AMA Assigned XIPERE® a Category I Permanent CPT Code (67516) — Effective January 1, 2024

DESCRIPTION: Suprachoroidal injection of a pharmacologic agent; does not include supply of medication

Permanent XIPERE J-CODE (J3299)

DESCRIPTION: Injection, Triamcinolone Acetonide (XIPERE®), 1 mg

Access Resources

XIPERE® Full Prescribing Information
XIPERE® Full Prescribing Information Download
FDA Approval Letter
FDA Approval Letter Download
Letter of Medical Necessity
Letter of Medical Necessity Download
See more data from XIPERE®
Clincial Trials

Ordering, Billing, and Coding Resources

FOA Program Enrollment Form pdf
FOA Program Enrollment Form Download
Coding + Billing Checklist pdg
Coding and Billing Checklist Download
Sample Claim Form pdf
Sample Claim Forms Download
Billing and Coding Guide pdf
Billing & Coding Guide Download

Injection Training Resources

Dr. Chang
Introduction to XIPERE®

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Dr. Chang
XIPERE® Injection Technique

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Injection
Training Video

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Instructions
for Use

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Training Resources

Injection Training Video
Injection Training Video Download
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Instructions for Use pdf
Instructions for Use Download
Injection Training FAQs pdf
Injection Training FAQs Download

Patient Resources

FOA & Savings Patient Pamphlet pdf
Savings and FOA Pamphlet Download
Patient Brochure PDF
Patient Brochure Download

XIPERE® Patient
Profile Series

Review a range of patient profiles and see why XIPERE® may be an appropriate choice.

Patient Profile: Paul Download
Patient Profile: Naomi Download

Answers to common questions about XIPERE® and the SCS Microinjector®

How can I use XIPERE® to help my patients?

XIPERE® treats macular edema (ME) associated with all anatomical locations of uveitis.1

XIPERE® is the only treatment approved to deliver medicine via the suprachoroidal space and the first and only uveitic macular edema treatment to demonstrate clinical efficacy with a BCVA primary endpoint.1

The primary endpoint was the number of patients who achieved significant BCVA improvements of 15 or more letters from baseline at 24 weeks.

XIPERE® is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, for example1:

  • active epithelial herpes simplex keratitis (dendritic keratitis)
  • vaccinia
  • varicella
  • mycobacterial infections
  • fungal diseases

XIPERE® is also contraindicated in patients with known hypersensitivity to triamcinolone acetonide or any other components of this product.

The most common ocular adverse reactions ranged from nonacute elevated IOP (patients treated with XIPERE® and patients in the control group were equivalent at a rate of 14%, n=13/96 and n=9/64 respectively) to blurred vision at 2% of patients treated with XIPERE® with zero reports in the control group (n=2/96 and n=0/64 respectively).

Please see full adverse events profile under Safety & Tolerability section.

The SCS Microinjector® is composed of a syringe and two 30-gauge hollow microneedles of 900 μm and 1100 μm in free length.1

This suprachoroidal injection is designed to be carried out perpendicular to the sclera under local anesthesia. Once the microneedle penetrates the sclera and reaches the SCS®, the open bevel of the needle releases the drug which spreads to the back of the eye, targeting the tissues of interest.1,2

Yes. Training is highly recommended for the administering specialist.

You can schedule a training session by sharing your name and email address and a local representative will be in touch to arrange.

Have more questions?

Connect with a representative to learn more about XIPERE®.

Reach Out

XIPERE® Savings Program Eligibility Criteria/Terms and Conditions:

By using the XIPERE® Savings Program, you confirm that you understand and agree to comply with the following terms and conditions of this offer:

  • Reimbursement limitations apply. Patient is responsible for all additional costs and expenses after reimbursement limits are reached, including additional copayment and coinsurance amounts.
  • This offer is only valid for eligible patients with commercial insurance and coverage.
  • This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs.
  • The XIPERE® Savings Program will only apply to patient out-of-pocket costs for the product and injection administration of XIPERE®. This offer will not be applied towards ancillary services.
  • You agree not to seek reimbursement for all or any part of the benefit received through this offer and are responsible for making any required reports of your use of this offer to any insurer or other third party who pays any part of the prescription filled.
  • This offer is good only in the United States of America (including the District of Columbia, Puerto Rico, Guam, and the U.S. Virgin Islands). Residents of the states of California, Massachusetts, Minnesota and Rhode Island are eligible only for copay assistance for out-of-pocket costs for the XIPERE® product and are not eligible for copay assistance for any of the cost of injection administration of XIPERE®.
  • This offer is not valid for any person who is 65 years of age or older without commercial insurance and coverage for the product. You must be 18 years of age or older to redeem this offer.
  • This offer is good for use only with the products identified herein. No other purchase is necessary.
  • This offer is not valid where prohibited, taxed, or otherwise restricted.
  • This offer cannot be redeemed at government-subsidized clinics.
  • This offer is not health insurance.
  • The selling, purchasing, trading, or counterfeiting of this coupon is prohibited by law. Void if reproduced.
  • This program is not valid with other offers. Offer has no cash value. No cash back.
  • Bausch + Lomb reserves the right to rescind, revoke, terminate, or amend this program at any time, without notice.
  • Program terms will expire at the end of each calendar year.

If you are not eligible for the XIPERE® Savings Program, there may be other options for co-pay assistance. Call 866-272-8838 to speak to a XIPERE® Savings Program representative to learn more.

 

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information.

AMA=American Medical Association, BCVA=best-corrected visual acuity, CPT=current procedural terminology, IOP=intraocular pressure.

References

  1. XIPERE® [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.
  2. Yeh S, Khurana RN, Shah M, et al. Efficacy and safety of suprachoroidal CLS-TA for macular edema secondary to noninfectious uveitis: phase 3 randomized trial. Ophthalmology. 2020;127(7):948-955.
  3. Rai Udo J, Young SA, Thrimawithana TR, et al. The suprachoroidal pathway: a new drug delivery route to the back of the eye. Drug Discov Today. 2015;20(4):491-495.

Indication

Important Safety Information

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.

Patients should be monitored following injection for elevated intraocular pressure. See Dosage and Administration instructions in full Prescribing Information.