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 particular 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 associated with 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 Eyesight Care, Bausch + Lomb. “The TENEO ™ laser offers been well received and is widely adopted in a lot more than 50 markets around the world as one of the most versatile lasers available along with a compact footprint. ”
The multicenter, prospective, single arm, open-label, non-randomized clinical study will include up in order to 334 operative (study) eyes undergoing LASIK surgery with regard to correction of hyperopia and hyperopic astigmatism. Investigators will determine security and effectiveness 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, plus refractive surgeons want options that meet the needs of their patients, inch said Ralph Chu , M. D., study investigator, and founder and medical director associated with Chu Vision Institute and Chu Surgical treatment Center, Bloomington, Minn. “This study represents an exciting opportunity to evaluate new technology that has the potential to help more hyperopic patients. ”
About LASIK Surgical procedure
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 the special type of laser to change the shape of the cornea. one Around 10 million Americans have had LASIK surgery since its approval within 1999 according to Marketscope. 2 Approximately 700, 000 LASIK surgeries are performed each year.
Regarding Hyperopia plus Astigmatism
Hyperopia occurs when the vision does not refract or bend light properly, causing objects in the distance to appear clear, but nearby objects to appear blurry. According in order to the National Eye Institute, hyperopia can run in families, and affects approximately five to 10 percent of People in america. 3
Astigmatism happens when the particular cornea or lens provides a different shape than normal, making vision fuzzy. 4 Astigmatism is common, with about one within three people having some degree of the condition, which happens along with farsightedness and nearsightedness (myopia). 5
About Bausch + Lomb
Bausch + Lomb is focused on protecting plus enhancing the particular gift associated with sight regarding millions of people around the world – from the moment of birth through every phase associated with life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, attention care products, ophthalmic pharmaceuticals, over-the-counter items and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with more compared to 12, 500 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered within Vaughan, Ontario with corporate offices in Bridgewater, New Jersey . For more information, visit www.bausch.com plus connect along with us upon Twitter , LinkedIn , Facebook and Instagram .
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*The Technolas ® TENEO ™ excimer laser is currently being sold outside of the usa as Technolas ® TENEO ™ laser beam 317 (model 2). The device is investigational use only and not approved in the United States or its territories.
Mayo Clinic Web site, About LASIK Surgery. Accessed May 9 , 2022. https://www.mayoclinic.org/tests-procedures/lasik-eye-surgery/about/pac-20384774
WebMD: LASER EYE SURGERY Surgery: Know the Rewards and Risks. Accessed Might 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 Vision Institute: Astigmatism: At the Glance. Utilized May nine, 2022 . https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/astigmatism .
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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