Bausch + Lomb Enrolls First Patient in LASIK Clinical Trial Evaluating Use of Technolas® TENEO™ Excimer Laser* for Vision Correction Surgery for Hyperopia with Astigmatism
Study Intended to Support FDA Pre-Market Approval Filing
"The initiation of this study is an important step toward our goal of bringing the Technolas® TENEO™ excimer laser to
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,
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
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
*The Technolas® TENEO™ excimer laser is currently being sold outside of
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.
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates.
All other product/brand names and/or logos are trademarks of the respective owners.
© 2022 Bausch & Lomb Incorporated or its affiliates.
TEN.0003.USA.22
|
Investor Contacts: |
Media Contacts: |
|
Arthur Shannon |
Lainie Keller |
|
(908) 927-1198 |
|
|
Allison Ryan |
|
|
Kristy Marks |
|
|
(877) 354-3705 (toll free) |
|
|
(908) 927-0735 |
(908) 927-0683 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/bausch--lomb-enrolls-first-patient-in-lasik-clinical-trial-evaluating-use-of-technolas-teneo-excimer-laser-for-vision-correction-surgery-for-hyperopia-with-astigmatism-301592969.html
SOURCE Bausch + Lomb Corporation
