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 associated with the Technolas ® TENEO excimer laser* for laser-assisted within 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 plus Vision Care, Bausch + Lomb. “The TENEO laser beam has been well received and is widely adopted within more than 50 markets around the particular world as one of the most versatile lasers available with the compact footprint. ”

The multicenter, prospective, single arm, open-label, non-randomized clinical study will include up to 334 operative (study) eyes  undergoing LASIK surgical treatment 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 LASER EYE SURGERY vision modification has risen significantly among our patients over the past few years, and refractive surgeons want options that meet the particular needs of their individuals, ” said Ralph Chu , M. D., research investigator, plus founder and medical director of Chu Vision Institute and Chu Surgery Center, Bloomington, Minn. “This study represents an exciting opportunity in order to evaluate new technology that has the potential to  help more hyperopic patients.  

About LASIK Surgery
LASER EYE SURGERY surgery is a common vision correction procedure with regard to people with myopia (nearsightedness), hyperopia (farsightedness) or astigmatism. 1 An alternative to wearing glasses or contact lenses, the procedure involves using a special type associated with laser in order 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 LASER EYE SURGERY surgeries are performed each year.

About Hyperopia and Astigmatism
Hyperopia  occurs when the eye does not refract or even bend light properly, causing objects in the distance to appear clear, but nearby objects to appear blurry. According to the particular 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 eyesight blurry. 4 Astigmatism is common, with about one in three people having  some degree associated with the condition, which happens along with farsightedness plus 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 particular moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye maintenance systems, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant worldwide research plus 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, inch “hopes, ” “expects, inch “intends, ” “plans, inch “should, ” “could, inch “would, ” “may, inch “believes, ” “estimates, inch “potential, ” “target, inch or “continue” and variations or similar expressions. These statements are usually based upon the current expectations and beliefs of management and are subject to certain risks plus uncertainties that will could cause actual results to differ materially from those described within the forward-looking statements. These risks and uncertainties include, but are not limited to, the particular risks and uncertainties discussed in Bausch + Lomb’s filings with the U. S. Securities plus Exchange Commission and the Canadian Securities Administrators, which factors are usually incorporated herein by reference. They also include, but are not restricted to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the particular fear of that pandemic plus its possible effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which might have the material adverse impact on Bausch + Lomb, including yet not limited to its project development timelines, launches and costs (which may increase). Readers are usually cautioned not to place undue reliance on any associated with these forward-looking statements. These types of forward-looking claims 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 day of this news release or even to reveal actual outcomes, unless required by law.  

*The Technolas ® TENEO excimer laser will be currently being sold outside associated with the usa as Technolas ® TENEO laser 317 (model 2). The device is investigational use just and not authorized in the particular United States or its territories.

References

  1. Mayo Clinic Web site, About LASIK Surgical treatment.   Accessed May 9 , 2022.   https://www.mayoclinic.org/tests-procedures/lasik-eye-surgery/about/pac-20384774
  2. WebMD: LASIK Surgical procedure: Know the Rewards and Risks. Accessed May 9 , 2022.   https://www.webmd.com/eye-health/news/20180727/lasik-know-the-rewards-and-the-risks .
  3. National Vision Institute fact sheet upon farsightedness. Utilized May nine, 2022 . https://www.nei.nih.gov/sites/default/files/health-pdfs/Farsightedness.pdf .  
  4. National Eye Company: Astigmatism: At a Glance. Accessed Might 9, 2022 . https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/astigmatism .  
  5. Cleveland Medical center: Astigmatism. Seen 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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SOURCE Bausch + Lomb Company

 

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