Presentations Will Feature Studies
Evaluating TENEO™ Excimer Laser Platform, MIEBO®
(Perfluorohexyloctane Ophthalmic Solution) and enVista® Envy* and
IC-8® Apthera™ IOLs
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye
health company dedicated to helping people see better to live
better, today announced fifteen podium and four poster
presentations during the American Society of Cataract and
Refractive Surgery (ASCRS) annual meeting, which will take place in
Boston, April 5-8, 2024.
Podium presentations include the results of studies evaluating
the new TENEO Excimer Laser Platform, enVista and IC-8 Apthera
intraocular lenses (IOLs) and MIEBO. MIEBO is indicated for the
treatment of the signs and symptoms of dry eye disease. Poster
presentations include the results of TENEO and IC-8 Apthera IOL
studies.
In addition to these scientific presentations, the company will
also sponsor educational events focused on these and other Bausch +
Lomb products.
Bausch + Lomb activities at ASCRS:
Podium Presentations
- “Assessment of the Spectacle Independence and Visual Outcomes
Following Bilateral Implantation of a Novel Toric IOL* Among
Cataract Patients.” Harasymowycz et al.
- “Binocularity and Stereoacuity in Modern Monovision with a
Small-Aperture IOL.” Wiley et al.
- “Characterization of Discontinuation and Switching Patterns of
Dry Eye Disease Medications Using Linked EHR Registry and Claims
Data.” Mbagwu et al.
- “Clinical Results of Small-Aperture IOL Implantation Following
Corneal Inlay Removal.” Ang et al.
- “Defocus Curve Performance of a Novel Hydrophobic Acrylic
Trifocal Intraocular Lens*: A Prospective, Multicenter Canadian
Study.” Muzychuk et al.
- “Early Real World Outcomes of Small Aperture IOL in Post
Refractive Eyes.” Hu et al.
- “Outcomes of an Ultra-Low Cylinder Powered (0.90 D) Toric
versus Non-Toric IOL in Low Astigmatic Patients Undergoing Cataract
Surgery.” Muzychuk et al.
- “Patient-Reported Instillation Comfort and Eyedrop
Acceptability of Perfluorohexyloctane Ophthalmic Solution in
Pivotal Clinical Studies.” White et al.
- “Patient-Reported Outcomes Following LASIK, Performed Using a
Novel Excimer Laser for the Correction of Myopia and Myopic
Astigmatism.” Stonecipher et al.
- “Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease:
Efficacy Among Various Participant Subgroups in Pivotal Clinical
Trials.” Sheppard et al.
- “Predicted In-Vitro versus In-vivo Measurements of Higher-Order
Corneal Aberrations following Apthera Implantation Post Radial
Keratotomy.” Devaro et al.
- “Quality of Vision and Clinical Outcomes of a Novel Trifocal
IOL* Implanted Bilaterally After Cataract Surgery: A Canadian
Multicenter Study.” Harasymowycz et al.
- “Subjective versus Objective Depth of Focus from Ray-Tracing
Aberrometry in Small Aperture Optics Intraocular Lens in Eyes with
Aberrated Corneas.” Barros et al.
- “Visual and Refractive Outcomes following Bilateral
Implantation of a Novel Trifocal* or Monofocal IOL: A Prospective,
Multicenter US study.” Liang et al.
- “Visual Performance of Negative versus Neutral Aspheric
Monofocal Intraocular Lenses: A Randomized Controlled Trial.”
Kudrna et al.
Poster Presentations
- “Binocular Visual Outcomes and Defocus Curve of Bilaterally
Implanted Novel Trifocal Intraocular Lens*: A Prospective,
Multicenter US study.” Shultz et al.
- “Estimation of Visual Benefit with IC-8 in Keratoconus
Patients.” Klyce et al.
- “Initial Results Using Small Aperture Optics IOL in Patients
with or without Prior Ocular Surgery, Corneal Scarring or Irregular
Astigmatism.” Shultz et al.
- “Outcomes of LASIK Performed Using the Updated Laser Ablation
Algorithm for the Correction of Myopia and Myopic Astigmatism.” Chu
et al.
Featured Educational Events
Friday, April 5
- “Rethinking Dry Eye Disease: A Contemporary Approach to a
Complex Condition” 7:15-9:15 p.m. ET at Davio's Seaport (26 Fan
Pier, Boston) The program will feature the dynamic duo of Laura
Periman, M.D., and Darrell White, M.D., who will discuss MIEBO and
XIIDRA® (lifitegrast ophthalmic solution) 5%.
Saturday, April 6
- “Refractive Redefined: TENEO, the New FDA Approved Excimer
Laser” 3:00-3:50 p.m. ET in the at the Boston Convention &
Exhibit Center (415 Summer Street, Boston; ASCRS Tap Room) Join
George Waring IV, M.D., to learn more about the accuracy,
efficiency and usability advantages of TENEO, the first excimer
laser platform approved in nearly two decades.
