One Podium Presentation and 11 Poster Presentations to be
Featured
LAVAL, QC, April 29, 2021
/CNW/ -- Bausch + Lomb, a leading global eye health
business of Bausch Health Companies Inc. (NYSE/TSX: BHC)
("Bausch Health"), today announced the presentation of new
scientific data and clinical analyses, including one podium
presentation and 11 poster presentations, during the virtual
Association for Research in Vision and Ophthalmology (ARVO) annual
meeting, which will take place from May 1-7,
2021. The virtual presentations will feature several of the
company's prominent products from its pharmaceutical, surgical and
vision care portfolios, as well as data from the company's ongoing
Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR)
surveillance study. Analyses on the company's investigational
drug XIPERE™ (triamcinolone acetonide suprachoroidal
injectable suspension) will also be highlighted.1
"The new data and analyses we are presenting at ARVO this year
represent our ongoing commitment to research and development across
our business and to providing practitioners with new information
that can help inform the treatment and care of their patients,"
said Joe Gordon, U.S. president,
Bausch + Lomb. "Among the data to be featured are insights from our
ARMOR surveillance study, which continues to be the only ongoing
multicenter study in the United
States that monitors in vitro antibiotic resistance among
ocular pathogens, and data on XIPERE™. We are proud to
support these important studies and share the latest findings with
eye care professionals during the ARVO meeting."
The ARMOR study analyses will be featured in both a podium
presentation, examining the antibiotic resistance trends among
staphylococcal isolates collected in the ARMOR study since 2009,
and a poster presentation outlining the preliminary analysis of the
2020 ARMOR results. The ARMOR study findings allow eye care
professionals to track in vitro susceptibility rates for commonly
used antibiotics.
Another poster from the company's vision care portfolio will
evaluate the osmoprotective effects of the Bausch + Lomb INFUSE™
silicone hydrogel (SiHy) daily disposable contact lenses packaging
lens solution, kalifilcon A(KA), as compared to six other SiHy
daily disposable packaging solutions. Bausch + Lomb INFUSE lenses
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) in August
2020.
From the company's surgical portfolio, one poster will evaluate
the increased hydroxyl radical scavenging activity of ClearVisc™
dispersive ophthalmic viscosurgical device (OVD) and a cohesive
OVD. Bausch + Lomb announced the FDA approval of ClearVisc in
April. A second poster will analyze the acoustic pressure of 23-,
25- and 27-gauge vitrectomy needles to measure the power,
energy-tissue interaction and safety of Vitesse™ ultrasonic device,
and another poster will compare the optical performance of
intraocular lenses (IOLs) with three optical designs using an
optical raytracing simulation method.
Four other posters will feature new data from the Bausch + Lomb
pharmaceuticals portfolio. The first will feature findings from the
company's pharmacovigilance database of the occurrence of
steroid-associated adverse events related to
LOTEMAX® SM (loteprednol etabonate ophthalmic gel)
0.38% and all other LOTEMAX® formulations. Another will
evaluate the differences in dose uniformity between
LOTEMAX® SM and another corticosteroid suspension
product when shaken or not shaken.
The last two pharmaceutical posters will feature data on
blepharitis, which is an inflammation of the eyelids that makes
them red, irritated and itchy with dandruff-like scales that form
on the eyelashes. One will evaluate the in vitro activity of
tobramycin, the antibacterial in ZYLET® (loteprednol
etabonate 0.5% and tobramycin 0.3% ophthalmic suspension), against
common bacterial pathogens associated with the disorder, and the
other will compare the in vitro activity of eight antibiotics
across six drug classes frequently used to manage blepharitis
caused by staphylococci ("staph" bacteria).
The remaining two posters, which will be presented by Clearside
Biomedical, Inc., will feature unpublished data on the
investigational drug, XIPERE™. The first poster, a post hoc study,
will evaluate the safety of suprachoroidal injections (SCIs)
utilizing the SCS Microinjector® across multiple
clinical trials, and the other poster will analyze the procedural
characteristics of SCIs in two non-infectious uveitis trials.
The full schedule of research (by date) to be presented
includes:
Sunday, May 2
- "Monofocal, Diffractive Trifocal and EDOF IOLs." Xie et
al.
- "New Ophthalmic Viscosurgical Device (OVD) with Enhanced
Hydroxyl Radical Scavenging Activity." Erb et al.
Monday, May 3
- "Analysis of Longitudinal Antibiotic Susceptibility Trends
in Staphylococci: Results from 12 Years of the ARMOR Study."
