Harrow receives FDA IND clearance for phase 3 trial of TRIESENCE after cataract surgery

Harrow has received clearance from the US Food and Drug Administration (FDA) on its Investigational New Drug (IND) application supporting a planned phase 3 clinical trial evaluating TRIESENCE (preservative-free triamcinolone acetonide injectable suspension) 40 mg/mL for the treatment of ocular inflammation and pain following cataract surgery.¹

TRIESENCE is an FDA-approved preservative-free triamcinolone formulation for intraocular use and is widely utilized by ophthalmologists for the treatment of ocular inflammation. Harrow announced the relaunch of TRIESENCE in October 2024 after more than 5 years on the FDA Drug Shortage List and 2 years of inventory depletion.²

The study is designed to generate “robust data” supporting its use in managing postoperative inflammation and pain following cataract surgery, with the potential to expand the product’s label.¹

Harrow noted that expanding on-label TRIESENCE usage to all cataract surgery patients will “increase the number of patients benefiting from a preservative-free, sustained anti-inflammatory therapy at the time of surgery, reducing reliance on patients self-administering complex, multi-week at-home eye drop regimens—and addressing a well-recognized compliance challenge in post-cataract surgery care while providing physicians with greater control over post-operative inflammation management.”

The phase 3 trial is planned to be a randomized, placebo-controlled, double-masked, multicenter clinical study. Approximately 250 patients will be enrolled and randomized at 2:1 to receive either TRIESENCE or placebo. The primary efficacy endpoints are the absence of anterior chamber cells in the study eye at day 14 and the absence of pain in the study eye at day 8 following cataract surgery. Each patient will participate in the trial for approximately 120 days, with the last visit occurring on day 90.

Amir Shojaei, chief scientific officer of Harrow, commented on the trial in a press release from the company, “[TRIESENCE’s] clinical profile provides significant benefits, including effective management of postoperative inflammation and pain while enabling physicians to maintain greater control over both the procedure and the recovery process. By reducing reliance on complex at-home eye drop regimens—where compliance can be inconsistent, particularly among older patients—TRIESENCE addresses a well-recognized challenge in post-cataract removal care. We believe this phase 3 study will generate high-quality data to further support its clinical value, expand its potential role in post-cataract surgery treatment, and strengthen its long-term commercial opportunity.”

Enrollment for the trial is anticipated to start in Q2 of 2026.

References:

1. Harrow to Initiate Phase 3 Clinical Trial Seeking to Expand TRIESENCE® Label to Include Ocular Inflammation and Pain Following Cataract Surgery Indication. Published March 3, 2026. Accessed March 6, 2026 https://www.harrow.com/news-releases/news-release-details/harrow-initiate-phase-3-clinical-trial-seeking-expand-triesencer

2. Hutton D. Harrow relaunches triamcinolone acetonide injectable suspension. Published October 3, 2024. Accessed March 6, 2026. https://www.ophthalmologytimes.com/view/harrow-relaunches-triamcinolone-acetonide-injectable-suspension