- “Innovations in DED and Novel Cataract Surgery Technologies”
6:30-8:00 p.m. ET at the Omni Boston at the Seaport (450 Summer
Street, Boston; Momentum Ballroom, Level 5) Join moderator Eric
Donnenfeld, M.D., along with presenters Marjin Farid, M.D., Ravi
Patel, M.D., and Karl Stonecipher, M.D., to learn more about the
benefits of and differences between MIEBO and XIIDRA, as well as
the benefits of using the new enVista Aspire lens for doctors and
their patients.
Sunday, April 7
- Innovator’s Session Featuring Andrew Stewart, President, Global
Pharmaceuticals and International Consumer 10:00am—11:30am, ASCRS
Main Stage *enVista Envy is pending PMA approval and is not
approved for sale in the United States or its territories
###
Important Safety Information for MIEBO
INDICATION MIEBO® (perfluorohexyloctane ophthalmic
solution) is used to treat the signs and symptoms of dry eye
disease.
IMPORTANT SAFETY INFORMATION
- Patients should remove contact lenses before using MIEBO and
wait for at least 30 minutes before reinserting.
- It is important for patients to use MIEBO exactly as
prescribed.
- It is not known if MIEBO is safe and effective in children
under the age of 18.
- The most common eye side effect seen in studies was blurred
vision (1% to 3 % of patients reported blurred vision and eye
redness).
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
MIEBO.
WHAT IS XIIDRA? XIIDRA (lifitegrast ophthalmic solution)
5% is a prescription eye drop used to treat the signs and symptoms
of dry eye disease.
IMPORTANT SAFETY INFORMATION Do not use XIIDRA if you are
allergic to any of its ingredients. Seek medical care immediately
if you get any symptoms of an allergic reaction.
The most common side effects of XIIDRA include eye irritation,
discomfort or blurred vision when the drops are applied to the
eyes, and an unusual taste sensation.
To help avoid eye injury or contamination of the solution, do
not touch the container tip to your eye or any surface. If you wear
contact lenses, remove them before using XIIDRA and wait for at
least 15 minutes before placing them back in your eyes.
It is not known if XIIDRA is safe and effective in children
under 17 years of age.
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
XIIDRA.
Indications and Important Safety Information for Technolas
Teneo 317 Model 2 System
Indications for Use. The Technolas Teneo 317 Model 2 is
indicated for laser-assisted in situ keratomileusis (LASIK) in: (1)
Patients for the reduction or elimination of myopic astigmatism up
to -10.00 D MRSE, with sphere between -1.00 D and cylinder between
0.00 and -3.00 D; (2) Patients who are 22 years of age or older;
(3) Patients must have a stable refraction in the last 12 months,
as documented by previous clinical recordings, i.e., the spherical
and cylindrical portions of the manifest distance refraction have
not progressed at a rate of more than 0.50 D per year prior to the
baseline examination in the eye(s) to be treated.
WARNING. Danger of injury due to failure to observe the
patient selection criteria! Failure to observe the
contraindications and potential adverse effects may result in
serious permanent patient injury. The usage of the laser system is
limited to a specific field of applications. Observe the
contraindications and potential adverse effects listed in the User
Manual before selecting a patient and starting any
treatment.
Contraindications. Contraindications of the Technolas
Teneo 317 Model 2 include patients: (1) with any type of active
connective tissue disease or autoimmune disease; (2) with signs of
keratoconus, abnormal corneal topography, and degenerations of the
structure of the cornea (including but not limited to pellucid
marginal degeneration); (3) with significant dry eyes (severe Dry
Eye Syndrome). If patients have severely dry eyes, LASIK may
increase the dryness. This may or may not go away. Severe eye
dryness may delay healing of the flap or interfere with the surface
of the eye after surgery. It may result in poor vision after LASIK;
(4) for whom the combination of their baseline corneal thickness
and the planned operative parameters for the LASIK procedure would
result in less than 250µ of residual corneal thickness from corneal
endothelium; (5) with uncontrolled diabetes; (6) with uncontrolled
glaucoma; (7) with active eye infections or active inflammation:
(8) with recent herpes eye infection or problems resulting from
past infections; (9) with known sensitivity to medications used for
standard LASIK surgery.
Potential Risks and Side Effects: (1) Miscreated flap;
(2) Subconjunctival hemorrhage or bleeding; (3) Wrinkles in flap
that may require a flap lift; (4) Corneal erosion/abrasion,
epithelia defect; (5) Elevated IOP; (6) Debris or foreign body
under flap; (7) Epithelial ingrowth under flap; (8) Debilitating
visual symptoms, especially at night; (9) Decreased or fluctuating
visual acuity; (10) Decreased ability to see in low-light
conditions; (11) Light sensitivity; (12) Dry Eye syndrome; (13)
Inadequate treatment result; (14) Regression; (15) Corneal damage;
(16) Posterior vitreous detachment or retinal detachment, floaters
or vascular accidents; (17) Foreign body sensation or pain (initial
postoperative days); also, potentially including chronic eye pain
that is resistant to therapy referred to as neuropathic pain; (18)
Infection/inflammation; (19) CTK (Central Toxic Keratopathy); (20)
Medication intolerance; (21) Ptosis; (22) Cataract; (23) Ocular
penetration; (24) Potential risk of psychological harm.
