Harrow Relaunches TRIESENCE®
In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We are very excited to have brought TRIESENCE back to the U.S. market, providing ophthalmologists access to a trusted FDA-approved product that has benefited millions of Americans. Accomplishing this required rebuilding the entire TRIESENCE supply chain and involved a global collaboration between Harrow and technical experts from our partners around the world. We are grateful for this team’s dedication and commitment, without which we would not have achieved this success.”
In response to Harrow’s relaunch of TRIESENCE, Dr. Rishi Singh, MD, an ophthalmologist and vitreoretinal surgeon of Cleveland Clinic Florida, remarked, “An FDA-approved, preservative-free corticosteroid is critical for office-based and surgical procedures. TRIESENCE is a pharmaceutically elegant injectable suspension that appears as a white backdrop against the back of the retina, enabling a higher degree of visibility of the vitreous and pathologic membranes during vitrectomy. It has long been a trusted, indispensable resource, and its absence has left many ophthalmologists and retina specialists without a reliable alternative.
“The relaunch of TRIESENCE, following more than five years on the FDA Drug Shortage List and two years of inventory depletion, brings much-needed relief for both eyecare professionals and their patients. During its absence, many were forced to adapt with less ideal, off-label solutions such as modifying preserved Kenalog-40, which posed potential risks. Now that TRIESENCE is back, we can confidently provide safer, more effective treatment, improving surgical outcomes and patient care.”
Dr. John W. Kitchens, MD, an ophthalmologist and vitreoretinal surgeon with Retina Associates of
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 Medical-Surgical, and Cardinal Health. Initial supplies of TRIESENCE will be listed under both NDC 00078-0897-78 and NDC 82667-800-01.
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 prescription and non-prescription 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/20241003460620/en/
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Director of Communications and Investor Relations
jwebb@harrowinc.com
615-733-4737
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Holliday Communications, Inc.
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412-877-4519
Source: Harrow, Inc.