Harrow Provides TRIESENCE® Relaunch Update
Successful Manufacture of TRIESENCE PPQ Batch Leads to Scheduling of Remaining Process Qualification Steps, Initial Inventory Build, and Pre-Commercial Activities

TRIESENCE (Photo: Business Wire)
TRIESENCE has been on the FDA Drug Shortage List for over five years with all TRIESENCE inventories having been depleted in the U.S. market for over two years. Harrow remains committed to making TRIESENCE available to
Mark L. Baum, Chairman and Chief Executive Officer of Harrow, commented, “We are delighted to confirm the successful completion of the first of three TRIESENCE PPQ batches. This milestone resulted from the commitment of teams working in
“TRIESENCE, a trusted and high-utility solution for ophthalmologists and retina specialists, has not been easily or economically replaceable during this lengthy shortage and out‑of-stock period. Concurrent with our technical team completing the validation of the TRIESENCE qualification process, Harrow’s commercial leadership is initiating pre‑commercialization activities, including discussions with strategic accounts to pre‑order the expected initial inventory of TRIESENCE.”
If you are an ophthalmologist, retina specialist, or an institution interested in securing a quantity allocation of TRIESENCE, please complete the following form for an immediate supply review.
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/20240620854415/en/
Investors
Jamie Webb
Director of Communications and Investor Relations
jwebb@harrowinc.com
615-733-4737
Media
Deb Holliday
Holliday Communications, Inc.
deb@hollidaycommunications.net
412-877-4519
Source: Harrow, Inc.