Harrow announced the completion of the transfer to Harrow of the New Drug Application (NDA) for TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL, a synthetic corticosteroid indicated for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids as well as visualization during vitrectomy.
In January of 2023, Harrow agreed to acquire the U.S. commercial rights to TRIESENCE. Aside from the transfer of the TRIESENCE NDA ahead of the date previously agreed to, all other acquisition terms remain unchanged.
“While we continue to diligently work with our contract manufacturing partner, making solid progress manufacturing commercial batches of TRIESENCE, the mutual agreement to an early transfer of the TRIESENCE NDA was an important step in advancing our strategy to re-launch the product under the Harrow umbrella,” said Mark L. Baum, CEO of Harrow. “With this crucial process completed, our team has begun to implement our market access, marketing, inventory management, national sales detailing, and other brand-leveraging strategies so that we will be ready to re-launch TRIESENCE in the U.S. once we have achieved a successful inventory build, which we are currently working diligently towards. We remain excited to be able to provide TRIESENCE to the U.S. ophthalmic community soon.”
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.