Bausch + Lomb at ARVO: 13 Poster Presentations NOV03 XIPERE ARMOR

(PRESS RELEASE)VAUGHAN, ONTARIO, AND LAVAL, QUEBEC — Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”), 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 research benefits to further demonstrate the clinical innovations of our products, to evaluate potentials for tomorrow and to monitor epidemiological patterns relevant to ophthalmology,” said Joe Gordon, US 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.

Important Safety Information about XIPERE

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

Advertisement

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 to bacteria, fungi, and should be used or profitablely 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 here.

Please click here for full Prescribing Information.

Leave a Comment