Bausch + Lomb Receives CPT Category 1 Code for XIPERE® (Triamcinolone Acetonide Injectable Suspension) From the American Medical Association

VAUGHAN, Ontario, Nov. 3, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, announced today the American Medical Association (AMA) has confirmed assignment of the Category 1 Current Procedural Terminology (CPT) code for XIPERE. The AMA has granted the CPT code 67516 with support from the American Academy of Ophthalmology (AAO) and the American Society of Retina Specialists (ASRS).

“The category 1 code will help facilitate better access and adoption of XIPERE and its unique suprachoroidal injection method, which enables targeted delivery of the medication,” Andrew Stewart, president, Global Pharmaceuticals and International Consumer, Bausch + Lomb. “We greatly appreciate the support and guidance AAO and ASRS provided throughout this process.”

The new CPT Category 1 code and their descriptors covering the XIPERE procedure will be included in a future edition of the CPT Codebook and will be effective on Jan. 1, 2024. The XIPERE J-code J3299 became effective in July 2022.

XIPERE is the first and only therapy available in the United States that utilizes the suprachoroidal space to treat patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis, a form of eye inflammation.1,2 It became commercially available in March 2022. 

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About XIPERE

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.

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 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.





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. 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

  1. 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.
  2. XIPERE® [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.; 2021.

© 2023 Bausch + Lomb.

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