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 the U.S. launch of StableVisc™ cohesive ophthalmic viscosurgical device (OVD) as well as TotalVisc™ Viscoelastic System. StableVisc and TotalVisc provide eye surgeons with new options for dual-action protection during cataract surgery.
“OVDs are critical to surgeons’ success when performing cataract surgery, which is one of the most common surgical procedures performed in the United States. StableVisc and TotalVisc provide surgeons with new OVD options that offer unique benefits designed to help ensure the best possible surgical outcomes for patients,” said Joe Gordon, president, Global Consumer, Surgical and Vision Care, Bausch + Lomb.
StableVisc, a cohesive OVD, helps maintain space in the anterior chamber of the eye to allow surgeons to extract and replace the clouded natural lens. TotalVisc Viscoelastic System includes both StableVisc and ClearVisc™, a dispersive OVD, and protects ocular tissue during the surgical procedure. ClearVisc was approved by the U.S. Food and Drug Administration in 2021.
StableVisc and ClearVisc both contain sodium hyaluronate and sorbitol, a unique chemical agent that has been shown to create a strong physical barrier and deliver increased free radical scavenging capabilities compared to other OVDs tested in a laboratory study.2,3* TotalVisc OVD provides dual-action mechanical and chemical protection. TotalVisc is the only dual pack in the United States that includes a dispersive and cohesive OVD formulated with sorbitol.
Free radicals form as a result of chemical reactions caused during various steps of cataract surgery, including phacoemulsification, irrigation/aspiration and as part of the insertion and removal of instruments and implants. Free radicals can contribute to corneal damage and possible decompensation, which can lead to post-surgical complications such as a cloudy cornea.
“The possibility of complications caused by free radical damage is a real concern both during and after cataract surgery,” said Mitch Shultz, M.D., cornea, cataract and refractive surgeon and medical director, Shultz Chang Vision, Los Angeles. “The dual protection provided by ClearVisc dispersive OVD and StableVisc cohesive OVD gives me added confidence that I am doing everything I can to make my surgeries as safe and efficient as possible and give my patients excellent outcomes. I look forward to having access to both a cohesive and a dispersive OVD that offer these important benefits.”
In addition to providing increased free radical protection, StableVisc leads the cohesive OVD segment in fill volume at one milliliter, which reduces the need to open a second pack mid-procedure, thus contributing to surgical efficiency. TotalVisc also leads the dual pack OVD segment in fill volume of device with one milliliter of both ClearVisc and StableVisc.
Indications and Important Safety information for ClearVisc, StableVisc and TotalVisc OVDs
INDICATIONS FOR USE
ClearVisc, StableVisc and TotalVisc OVDs are indicated for use as surgical aids in ophthalmic anterior segment procedures including: Extraction of a cataract; Implantation of an intraocular lens (IOL)
There are no contraindications to the use of ClearVisc, StableVisc and TotalVisc when used as a surgical aid in ophthalmic anterior segment procedures.
Precautions normally considered during anterior segment procedures are recommended. Pre-existing glaucoma may place patients at risk for increases in intraocular pressure from the OVD during the early postoperative period.
- Do not use if the sterile barrier has been breached. Sterility cannot be guaranteed, and the patient will be at increased risk for infection.
- Do not use the OVD in subjects with known allergies to any of its components.
- An excess quantity of OVD should not be used. Excess OVD can cause increased intraocular pressure.
- The OVD should be removed from the anterior chamber at the end of surgery to prevent or minimize postoperative intraocular pressure increases (spikes). OVD remaining in the eye can cause increased intraocular pressure.
- If the postoperative intraocular pressure increases above expected values, corrective therapy should be administered. Increased intraocular pressure may lead to inflammation or vision loss.
- Do not re-use the cannula. Even after cleaning and rinsing, resterilized cannula could release particulate matter as the OVD is injected. It is recommended that a single-use disposable cannula be used when administering the OVD. Reuse may cause eye inflammation.
- If any particulate matter is observed, it should be removed by irrigation and/or aspiration. Particulate matter left in the eye may cause increased IOP or Light scattering /obstruction.
- Store at 2° to 8°C (36° to 46°F). Protect from freezing. The shelf life of ClearVisc, StableVisc and TotalVisc is not guaranteed if it is not properly stored.
Sodium hyaluronate is a natural component of tissues within the body and is generally well tolerated in human eyes. Transient postoperative inflammatory reactions and increases in intraocular pressure have been reported. Inflammation may result from increased intraocular pressure caused by use of the OVD. Intraocular inflammation, i.e., toxic anterior segment syndrome (TASS), has been attributed to OVDs. Furthermore, vision loss may be possible as a result of increased intraocular pressure and inflammation.
Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.
Federal (USA) law restricts this device to the sale by or on the order of a physician.
About Cataracts and Cataract Surgery
A clouding of the normally clear lens of the eye most commonly caused by aging,4 cataracts are a leading cause of vision loss in the United States and the leading cause of blindness worldwide.5 In the U.S., more than 20 million people aged 40 years and older have a cataract, and more than 6 million of these Americans undergo surgery to have the lens removed.5 An ophthalmic surgeon removes the cloudy lens and replaces it with a clear, artificial implant called an intraocular lens (IOL).6 According to the U.S. National Eye Institute, cataract surgery is one of the safest, most common and effective surgical procedures performed in the United States.7 In most cases, people experience improved vision after the procedure.7
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 approximately 13,000 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.
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.
*Compared to ProVisc, Viscoat, Healon Pro, Healon Endocoat, AmVisc, and AmVisc Plus.
- Rossi T, Romano MR, Iannetta D, Romano V, Gualdi L, D’Agostino I, Ripandelli G. Cataract surgery practice patterns worldwide: a survey. BMJ Open Ophthalmol. 2021 Jan 13;6(1):e000464. doi: 10.1136/bmjophth-2020-000464. PMID: 33501377; PMCID: PMC7812090.
- Data on File. Bausch & Lomb Incorporated, 2023.
- Francesco Maugeri, Adriana Maltese, Keith W. Ward & Claudio Bucolo (2007). Hydroxyl Radical Scavenging Activity of a New Ophthalmic Viscosurgical Device, Current Eye Research, 32:2, 105-111, DOI:10.1080/02713680601147716.
- American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-
health/diseases/what-are- cataracts. Accessed March 2, 2023.
- U.S. Centers for Disease Control and Prevention Web site, Vision Health Initiative (VHI). Retrieved from https://www.cdc.gov/
visionhealth/basics/ced/index. html#:~:text=external%20icon-, Cataract,can%20be%20present% 20at%20birth. Accessed March 2, 2023.
- American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-
health/diseases/what-is- cataract-surgery. Accessed March 2, 2023.
- National Eye Institute Website. Retrieved from https://www.nei.nih.gov/learn-
about-eye-health/eye- conditions-and-diseases/ cataracts/cataract-surgery. Accessed March 2, 2023.
StableVisc, TotalVisc and ClearVisc are trademarks of Bausch & Lomb Incorporated or its affiliates.
All other product/brand names and/or logos are trademarks of the respective owners.
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