Asbell et al.
- "Post hoc Analysis of Clinical Suprachoroidal Injection
Experience for Non-infectious Uveitis." Shah, M.
- "Safety of Suprachoroidal Injection Procedure Utilizing a
Microinjector across Three Retinal Disorders." Sharma, S.
Tuesday, May 4
- "In Vitro Potency of Tobramycin Against Common Bacterial
Pathogens Implicated in Blepharitis." Deom et al.
Thursday, May 6
- "Acoustic power measurements of ultrasonic vitrectomy device
and the effects in pig eyes." Papour et al.
Friday, May 7
- "Dose uniformity of loteprednol etabonate (submicron)
ophthalmic gel 0.38% compared with prednisolone acetate ophthalmic
suspension 1.0%." Marlowe et al.
- "Occurrence of steroid-associated adverse events with
loteprednol etabonate formulations." Cavet et al.
- "Interim Analysis of Antibiotic Resistance from Bacterial
Pathogens Collected in the 2020 ARMOR Study." Sanfilippo et
al.
- "Comparative In Vitro Activity of Antibiotics Frequently
Used in the Management of Staphylococcal Blepharitis." Kissling
et al.
- "Comparative Analysis of the Osmoprotective Effects of a
Novel Contact Lens Packaging Solution on Human Corneal Epithelial
Cells." Byrnes et al.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR CLEARVISC™
OVD
INDICATIONS FOR USE
ClearVisc™ is indicated for use as
a surgical aid 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™ 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.
- An excess quantity of ClearVisc™ should not be used. Excess OVD
can cause increased intraocular pressure.
- ClearVisc™ 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 ClearVisc™
is injected. It is recommended that a single-use disposable cannula
be used when administering ClearVisc™. 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™ 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.
Indication and Important Safety Information about
LOTEMAX® SM (loteprednol etabonate ophthalmic gel)
0.38%
LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%
is a corticosteroid indicated for the treatment of post-operative
inflammation and pain following ocular surgery.
IMPORTANT SAFETY INFORMATION
- LOTEMAX® SM, as with other ophthalmic
corticosteroids, is contraindicated in most viral diseases of the
cornea and conjunctiva including epithelial herpes simplex
keratitis (dendritic keratitis), vaccinia, and varicella, and also
in mycobacterial infection of the eye and fungal diseases of ocular
structures.
- Prolonged use of corticosteroids may result in glaucoma with
damage to the optic nerve, defects in visual acuity and fields of
vision. Steroids should be used with caution in the presence of
glaucoma. If LOTEMAX® SM is used for 10 days or longer,
IOP should be monitored.
- Use of corticosteroids may result in posterior subcapsular
cataract formation.
- The use of steroids after cataract surgery may delay healing
and increase the incidence of bleb formation. In those with
diseases causing thinning of the cornea or sclera, perforations
have been known to occur with the use of topical steroids. The
initial prescription and renewal of the medication order should be
made by a physician only after examination of the patient with the
aid of magnification such as slit lamp biomicroscopy and, where
appropriate, fluorescein staining.
- Prolonged use of corticosteroids may suppress the host response
and thus increase the hazard of secondary ocular infections. In
acute purulent conditions, steroids may mask infection or enhance
existing infections.
- Employment of a corticosteroid medication in the treatment of
patients with a history of herpes simplex requires great caution.
Use of ocular steroids may prolong the course and may exacerbate
the severity of many viral infections of the eye (including herpes
simplex).
- Fungal infections of the cornea are particularly prone to
develop coincidentally with long-term local steroid application.
Fungus invasion must be considered in any persistent corneal
ulceration where a steroid has been used or is in use. Fungal
cultures should be taken when appropriate.
- Contact lenses should not be worn when the eyes are
inflamed.
- There were no treatment-emergent adverse drug reactions that
occurred in more than 1% of subjects in the three times daily group
compared to vehicle.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Click here for full Prescribing Information for
LOTEMAX® SM.
Indication and Important Safety Information about ZYLET
(loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic
suspension)
ZYLET® (loteprednol etabonate 0.5%
and tobramycin 0.3% ophthalmic suspension) is a topical
anti-infective and corticosteroid combination for
steroid-responsive inflammatory ocular conditions for which a
corticosteroid is indicated and where superficial bacterial ocular
infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva, cornea and anterior segment of
the globe such as allergic conjunctivitis, acne rosacea,
superficial punctate keratitis, herpes zoster keratitis, iritis,
cyclitis, and where the inherent risk of steroid use in certain
infective conjunctivitis is accepted to obtain a diminution in
edema and inflammation. They are also indicated in chronic anterior
uveitis and corneal injury from chemical, radiation or thermal
burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component
is indicated where the risk of superficial ocular infection is high
or where there is an expectation that potentially dangerous numbers
of bacteria will be present in the eye.
