Presentations Will Feature Studies
Evaluating MIEBO™ (Perfluorohexyloctane Ophthalmic Solution), IC-8®
Apthera™ IOL and ARMOR Surveillance Study Data
Company Will Host Six Educational
Events
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye
health company dedicated to helping people see better to live
better, today announced three podium presentations and seven poster
presentations during the American Academy of Ophthalmology (AAO)
annual meeting, which will take place in San Francisco Nov. 3-6,
2023.
Three podium presentations will feature an evaluation of the use
of IC-8 Apthera intraocular lens (IOL) in patients with complex
cases as well as an analysis of data on the unique Antibiotic
Resistance Monitoring in Ocular MicRooganisms (ARMOR) surveillance
study, which evaluates trends in antibiotic resistance among common
ocular bacterial pathogens across the United States. The poster
presentations will also highlight ARMOR study results, as well as
the results of studies evaluating IC-8 Apthera IOL, XIPERE®
(triamcinolone acetonide injectable suspension) 40 mg/mL and newly
launched MIEBO.
Six company-sponsored educational events will focus on these and
other Bausch + Lomb products, including the new enVista® Aspire
IOL.
The Bausch + Lomb schedule at AAO:
Podium Presentations
- “ARMOR Against Antibiotic Resistance: When Treatment Can't
Wait.” Asbell et al.
- “Evaluation of Visual Outcomes in Patients with Complex Corneas
Implanted with a Small Aperture IOL.” Ming et al.
- “Small-Aperture Optics and Surgery to Achieve Pinhole Effect:
Instructional Course.” Narang et al.
Poster Presentations
- “A Novel Small Aperture IOL Provides Monovision with a
Continuous Range of Vision.” Yeu et al.
- “Experience with Triamcinolone Acetonide Suprachoroidal
Injection for Uveitic Macular Edema: A Physician Survey.” Singer et
al.
- “In Vitro Antibiotic Resistance Among Intraocular Bacterial
Pathogens: Results from the ARMOR Study.” Asbell et al.
- “NOV03 Eye Drop for Dry Eye Disease: Safety and Efficacy Across
Development Studies.” Sheppard et al.
- “Prospective Study of Small Aperture IOL Implantation in Eyes
with Previous Refractive Procedures.” Ang et al.
- “Retinal Visualization in a Small Aperture IOL Treated Eye.”
Blecher et al.
- “Visual Outcomes with a Small-Aperture IOL in Post Radial
Keratotomy Patients.” Sudhinder et al.
Featured Educational Events
Friday, November 3
- “The Anti-Evaporative Piece of the Dry Eye Rx Eye Drop Puzzle”
7:30 p.m. PT at Morton’s Steakhouse (400 Post Street, San
Francisco) Join Sheri Rowen, M.D., and Darrell White, M.D., to
learn more about MIEBO, the first and only prescription eye drop
that directly addresses tear evaporation. Register in advance.
Saturday, November 4
- “Industry Showcase: MIEBO – A Different Approach to Treating
the Signs and Symptoms of Dry Eye Disease” 12:10-12:40 p.m. PT at
Moscone Convention Center (747 Howard Street, San Francisco; North
Hall, booth #5302) Excessive tear evaporation is a leading driver
of DED and triggers a vicious cycle of symptoms.1,2,3 Preeya K.
Gupta, M.D. and Kenneth A. Beckman, M.D., will lead a conversation
on how to directly target tear evaporation with MIEBO prescription
eye drops.
- “Industry Showcase TED Talk: Complex Cases Made Simple by
Unleashing the Power of Dual-Linear Chop” 2:00-2:18 p.m. PT at
Moscone Convention Center (747 Howard Street, San Francisco; North
Hall, booth #5302) Reena A. Garg, M.D., and Paul Petelin, Jr.,
M.D., will discuss the power of independent control of vacuum and
ultrasound simplifying traditionally complex cases with dual-linear
technology.
- “Innovations in Evaporative DED & Novel Cataract Surgery
Technologies” 6:00-8:00 p.m. PT at the Hibernia San Francisco (1
Jones Street, San Francisco) An expert panel, moderated by Eric D.
