Survey Reinforces Need for Innovative Therapies, Including Options Administered Through Suprachoroidal Space
VAUGHAN, ON, May 12, 2022 — Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today released findings from a survey designed to gain an understanding of retina specialists’ need for a new treatment option for patients with macular edema associated with noninfectious uveitis and the new drug delivery method in which treatment is administered via the suprachoroidal space. Approximately 85 percent of retina specialists surveyed considered drug delivery via suprachoroidal space as an option for patients with macular edema associated with noninfectious uveitis, approximately 84 percent have high interest in learning more about it and more than nine out of 10 said alternatives are needed to treat patients with this condition. Nearly 70 retina specialists* completed the full survey, which was conducted by Modern Retina®.
Macular edema associated with noninfectious uveitis is the leading cause of vision loss in people with uveitis.1 Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision, and if left untreated, may lead to permanent vision loss.2
“The survey results reinforce what we have heard from customers about the need for innovation for patients with macular edema associated with noninfectious uveitis and underscores the significance behind the availability of XIPERE® (triamcinolone acetonide injectable suspension), which utilizes the suprachoroidal space to provide targeted delivery and compartmentalization of medication,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb. “At Bausch + Lomb, we consistently seek feedback and guidance from eye care professionals to better understand the evolving needs for their patients, and we remain focused on bringing innovative new treatment options to market that address those unmet needs.”
In October 2021, XIPERE® became the first and only treatment to be approved by the U.S. Food and Drug Administration in the United States for delivery via the suprachoroidal space. XIPERE® is also the first therapy indicated specifically for the treatment of macular edema associated with noninfectious uveitis. Suprachoroidal administration is an innovative technique for delivering ocular therapies that may facilitate more targeted delivery of therapeutic agents to the retina and choroid.
“The suprachoroidal space is often considered the next frontier in eye health, and with the recent launch of XIPERE®, eye care professionals now have a new and innovative treatment option for patients with macular edema associated with uveitis,” said Steven Yeh, M.D., professor of Ophthalmology and director of Retinal Disease and Uveitis, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center and principal investigator for the XIPERE® Phase 3 trials.
Additionally, more than half of retina specialists surveyed said that training is the most important factor to integrate suprachoroidal administration into a practice. Because the suprachoroidal administration technique for XIPERE® is unlike traditional intraocular administration, Bausch + Lomb offers free training on how to inject patients with this new medicine. Physicians interested in attending a XIPERE® training session can register at https://www.xipere.com/hcp/xipere-training.
For more information on XIPERE®, visit www.xipere.com.
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 Modern Retina®
Modern Retina® is the leading multimedia resource for retinal physicians. As a complementary resource to Ophthalmology Times®, Modern Retina® empowers relevant clinical and surgical connections through balanced and immersive content. Topics of focus include age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), and uveitis. Modern Retina® is a brand of MJH Life Sciences™, the largest privately held, independent, full-service medical media company in North America, dedicated to delivering trusted health care news across multiple channels.
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 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.
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. 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.
References
- Massa, H., Pipis, S. Y., Adewoyin, T., Vergados, A., Patra, S., & Panos, G. D. (2019). Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. Clinical ophthalmology (Auckland, N.Z.), 13, 1761–1777. https://doi.org/10.2147/OPTH.S180580.
- American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-health/diseases/what-is-macular-edema . Accessed August 20, 2021.
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates, except XIPERE®, suprachoroidal space (SCS®) and SCS Microinjector® is a trademark of Clearside Biomedical, Inc. used under license. Any other product/brand names are trademarks of the respective owners.
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SOURCE Bausch + Lomb Corporation