This is not all you need to know. Please see the User Manual
for a complete list of safety information, including a full list of
contraindications, warnings, precautions and risks.
Caution: Federal (U.S.) law restricts this device to
sale, by or on the order of a physician.
Indications and Important Safety Information for IC-8 Apthera
IOL
INDICATIONS: The IC-8 Apthera IOL is indicated for
unilateral implantation for the visual correction of aphakia and to
create monovision in patients of age 22 or older who have been
diagnosed with bilateral operable cataract, who have up to 1.5 D of
astigmatism in the implanted eye, and who do not have a history of
retinal disease and who are not predisposed to experiencing retinal
disease in the future. The device is intended for primary
implantation in the capsular bag, in the non-dominant eye, after
the fellow eye has already undergone successful implantation
(uncorrected distance visual acuity 20/32 or better and
best-corrected distance visual acuity 20/25 or better) of a
monofocal or monofocal toric IOL that is targeted for emmetropia.
The refractive target for the IC-8 Apthera IOL should be -0.75 D.
The lens mitigates the effects of presbyopia by providing an
extended depth of focus. Compared to an aspheric monofocal or
monofocal toric IOL, the lens provides improved intermediate and
near visual acuity, while maintaining comparable distance visual
acuity.
CONTRAINDICATIONS: (1) Patients with dilated pupil size
less than 7.0 mm. (2) Patients with a history of retinal disease
including but not limited to, high myopia, diabetes, macular
disease, sickle cell disease, retinal tear, retinal detachment,
retinal vein occlusion, ocular tumor, uveitis, and patients who are
predisposed to experiencing retinal disease in the future.
WARNINGS: The lens should not be implanted if appropriate
intraocular support of the lens is not possible. Severe subjective
visual disturbances (e.g., glare, halo, starburst, hazy vision) may
occur after device implantation. There is a possibility that these
visual disturbances may be significant enough that a patient may
request removal of the lens. Contrast sensitivity in eyes implanted
with this lens is significantly reduced when compared to the fellow
eye implanted with a monofocal or monofocal toric IOL. Although
there was no significant reduction in binocular contrast
sensitivity in the IDE clinical study, it is essential that
prospective patients be fully informed of this visual effect in the
implanted eye before giving their consent for unilateral
implantation of the lens. Patients should be informed that they may
need to exercise caution when engaging in activities that require
good vision in dimly lit environments (such as driving at night or
in poor visibility conditions). There is a possibility that visual
symptoms due to reduced contrast sensitivity may be significant
enough that a patient may request removal of the lens. This lens
should not be implanted bilaterally because bilateral implantation
is expected to cause significant reduction in contrast sensitivity
under all lighting conditions. The use of this lens in patients
with corneal astigmatism greater than 1.5 D is not recommended.
Diagnostic tests in patients implanted with the lens may take
longer and require some additional effort from the patient and the
physician to perform. Use of some medical lasers to treat certain
eye conditions may present potential risks of damaging the
FilterRing component of the lens. Removal of the lens may be
necessary prior to retinal or vitreal procedures. Surgeons should
perform a careful benefit-risk assessment based on individual
patient characteristics, weighing all the risks disclosed in the
Directions for Use labeling against the benefit of extended depth
of focus. Nd:YAG laser capsulotomy treatments may be more difficult
to perform and may be less effective in an IC-8 Apthera IOL
implanted eye. Specific training from Bausch & Lomb, Inc. or
its authorized representative related to YAG capsulotomy is
required before a surgeon is authorized to implant the IC-8 Apthera
IOL.
PRECAUTIONS: Prior to surgery, prospective patients
should be informed of the possible risks and benefits associated
with this lens and a Patient Information Brochure should be
provided to the patient. Patients with a predicted postoperative
astigmatism between 1.0 D and 1.5 D may not obtain as great an
amount of improvement in intermediate vision compared to patients
with lower amounts of astigmatism.
CAUTION: Federal law restricts this device to sale by or
on the order of a licensed physician.
ATTENTION: Reference the Directions for Use labeling for
a complete listing of important safety information.
About Bausch + Lomb Bausch + Lomb is dedicated to
protecting and enhancing the gift of sight for millions of people
around the world – from birth through every phase of life. Its
comprehensive portfolio of approximately 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
X, 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. 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.
©2024 Bausch + Lomb. MTB.0113.USA.24
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Media: Caryn Marshall caryn.marshall@bausch.com (908)
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Investor: George Gadkowski george.gadkowski@bausch.com
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Bausch plus Lomb (NYSE:BLCO)
過去 株価チャート
から 12 2024 まで 1 2025
Bausch plus Lomb (NYSE:BLCO)
過去 株価チャート
から 1 2024 まで 1 2025