Two New OVDs Offer Surgeons Dual-Action
Protection during Cataract Surgery
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)
CONTRAINDICATIONS
There are no contraindications to the use of ClearVisc,
StableVisc and TotalVisc when used as a surgical aid
in ophthalmic anterior segment procedures.
PRECAUTIONS
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.
WARNINGS
- 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.
ADVERSE REACTIONS
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.
ATTENTION
Refer to the Directions for Use labeling for a complete listing
of indications, warnings and precautions, clinical trial
information, etc.
CAUTION
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.
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 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.
References
- 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.
© 2023 Bausch & Lomb Incorporated or its affiliates.
MTB.0103.USA.23
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230424005102/en/
Investor: Arthur Shannon arthur.shannon@bausch.com
Allison Ryan Allison.ryan@bausch.com (877) 354-3705 (toll free)
(908) 927-0735 Media: Lainie Keller lainie.keller@bausch.com
(908) 927-1198 Kristy Marks kristy.marks@bausch.com (908)
927-0683
Bausch plus Lomb (NYSE:BLCO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Bausch plus Lomb (NYSE:BLCO)
Historical Stock Chart
From Jul 2023 to Jul 2024