Bausch + Lomb Announces Scientific Data on XIPERE® (Triamcinolone Acetonide Injectable Suspension) to be Presented During the American Society of Retina Specialists Annual Scientific Meeting
Bausch + Lomb Corporation (NYSE/TSX: BLCO) has announced that five presentations concerning the XIPERE® pivotal Phase 3 trial will be made at the American Society of Retina Specialists (ASRS) meeting from July 13-16, 2022, in New York. These presentations include a post-hoc analysis evaluating outcomes for macular edema linked to chronic uveitis. XIPERE® is the first treatment approved in the U.S. for delivery through the suprachoroidal space, demonstrating clinical efficacy in improving visual acuity.
- Five presentations will provide detailed findings from the XIPERE® Phase 3 trial, enhancing visibility among retina specialists.
- XIPERE® is the first and only treatment approved for delivery via the suprachoroidal space, indicating a unique market position.
- XIPERE® demonstrates clinical efficacy in improving Best Corrected Visual Acuity (BCVA), which is a key metric in ophthalmic treatments.
- No mention of anticipated challenges or risks related to XIPERE® in the market.
Five Presentations Will Highlight Findings from the XIPERE® Pivotal Phase 3 Program
VAUGHAN, ON, July 6, 2022 /PRNewswire/ -- 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 that five presentations highlighting data from the XIPERE® (triamcinolone acetonide injectable suspension) pivotal Phase 3 program will be presented at the American Society of Retina Specialists (ASRS) 40th annual scientific meeting, which will take place in New York from July 13-16, 2022. The presentations will include a new post-hoc analysis of the pivotal Phase 3 trial (PEACHTREE) evaluating outcomes following treatment with XIPERE® in patients with macular edema associated with chronic uveitis.
"At this year's ASRS annual meeting, we look forward to sharing these data with retina specialists on XIPERE®, which we launched commercially in March," said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb. "We have received great interest in XIPERE® from the eye care professional community since then, and we appreciate the opportunity that the ASRS meeting affords us to continue to provide valuable clinical insights on the product, as well as on its novel use of the suprachoroidal space to help treat patients with macular edema associated with uveitis."
Following is a complete list of titles and lead authors for each of the presentations:
- Ghoraba et al. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with uveitis: Outcomes by anatomic subtypes in PEACHTREE.
- Henry et al. Efficacy of suprachoroidal triamcinolone acetonide injectable suspension in the treatment of macular edema in patients with chronic uveitis.
- Pan et al. Suprachoroidal use of triamcinolone acetonide: Post hoc analysis of PEACHTREE to evaluate elevations in intraocular pressure.
- Uchiyama et al. Suprachoroidal triamcinolone acetonide injectable suspension for uveitic macular edema: Outcomes in PEACHTREE by baseline disease characteristics.
- Yeh et al. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with uveitis: Integrated analysis of two clinical trials.
XIPERE® is a triamcinolone acetonide injectable suspension for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation. XIPERE® is the first and only treatment to be approved in the United States for delivery via the suprachoroidal space and the first and only uveitic macular edema treatment to demonstrate clinical efficacy with a BCVA (Best Corrected Visual Acuity) primary endpoint. XIPERE® is administered via the suprachoroidal space using the SCS Microinjector®. The SCS Microinjector® offers unprecedented access to the back of the eye where sight-threatening disease often occurs and provides targeted delivery to potentially improve efficacy and compartmentalization of medication.
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 in2% 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 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.
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®, SCS® and SCS Microinjector® are trademarks of Clearside Biomedical, Inc. used under license.
Any other product/brand names are trademarks of the respective owners.
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