9, 2022. https://www.nei.nih.gov/sites/default/files/health-pdfs/Farsightedness.pdf.
- National Eye Institute: Astigmatism: At a Glance. Accessed May 9, 2022. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/astigmatism.
- Cleveland Clinic: Astigmatism. Accessed May 9, 2022. https://my.clevelandclinic.org/health/diseases/8576-astigmatism#:~:text=How%20common%20is%20astigmatism%3F,along%20with%20nearsightedness%20or%20farsightedness.
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