The particular anti-infective drug in this product (tobramycin)
is active against the following common bacterial eye pathogens:
Staphylococci, including S. aureus and S. epidermidis
(coagulase-positive and coagulase-negative), including
penicillin-resistant strains. Streptococci, including some of the
Group A-beta-hemolytic species, some nonhemolytic species, and some
Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia
coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus
mirabilis, Morganella morganii, most Proteus vulgaris
strains, Haemophilus influenzae, and H. aegyptius, Moraxella
lacunata, Acinetobacter calcoaceticus and some Neisseria
species.
IMPORTANT SAFETY INFORMATION
ZYLET is contraindicated
in most viral diseases of the cornea and conjunctiva including
epithelial herpes simplex keratitis (dendritic keratitis),
vaccinia, and varicella, and also in mycobacterial infection of the
eye and fungal diseases of ocular structures.
- Prolonged use of corticosteroids may result in glaucoma with
damage to the optic nerve, defects in visual acuity and fields of
vision. Steroids should be used with caution in the presence of
glaucoma. If this product is used for 10 days or longer,
intraocular pressure should be monitored.
- Use of corticosteroids may result in posterior subcapsular
cataract formation.
- The use of steroids after cataract surgery may delay healing
and increase the incidence of bleb formation. In those diseases
causing thinning of the cornea or sclera, perforations have been
known to occur with the use of topical steroids. The initial
prescription and renewal of the medication order should be made by
a physician only after examination of the patient with the aid of
magnification such as a slit lamp biomicroscopy and, where
appropriate, fluorescein staining.
- Prolonged use of corticosteroids may suppress the host response
and thus increase the hazard of secondary ocular infections. In
acute purulent conditions, steroids may mask infection or enhance
existing infections. If signs and symptoms fail to improve after 2
days, the patient should be re-evaluated.
- Employment of corticosteroid medication in the treatment of
patients with a history of herpes simplex requires great caution.
Use of ocular steroids may prolong the course and exacerbate the
severity of many viral infections of the eye (including herpes
simplex).
- Fungal infections of the cornea are particularly prone to
develop coincidentally with long-term local steroid application.
Fungus invasion must be considered in any persistent corneal
ulceration where a steroid has been used or is in use.
- Most common adverse reactions reported in patients were
injection and superficial punctate keratitis, increased intraocular
pressure, burning and stinging upon instillation.
You are encouraged to report side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for Prescribing Information for ZYLET.
About Bausch + Lomb
Bausch + Lomb, a leading global
eye health business of Bausch Health Companies Inc., is solely
focused on helping people see. Its core businesses include
over-the-counter products, dietary supplements, eye care products,
ophthalmic pharmaceuticals, contact lenses, lens care products,
ophthalmic surgical devices and instruments. Bausch + Lomb
develops, manufactures and markets one of the most comprehensive
product portfolios in the industry, which is available in
approximately 100 countries. For more information, visit
www.bausch.com.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. More information can be found at
www.bauschhealth.com.
Forward-looking Statements
This news release may
contain forward-looking statements, which may generally be
identified by the use of the words "anticipates," "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 Health's most recent
annual report on Form 10-K and detailed from time to time in Bausch
Health's other 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
Health, including but not limited to its project development
timelines, 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 Health 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.
References
1. In October
2019, an affiliate of Bausch Health acquired an exclusive
license from Clearside Biomedical for the commercialization and
development of XIPERE in the United
States and Canada.
®/™ are trademarks of Bausch &
Lomb Incorporated or its affiliates.
All other product/brand names and/or logos are trademarks of the
respective owners.
© 2021 Bausch & Lomb Incorporated or its affiliates,
except SCS Microinjector is a trademark of Clearside Biomedical,
Inc.
MTB.0137.USA.21
Investor
Contact:
|
Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@bauschhealth.com
|
lainie.keller@bauschhealth.com
|
(514)
856-3855
|
(908)
927-1198
|
(877) 281-6642 (toll
free)
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/bausch--lomb-will-present-new-scientific-data-and-analyses-on-products-and-pipeline-programs-during-the-association-for-research-in-vision-and-ophthalmology-meeting-301279926.html
SOURCE Bausch Health Companies Inc.