Harrow Announces Transitional Pass-Through Reimbursement Status for TRIESENCE® (Triamcinolone Acetonide Injectable Suspension) 40 mg/mL
Beginning April 1, 2025, and for the three years thereafter, TRIESENCE will be eligible for separate reimbursement outside of the surgical bundled payment in both the Ambulatory Surgery Center (ASC) and Hospital Outpatient Department (HOPD) settings of care. CMS previously approved the issuance of a permanent, product-specific J‑Code (J3300) for TRIESENCE, facilitating reimbursement and access in eyecare professionals’ offices. With this new CMS approval, TRIESENCE becomes the only preservative-free synthetic corticosteroid with separate reimbursement in all traditional settings of care – the eyecare professional’s office, the ASC, and the HOPD. CMS will now separately reimburse TRIESENCE at the Average Sales Price (ASP) plus
“We sincerely appreciate CMS’s approval of pass-through reimbursement status for TRIESENCE, recognizing its unique value to ophthalmic care,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “Following Harrow’s investment in the restoration of the TRIESENCE supply chain, this decision expands patient access to TRIESENCE, allowing all ophthalmologists, including retina specialists, to return confidently to using an FDA-approved, preservative-free treatment option in lieu of the more dangerous, off-label options they had been forced to use while TRIESENCE was unavailable. This news, which allows for the reimbursement of TRIESENCE in a critical setting of care, increases access to all Medicare beneficiaries and should improve surgical outcomes and patient safety across the country.”
Billing and Ordering TRIESENCE
TRIESENCE (J3300 Injection, triamcinolone acetonide, preservative-free, 1 mg) is a single-use vial of 40 milligrams or 40 units based on the HCPCS descriptor.
Healthcare providers may order TRIESENCE directly through major pharmaceutical specialty distributors, including Besse Medical/Cencora, McKesson/McKesson Medical-Surgical, and Cardinal Health/Cardinal Specialty/Metro Medical. TRIESENCE is currently listed under both NDC 00078-0897-78 and NDC 82667-0800-01. Additional information about TRIESENCE can be found at TRIESENCEHCP.com.
About Harrow
Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making its portfolio of pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow, please visit harrow.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the
About TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL:
HIGHLIGHTS OF TRIESENCE PRESCRIBING INFORMATION
INDICATIONS AND USAGE
TRIESENCE suspension is a synthetic corticosteroid indicated for:
- Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
- Visualization during vitrectomy.
DOSAGE AND ADMINISTRATION
- Initial recommended dose for all indications except visualization: 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment.
- Recommended dose for visualization: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally.
DOSAGE FORMS AND STRENGTHS
Single use 1 mL vial containing 40 mg/mL of triamcinolone acetonide suspension.
CONTRAINDICATIONS
- Patients with systemic fungal infections.
- Hypersensitivity to triamcinolone or any component of this product.
WARNINGS AND PRECAUTIONS
- TRIESENCE suspension should not be administered intravenously.
- Ophthalmic effects: May include cataracts, infections, and glaucoma. Monitor intraocular pressure.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and hyperglycemia: Monitor patients for these conditions and taper doses gradually.
- Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection.
- Elevated blood pressure, salt and water retention, and hypokalemia: Monitor blood pressure and sodium, potassium serum levels.
- GI perforation: Increased risk in patients with certain GI disorders.
- Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.
- Decreases in bone density: Monitor bone density in patients receiving long-term corticosteroid therapy.
- Live or live attenuated vaccines: Do not administer to patients receiving immunosuppressive doses of corticosteroids.
- Negative effects on growth and development: Monitor pediatric patients on long-term corticosteroid therapy.
- Use in pregnancy: Fetal harm can occur with first trimester use.
- Weight gain: May cause increased appetite.
DRUG INTERACTIONS
- Anticoagulant agents: May enhance or diminish anticoagulant effects. Monitor coagulation indices.
- Antidiabetic agents: May increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required.
- CYP 3A4 inducers and inhibitors: May respectively increase or decrease clearance of corticosteroids necessitating dose adjustment.
- Non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and salicylates: Increased risk of gastrointestinal side effects.
For complete product information about TRIESENCE, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3f045347-3e5e-4bbd-90f8-6c3100985ca5
View source version on businesswire.com: https://www.businesswire.com/news/home/20250324980329/en/
Investors:
Jamie Webb, Director of Communications and Investor Relations
Harrow, Inc.
jwebb@harrowinc.com
615-733-4737
Media:
Silvana Guerci-Lena
Powers & Company
silvana@powers-co.com
508-808-8993
Source: Harrow, Inc.