Donnenfeld, M.D., and featuring Mark Lobanoff, M.D., Marguerite
McDonald, M.D., and Karl G. Stonecipher, M.D., will review and
discuss Bausch + Lomb’s MIEBO prescription eye drops, Apthera™
small aperature IOL and Eyetelligence™ platform. Register in
advance.
Sunday, November 5
- “Industry Showcase: Elevate the Everyday – Discover Bausch +
Lomb’s New IOL” 12:10 – 12:40 p.m. PT at Moscone Convention Center
(747 Howard Street, San Francisco; North Hall, booth #5302) Andrew
Jones and George Lau, O.D., will discuss the new enVista® Aspire
monofocal and toric intraocular lenses with Intermediate Optimized
optics, which combines novel optics, which are designed for a
broader depth of focus, with the proven benefits of the Bausch +
Lomb enVista platform.
- “Industry Showcase TED Talk: The Science of MIEBO
(Perfluorohexyloctane Ophthalmic Solution)” 1:00-1:18 p.m. PT at
Moscone Convention Center (747 Howard Street, San Francisco; North
Hall, booth #5302) Jason Vittitow, Ph.D., will review the science
behind MIEBO, the first and only prescription eye drop that
directly addresses tear evaporation.
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).
Click here for full Prescribing Information for
MIEBO.
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.
Important Safety Information about XIPERE
INDICATION XIPERE (triamcinolone acetonide injectable
suspension) for suprachoroidal use is a corticosteroid indicated
for the treatment of macular edema associated with uveitis.
IMPORTANT SAFETY INFORMATION
Patients should be monitored following injection for elevated
intraocular pressure. See Dosage and Administration instructions in
full Prescribing Information.
- XIPERE is contraindicated in patients with active or
suspected ocular or periocular infections including most viral
diseases of the cornea and conjunctiva, including active epithelial
herpes simplex keratitis (dendritic keratitis), vaccinia,
varicella, mycobacterial infections, and fungal diseases.
- XIPERE is contraindicated in patients with known
hypersensitivity to triamcinolone acetonide or any other
components of this product.
- Use of corticosteroids may produce cataracts, increased
intraocular pressure, and glaucoma. Use of corticosteroids may
enhance the establishment of secondary ocular infections due to
bacteria, fungi, or viruses, and should be used cautiously in
patients with a history of ocular herpes simplex.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression,
Cushing’s syndrome, and hyperglycemia can occur following
administration of a corticosteroid. Monitor patients for these
conditions with chronic use.
- In controlled studies, the most common ocular adverse reactions
were increased ocular pressure, non-acute (14%), eye pain,
non-acute (12%), cataract (7%), increased intraocular pressure,
acute (6%), vitreous detachment (5%), injection site pain (4%),
conjunctival hemorrhage (4%), visual acuity reduced (4%), dry eye
(3%), eye pain, acute (3%), photophobia (3%), and vitreous floaters
(3%), and in 2% of patients: uveitis, conjunctival hyperaemia,
punctate keratitis, conjunctival oedema, meibomianitis, anterior
capsule contraction, chalazion, eye irritation, eye pruritus,
eyelid ptosis, photopsia, and vision blurred.
The most common non-ocular adverse event was headache (5%).
Corticosteroids should be used during pregnancy or nursing only
if the potential benefit justifies the potential risk to the fetus
or nursing infant.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb
at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit
www.fda.gov/medwatch.
Please click here for full Prescribing Information.
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. 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.
References
- Craig JP, Nelson JD, Azar DT, et al. TFOS DEWS II report
executive summary. Ocul Surf. 2017;15(4):802-812.
doi:10.1016/j.jtos.2017.08.003.
- Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD.
Distribution of aqueous-deficient and evaporative dry eye in a
clinic-based patient cohort: a retrospective study. Cornea.
2012;31(5):472-478. doi:10.1097/ICO.0b013e318225415a.
- Pflugfelder SC, de Paiva CS. The pathophysiology of dry eye
disease: what we know and future directions for research.
Ophthalmology. 2017;124(11S):S4-S13.
doi:10.1016/j.ophtha.2017.07.010.
© 2023 Bausch + Lomb. MTB.0310.USA.23
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Media Contact: Kristy Marks kristy.marks@bausch.com (908)
927-0683 Investor Contact: George Gadkowski
george.gadkowski@bausch.com (877) 354-3705 (toll free) (908)
927-0735
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