Harrow has received FDA clearance for its investigational new drug (IND) application to initiate a phase 3 clinical trial that will evaluate TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL for the treatment of ocular inflammation and pain following cataract surgery.
Wait … isn’t TRIESENCE already approved?
Indeed, it is. This phase 3 trial would support an on-label expansion of the formulation.
Gotcha. But before we talk about that, can we get a rundown on the drug?
But of course. We’ll begin with its regulatory history.
FDA-approved in 2007, the corticosteroid underwent a few ownership changes over the years before Harrow acquired it in 2023.
Most recently: TRIESENCE was commercially (re-)launched in the U.S. in late 2024 under the Harrow name following years of supply issues.
- And in March 2025: It was granted transitional pass-through reimbursement status by the Centers for Medicare & Medicaid Services (CMS).
And what exactly is TRIESENCE?
TRIESENCE is a preservative-free (PF) synthetic corticosteroid indicated for:
- Visualization during vitrectomy
- Treating ocular inflammatory conditions unresponsive to topical corticosteroids, including:
- Sympathetic ophthalmia
- Temporal arteritis
- Uveitis
What are the recommended dosages?
For its visualization indication: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension), administered intravitreally.
For those aforementioned ocular inflammatory conditions: 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment.
Noted. Now, expand on this … expanded labeling intent.
Harrow is looking to expand on-label TRIESENCE usage to all cataract surgery patients—not just those who face postop eye drop adherence challenges.
The intent: Is to not only increase the number of patients eligible for the PF, anti-inflammatory therapy at the time of surgery, but also reduce reliance on patients’ self-administering a multi-week, at-home eye drop regimen, Harrow noted.
- And for physicians: The label expansion would give them “greater control over post-operative inflammation management.”
So, in a nutshell: There’s a demand (and interest) for a simplified perioperative care among both patients and surgeons.
And the purpose of this phase 3 trial?
Referred to as a critical opportunity to “further strengthen (TRIESENCE’s) clinical and commercial profile,” the study is designed to generate key data supporting its use for managing postoperative inflammation and pain after cataract surgery.
And if successful: The trial could “reinforce (the corticosteroid’s) role as a differentiated and meaningful option for both physicians and patients.”
So what do we know about it?
Here’s what Harrow has shared thus far:
- The design: A randomized, placebo-controlled, double-masked, multicenter study
- The participants: An estimated 250 patients receiving treatment for ocular inflammation and pain following cataract surgery
- The setup: Patients to be randomized 2:1 to receive either TRIESENCE or a placebo
- The duration: 120 days per patient (last clinic visit on Day 90)
- The outcome measures: Primary endpoints include:
- Absence of anterior chamber cells in the study eye (Day 14)
- Absence of pain in the study eye (Day 8)
When will the study kick off?
The trial’s initiation is planned for Q1 2026 (translation: sometime between now and March 31).
Patient enrollment is expected to begin in Q2 2026 (April 1 to June 3).
Any timeframe for a topline data readout yet?
Alas, not so far. As always .. stay tuned for more details on this!