About TRIESENCE®

Proven Efficacy in the Treatment of Uveitis

Studies reported an improvement in visual acuity and a reduction in intraocular inflammation by intravitreal injection of 25 mg of TRIESENCE in a case study of non-infectious uveitis due to sympathetic ophthalmia.3

Proven to Improve Visualization

Masked reader assessments of visualization of the posterior segment structures (PSS).2

  • Mean visualization score was 3.7 post-instillation vs 0.5 pre-instillation (P<0.0001)

  • Post-instillation 83.3% of PSS were assessed as clearly delineated (score of 4) vs 0% pre-instillation

  • Pre-instillation 60.0% of PSS were assessed as not visible (score of 0); post-instillation 1.7% were assessed as not visible

Study Description

A phase Ill, observer-masked study enrolled 60 patients undergoing pars plana vitrectomy. TRIESENCE® Suspension (up to 4 mg) was administered to enhance visualization of vitreous and membranes. Video recordings captured visualization pre- and post-instillation. An independent, masked reader evaluated the videos using a scale from 0 (not visible) to 4 (clearly delineated). Surgeons used a scale ranging from "strongly disagree to "strongly agree" to assess whether TRIESENCE® Suspension improved visualization.2

Preservative-Free4

TRIESENCE is preservative-free, which reduces the potential for the preservative to cause ocular inflammation.

Safe for the Operating Room

TRIESENCE is terminally sterilized and comes in a vial with a sterile exterior, making it ideal for use in the operating room.1

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

TRIESENCE® Suspension is indicated for:

  • Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
  • Visualization during vitrectomy.
Contraindications
  • TRIESENCE® Suspension is contraindicated in patients with systemic fungal infections.
  • TRIESENCE® Suspension is also contraindicated in patients with hypersensitivity to corticosteroids or any component of TRIESENCE® Suspension. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.
Warnings and Precautions
  • TRIESENCE® is a suspension; it 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.
Adverse Reactions
  • Based on a review of the available literature, the most commonly reported adverse events following ocular administration of triamcinolone acetonide were elevated intraocular pressure and cataract progression. These events have been reported to occur in 20-60% of patients.
  • Less common reactions occurring in up to 2% of patients include: endophthalmitis (infectious and non-infectious), hypopyon, injection site reactions (described as blurring and transient discomfort), glaucoma, vitreous floaters, detachment of retinal pigment epithelium, optic disc vascular disorder, eye inflammation, conjunctival hemorrhage and visual acuity reduced. Cases of exophthalmos have also been reported.
Drug Interactions
  • Anticoagulant Agents –Corticosteroids may enhance or diminish the anticoagulant effect of anticoagulant agents. Coagulation indices should be monitored.
  • Antidiabetic Agents –Corticosteroids may increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required.
  • CYP 3A4 Inducers and Inhibitors –CYP 3A4 inducers and inhibitors may respectively increase or decrease clearance of corticosteroids, necessitating dose adjustment.
  • NSAIDs –Concomitant use of NSAIDS, including aspirin and salicylates, with a corticosteroid may increase the risk of GI side effects.

For additional Important Safety Information about TRIESENCE® Suspension, please see the accompanying full Prescribing Information.


References: 1. TRIESENCE Prescribing information. Harrow IP, LLC; 2023. 2. Dyer, David Md; Callanan, David Md; Clinical Evaluation Of The Safety And Efficacy Of Preservative-Free Triamcinolone (Triesence® [Triamcinolone Acetonide Injectable Suspension] 40 Mg/Ml) For Visualization During Pars Plana Vitrectomy. Retina 29(1):P 38-45, January 2009. | Doi: 10.1097/Iae.0b013e318188c6e2. 3. Thorne JE, Sugar EA, Holbrook JT, Burke AE, Altaweel MM, Vitale AT, Acharya NR, Kempen JH, Jabs DA; Multicenter Uveitis Steroid Treatment Trial Research Group. Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial. Ophthalmology. 2019 Feb;126(2):283-295. doi: 10.1016/j.ophtha.2018.08.021. Epub 2018 Sep 27. PMID: 30269924; PMCID: PMC6348060. 4. Maia M, Farah ME, Belfort RN, et alEffects of intravitreal triamcinolone acetonide injection with and without preservativeBritish Journal of Ophthalmology 2007;91:1122-1124. 

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE:

TRIESENCE® Suspension is indicated for:

  • Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
  • Visualization during vitrectomy.
Contraindications
  • TRIESENCE® Suspension is contraindicated in patients with systemic fungal infections.
  • TRIESENCE® Suspension is also contraindicated in patients with hypersensitivity to corticosteroids or any component of TRIESENCE® Suspension. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.
Warnings and Precautions
  • TRIESENCE® is a suspension; it 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.
Adverse Reactions
  • Based on a review of the available literature, the most commonly reported adverse events following ocular administration of triamcinolone acetonide were elevated intraocular pressure and cataract progression. These events have been reported to occur in 20-60% of patients.
  • Less common reactions occurring in up to 2% of patients include: endophthalmitis (infectious and non-infectious), hypopyon, injection site reactions (described as blurring and transient discomfort), glaucoma, vitreous floaters, detachment of retinal pigment epithelium, optic disc vascular disorder, eye inflammation, conjunctival hemorrhage and visual acuity reduced. Cases of exophthalmos have also been reported.
Drug Interactions
  • Anticoagulant Agents –Corticosteroids may enhance or diminish the anticoagulant effect of anticoagulant agents. Coagulation indices should be monitored.
  • Antidiabetic Agents –Corticosteroids may increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required.
  • CYP 3A4 Inducers and Inhibitors –CYP 3A4 inducers and inhibitors may respectively increase or decrease clearance of corticosteroids, necessitating dose adjustment.
  • NSAIDs –Concomitant use of NSAIDS, including aspirin and salicylates, with a corticosteroid may increase the risk of GI side effects.

For additional Important Safety Information about TRIESENCE® Suspension, please see the accompanying full Prescribing Information.