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Bausch + Lomb Corp
Symbol BLCO
Shares Issued 350,881,339
Close 2024-01-08 C$ 21.22
Market Cap C$ 7,445,702,014
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Bausch + Lomb receives FDA OK for TENEO excimer laser

2024-01-08 09:21 ET - News Release

Mr. Luc Bonnefoy reports

BAUSCH + LOMB RECEIVES FDA APPROVAL FOR TENEO(TM) EXCIMER LASER PLATFORM FOR MYOPIA AND MYOPIC ASTIGMATISM LASIK VISION CORRECTION SURGERY

The United States Food and Drug Administration (FDA) has approved Bausch + Lomb Corp.'s TENEO excimer laser platform for laser assisted in situ keratomileusis (LASIK) vision-correction surgery for myopia and myopic astigmatism (nearsightedness and nearsightedness with astigmatism).

"TENEO has been well received and is widely adopted in more than 50 countries around the world, and now U.S. ophthalmologists will benefit from this versatile laser," said Luc Bonnefoy, president, global surgical, Bausch + Lomb. "The precise engineering of this platform delivers a fast, small, technologically advanced machine that provides an exceptional experience for both surgeons and patients."

TENEO offers several unique features not offered by previous excimer laser platforms.

Accuracy

The advanced eye-tracker operates at 1,740 Hz (hertz), which is more than three times the speed of the laser's repetition. This feature helps to ensure the laser ablation pattern is not negatively impacted by a patient's eye movement and helps achieve outstanding postoperative outcomes.

The platform's high-speed laser operates at 500 Hz, the fastest ablation time of all excimer lasers available in the United States at approximately 1.2 seconds per diopter.

Efficiency

The platform's customizable graphical user interface touchscreen simplifies set up and allows surgeons to access the patient data they choose without flipping through screens.

The cutting-edge TENEO software treats the manifest refraction and does not require a nomogram, therefore streamlining surgical planning by eliminating several steps prior to treatment. The logical, intuitive process requires three steps: select patient, choose and confirm treatment, treat.

In addition to these time-saving advantages, the compact design of the TENEO (0.6 square metre (6.8 square feet)) makes it the smallest excimer laser unit available in the United States, freeing up limited clinical space, which is a critical concern for many surgeons.

Usability

TENEO has been specifically engineered for the comfort of both surgeons and patients. It features a 360-degree swivelling microscope that adapts to surgeon height and posture, aiding in surgeon comfort.

The treatment bed comfortably accommodates patients of all sizes, swings out for easier access and can be customized for optimal head positioning. The bed can be swivelled to be positioned for a second treatment device so that patients do not have to get up and move, enhancing comfort and simplifying the surgical process.

"FDA approval of TENEO represents a major milestone for the advancement of laser vision-correction technology in the United States," said George Waring IV, MD, ophthalmologist, and founder and medical director of Waring Vision Institute, Mt. Pleasant, S.C. "In addition to the technological advantages TENEO offers, the open air feeling around the laser and quiet performance contribute to a comfortable experience for the patient."

Please see the user manual for a complete list of safety information, including a full list of contraindications, warnings, precautions and risks.

About LASIK surgery

LASIK surgery is a common vision-correction procedure for people with myopia (nearsightedness), hyperopia (farsightedness) or astigmatism. An alternative to wearing glasses or contact lenses, the procedure involves using a special type of laser to change the shape of the cornea. Around 10 million Americans have had LASIK surgery since its approval in 1999, according to Marketscope. Approximately 550,000 LASIK surgeries are performed each year.

About myopia and myopic astigmatism

Myopia, or nearsightedness, is a common type of refractive error where close objects appear clearly, but distant objects appear blurry. According to the National Eye Institute, nearsightedness affects about 25 per cent of Americans and is often diagnosed in children between eight and 12 years of age, and can worsen during the teen years. Little change may occur between ages 20 to 40, but sometimes nearsightedness can worsen with age. People whose parents are nearsighted may be more likely to have the condition.

Astigmatism happens when the cornea or lens has a different shape than normal, making vision blurry. Astigmatism is common, with about one in three people having some degree of the condition, which happens along with myopia and hyperopia.

About Bausch + Lomb Corp.

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 approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ont., with corporate offices in Bridgewater, N.J.

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