Eight Poster Presentations Include Results from 12-Month Safety Extension Trial of Investigational Treatment NOV03 (Perfluorohexyloctane), as well as Data on XIPERE® (Triamcinolone Acetonide Injectable Suspension) for Suprachoroidal Use
Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced the presentation of eight scientific poster presentations during the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, which will take place in New Orleans from April 23-27, 2023.
The presentations include results from the 12-month KALAHARI safety extension study of the investigational treatment NOV03 (perfluorohexyloctane), as well as the results of two studies on surgical intraocular lens pipeline programs. Another presentation will focus on the early adoption of XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use by providers, and two others will feature a data analysis from Bausch + Lomb’s Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR) surveillance study.
“At this year’s ARVO meeting, scientists will present a variety of clinical research on our Bausch + Lomb product portfolio, pipeline programs and the latest results from our unique ARMOR study, which for more than 10 years has tracked antibiotic resistance patterns specific to pathogens that affect the eye,” said Yehia Hashad, M.D., executive vice president, Research & Development and chief medical officer, Bausch + Lomb. “Bausch + Lomb will continue to remain focused on conducting research that will help us develop new products and medicines to address the evolving needs of customers and patients.”
Following is a complete list of titles and lead authors for each of these posters:
- “Antibiotic Resistance Among Ocular Pathogens—an Update from the 2022 ARMOR study.” Sanfilippo et al.
- “Comparative Evaluation of the Attributes of a New Cohesive Ophthalmic Viscosurgical Device.” Hosten et al.
- “Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey.” Chang et al.
- “Evaluation of Color Perception and Contrast Acuity of Novel UV Light-Filtering Material for IOLs as Compared to Yellow-Tinted Blue light Filtering lenses.” Kolesnitchenko et al.
- “Evaluation of Enhanced Monofocal Plus IOLs with Extended Depth of Focus.” Lau et al.
- “Longitudinal Analysis of In Vitro Antibiotic Resistance Among Ocular Staphylococci Collected in the ARMOR study.” Asbell et al.
- “Long‐term Safety and Efficacy of NOV03 (Perfluorohexyloctane) for the Treatment of Patients with Dry Eye Disease associated with Meibomian Gland Dysfunction: The Kalahari Study.” Vittitow et al.
- “Spectroscopic Characterization of Perfluorohexyloctane, an Eye Drop for Dry Eye Disease.” Borchman et al.
Important Safety Information about XIPERE®
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.
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. 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 + Lomb, 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 + 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.
XIPERE® is a trademark of Clearside Biomedical, Inc. used under license.
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