Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TRIESENCE (triamcinolone acetonide injectable suspension)
TRIESENCE · 1 trial · 2 indications
The proportion of subjects who achieve grade 0 anterior chamber cells (no detectable inflammatory cells) as assessed by slit-lamp biomicroscopy, indicating complete resolution of postoperative ocular inflammation.
The proportion of subjects reporting no ocular pain (score of 0 on the Numeric Pain Rating Scale \[NPRS\]), reflecting complete resolution of postoperative pain following ophthalmic surgery.
| Arm | Type | Description |
|---|---|---|
| TRIESENCE Treatment Arm | EXPERIMENTAL | Experimental Arm (TRIESENCE): Participants receive a single 100 µL subconjunctival injection of TRIESENCE (triamcinolone acetonide injectable suspension) administered at the conclusion of ophthalmic surgery. The injection is given under aseptic conditions to evaluate its effectiveness in reducing postoperative ocular inflammation and pain. |
| Placebo Comparator: Placebo (Sham) Control Arm | PLACEBO_COMPARATOR | Arm Description: Placebo Comparator Arm (Sham): Participants undergo a sham injection procedure at the end of surgery that mimics the active treatment process without administering TRIESENCE. This control is used to maintain masking and allow comparison of efficacy and safety outcomes. |
| Name | Type | Description |
|---|---|---|
| Sham (No Treatment) | PROCEDURE | Participants undergo a sham injection procedure at the end of surgery that mimics the active treatment process without administering TRIESENCE. This control is used to maintain masking and allow comparison of efficacy and safety outcomes. |
| TRIESENCE (triamcinolone acetonide injectable suspension) | DRUG | Participants receive a single 100 µL subconjunctival injection of TRIESENCE (triamcinolone acetonide injectable suspension) administered at the conclusion of ophthalmic surgery. The injection is given under aseptic conditions to evaluate its effectiveness in reducing postoperative ocular inflammation and pain. |
Inclusion Criteria: * Adults ≥18 years of age * Scheduled to undergo ophthalmic surgery, primarily cataract surgery with intraocular lens implantation (phacoemulsification) * Clear corneal incision ≤2.2 mm in the study eye * No ocular pain (NPRS = 0) in the study eye at baseline * No clinically sig...
TRIESENCE is an injectable suspension of triamcinolone acetonide, a small molecule corticosteroid. It is being developed by Harrow, Inc. (ticker HROW) as a treatment for postoperative ocular inflammation and pain following ophthalmic surgery. It is currently in Phase 3 clinical development.
TRIESENCE is being studied for the treatment of ocular inflammation and pain after ophthalmic surgery. Its Phase 3 trial enrolls adults 18 years and older who have undergone eye surgery, evaluating the injectable suspension for postoperative ocular inflammation and postoperative ocular pain.
TRIESENCE is developed by Harrow, Inc., which trades on the Nasdaq under the ticker HROW. Harrow is the sponsor of the Phase 3 study evaluating the injectable suspension for postoperative ocular inflammation and pain.
TRIESENCE is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for postoperative ocular inflammation or pain. One Phase 3 trial is currently active and enrolling by invitation in the United States.
TRIESENCE is being evaluated in a single Phase 3 trial, NCT07832552, titled A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery. The trial is randomized, double-blind, placebo-controlled, enrolling 250 participants in the United States.
Yes. TRIESENCE is the brand name for triamcinolone acetonide injectable suspension. The active ingredient is triamcinolone acetonide, a small molecule corticosteroid, formulated as an injectable suspension for postoperative ocular inflammation and pain.