BHC Bausch Health Companies Inc

13 Poster Presentations Include Results from Second Pivotal Phase 3 Trial of Investigational Treatment NOV03 (Perfluorohexyloctane), as well as Data on XIPERE® (Triamcinolone Acetonide Injectable Suspension) for Suprachoroidal Use

VAUGHAN, ON and LAVAL, QC, April 28, 2022 /PRNewswire/ -- Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), today announced the presentation of 13 scientific poster presentations during the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, which will take place in Denver, Colo., from May 1-4, 2022, and virtually from May 11-12, 2022.

The presentations include results from the second of two pivotal Phase 3 trials of the investigational treatment NOV03 (perfluorohexyloctane), as well as from several studies involving products from the company's consumer health care, pharmaceutical and surgical portfolios, such as XIPERE® (triamcinolone acetonide injectable suspension) for Suprachoroidal Use. There will also be two poster presentations from Bausch + Lomb's ongoing Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR) surveillance study.

"Bausch + Lomb is committed to conducting research to further demonstrate the clinical benefits of our products, to evaluate potential innovations for tomorrow and to monitor epidemiological patterns relevant to ophthalmology," said Joe Gordon, U.S. president, Bausch + Lomb. "At this year's ARVO meeting, we look forward to presenting a number of studies on our pipeline, products and unique ARMOR study so we can provide eye care professionals with valuable clinical insights that can help inform the treatment and care of their patients." 

Following is a complete list of titles and lead authors for each of these posters:

• "Antibiotic Resistance Among Ocular Staphylococcal Pathogens: Longitudinal Trends in the ARMOR Study." Asbell et al.
• "Disinfection Efficacy Testing of a Triple Disinfectant System in an Investigational Multi-Purpose Solution Challenged against the Five Bacterial and Fungal Compendial Organisms." Jennifer Corwin-Buell et al.
• "Efficacy of NOV03 (perfluorohexyloctane) on signs and symptoms of dry eye disease associated with meibomian gland dysfunction: The MOJAVE Study". Sheppard et al.
• "Intraocular Lens Edge Effects on Off-Axis Light Source and Retinal Image Quality." Lau et al.
• "Microbiological Evaluation of an Investigational Multi-Purpose Solution Against Acanthamoeba Trophozoites and Cysts." William Domm et al.
• "National Physician Survey on Clinical Practice Patterns for the Treatment of Noninfectious Uveitis." Cavet et al.
• "Preliminary Antibiotic Resistance Data Among Ocular Bacterial Pathogens in the ARMOR 2021 Study." Sanfilippo et al.
• "Retrospective analysis of the common uses of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension in clinical practice." Deom et al.
• "Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Effect of Disease Characteristics on Clinical Outcomes." Singer et al.
• "Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Integrated Analysis of Two Clinical Trials." Yeh et al.
• "Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Outcomes by Anatomic Subtypes in PEACHTREE." Nguyen et al.
• "Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Visual and Anatomic Outcomes by Age." Henry et al.
• "Ultrasonic Vitrectomy Device-Tissue Interaction Characterization." Higgins et al.

XIPERE^® (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

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.

Bausch + Lomb, a leading global eye health business of Bausch Health Companies, Inc., 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 more than 12,000 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.

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.

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. 

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