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11/01/2021, Monday

Bausch Health Investor Contact:
Arthur Shannon
arthur.shannon@bauschhealth.com
(514) 865-3855
(877) 281-6642 (toll free)

 

Bausch Health Media Contact:
Lainie Keller
lainie.keller@bauschhealth.com
(908) 927-1198

BAUSCH + LOMB WILL PRESENT SCIENTIFIC DATA AND ANALYSES DURING THE AMERICAN ACADEMY OF OPHTHALMOLOGY AND AMERICAN ACADEMY OF OPTOMETRY ANNUAL MEETINGS

Company to Also Host Promotional Education Events at Both Meetings


LAVAL, Quebec, Nov. 1, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health”), today announced that seven scientific posters involving the company’s products, as well as data from the company's Antibiotic Resistance Monitoring in Ocular MicRoorganisms (ARMOR) surveillance study, will be presented during the annual meetings of the American Academy of Optometry in Boston (Nov. 3-6, 2021) and American Academy of Ophthalmology in New Orleans (Nov. 12-15, 2021). The company will also host several promotional education events.

“Bausch + Lomb is committed to creating opportunities for eye care professionals to learn more about our products, as well as gain valuable insights, such as those we have provided for more than a decade through our unique ARMOR study, the only ongoing surveillance study that evaluates profiles and trends in antibiotic resistance among common ocular bacterial pathogens across the United States,” said Joe Gordon, U.S. president, Bausch + Lomb. “Doing so allows us to educate and inform eye care professionals so they can continue to address the evolving needs of their patients.”

In addition to data from the company’s ARMOR study, the presentations will include analyses on XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use, which received approval by the U.S. Food and Drug Administration in October 2021, and Bausch + Lomb INFUSE® Multifocal contact lenses.*

The full schedule of scientific poster and clinical presentations, as well as the list of promotional education events is as follows:

American Academy of Optometry

Scientific Posters

  • “2020 Results from the Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR) Surveillance Study.” Sanfilippo et al.
  • “Clinical Performance of a Novel Multifocal Contact Lens.” Schafer et al.
  • “In Vitro Antibiotic Resistance among Bacterial Pathogens Sourced from the Cornea in ARMOR.” Sanfilippo et al.

Featured Promotional Education Events
  • Wednesday, Nov. 3
    • “Industry Innovations Lunch & Learn – Practice Pearls & Innovations”
      12:00 to 12:55 p.m. ET at the Westin Boston Seaport District (425 Summer Street, Boston)
      During the program, Art Epstein, O.D., Ben Gaddie, O.D., Kerry Giedd, O.D., and Gina Wesley, O.D., will share practical patient cases using products from across the Bausch + Lomb Consumer Health Care, Vision Care and Pharmaceutical portfolios.
    • “Masters Forum: Crossroads in the Clinical Care of Red Eyes”
      6:30 to 9:00 p.m. ET at Davio’s (26 Fan Pier Boulevard, Boston)
      Art Epstein, O.D., will review many of the most common causes of red and inflamed eyes, differential diagnosis and appropriate treatment options. Attendees can visit https://na.eventscloud.com/website/22747/ to register in advance.
  • Thursday, Nov. 4
    • “Innovations in Inflammation and IOP Control”
      8:00 to 8:45 a.m. ET at the Omni Boston Hotel at the Seaport (450 Summer Street, Boston)
      Program chairs, Michael Chaglasian, O.D., and Mile Brujic, O.D., will review the science and clinical studies behind VYZULTA® (latanoprostene bunod ophthalmic solutions), 0.024% and LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%, as well as their personal perspective on both products.
    • “Innovations in Inflammation and IOP Control”
      6:30 p.m. to 9:00 p.m. ET at Del Frisco’s Double Eagle Steak House (250 Northern Avenue, Suite 200, Boston)
      Paul Karpecki, O.D., and Justin Schweitzer, O.D., will discuss two of the company’s pharmaceutical advancements; LOTEMAX® SM (loteprednol etabonate ophthalmic gel), 0.38%, and VYZULTA® (latanoprostene bunod ophthalmic solutions), 0.024%. Attendees can visit https://na.eventscloud.com/website/31567/ to register in advance.
  • Friday, Nov. 5
    • “Latest AREDS2 10-Year Study Results”
      8:00 to 8:45 a.m. ET at the Omni Boston Hotel at the Seaport (450 Summer Street, Boston)
      During this session, Jeffry Gerson, O.D., will discuss the National Eye Institute’s (NEI) 10-Year Follow-on Study Results of the Age-Related Eye Disease Study 2 (AREDS2) and what the data means for eye care professionals and their patients who have moderate to advance Age-Related Macular Degeneration (AMD).


American Academy of Ophthalmology

Scientific Posters
  • “In Vitro Antibiotic Resistance among Aqueous and Vitreous Humor Bacterial Isolates Collected in the ARMOR Study.” Asbell et al.
  • “Post-Hoc Analysis of Suprachoroidal CLS-TA vs. Rescue Therapies in Macular Edema Associated with Noninfectious Uveitis.” Henry et al.
  • “Evaluation of Visual and Anatomic Temporal Biomarkers in Uveitic Macular Edema.” Grewal et al.
  • “Uveitic Macular Edema: Visual Function and Ocular Anatomy by Severity of Vision Loss.” Reddy et al.

Featured Promotional Education Events
  • Friday, Nov. 12
    • “Latest AREDS2 10-Year Study Results”
      9:00 to 10:00 a.m. CT at the New Orleans Marriott Warehouse Arts District (859 Convention Center Blvd, New Orleans, in the Cypress Ballroom 2)
      During this session, Rishi Singh, M.D., will discuss the NEI’s 10-Year Follow-on Study Results of AREDS2 and what the data means for eye care professionals and their patients who have moderate to advanced AMD.
  • Saturday, Nov. 13
    • “Mastering Astigmatism Management: iTrace & enVista® Toric”
      6:30 to 9:30 p.m. CT at Annunciation Restaurant (1016 Annunciation Street, New Orleans)
      Mitchell Schultz, M.D., and Dee Stephenson, M.D will discuss intraocular lens options, including the enVista® Toric, how surgeons can enhance patient education related to astigmatism and the confidence that can be achieved when combining both the iTrace and enVista® Toric technologies.



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%), cataract (7%), 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.

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.

Please click here for full Prescribing Information.



Important Safety Information for LOTEMAX® SM

Indication
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.



Important Safety Information for VYZULTA®

Indication
VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

IMPORTANT SAFETY INFORMATION

  • Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent
  • Gradual changes to eyelashes, including increased length, increased thickness, and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuation
  • Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). VYZULTA should generally not be used in patients with active intraocular inflammation
  • Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema
  • There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patients
  • Contact lenses should be removed prior to the administration of VYZULTA and may be reinserted 15 minutes after administration
  • Most common ocular adverse reactions with incidence ≥2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%)

Please click here for full Prescribing Information.

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.



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. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

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 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, 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 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.

*Bausch + Lomb INFUSE® Multifocal contact lenses are expected to launch in 2022.


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AREDS and AREDS2 are registered trademarks of the United States Department of Health and Human Services (HHS).
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates.
XIPERE is a trademark of CLEARSIDE BIOMEDICAL used under license.
iTrace is a trademark of Tracey Technologies.
Any other product/brand names are trademarks of the respective owners.
© 2021 Bausch & Lomb Incorporated or its affiliates.

MTB.2404.USA.21

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