Harrow Initiates Phase 3 Trial for TRIESENCE to Expand Indications

Harrow, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 3 clinical trial for TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL. This trial aims to evaluate the drug's effectiveness in treating ocular inflammation and pain following cataract surgery. Although TRIESENCE is already FDA-approved for intraocular use, this trial seeks to expand its labeling to include all cataract surgery patients, thereby addressing a broader patient demographic.

FDA clears Harrow's IND to initiate phase 3 trial on TRIESENCENasdaq

Originally approved by the FDA in 2007, TRIESENCE has undergone several ownership changes before being acquired by Harrow in 2023. The drug was commercially relaunched in the U.S. in late 2024 after facing supply issues. In March 2025, it received transitional pass-through reimbursement status from the Centers for Medicare & Medicaid Services (CMS). TRIESENCE is a preservative-free corticosteroid indicated for various ocular inflammatory conditions, including sympathetic ophthalmia, temporal arteritis, and uveitis.

FDA clears Harrow's IND to initiate phase 3 trial on TRIESENCE

The Phase 3 trial is designed as a randomized, placebo-controlled, double-masked, multicenter study involving approximately 250 patients. Participants will be randomized in a 2:1 ratio to receive either TRIESENCE or a placebo. The trial will last 120 days per patient, with the last clinic visit occurring on Day 90. Primary endpoints include the absence of anterior chamber cells in the study eye by Day 14 and the absence of pain in the study eye by Day 8. The trial is set to begin in the first quarter of 2026, with patient enrollment expected to start in the second quarter.

FDA clears Harrow's IND to initiate phase 3 trial on TRIESENCENasdaq

Following the FDA's announcement, Harrow's stock experienced a significant decline, falling approximately 21% to $41.94. This drop reflects investor concerns despite the potential benefits of expanding TRIESENCE's indications. The stock has fluctuated between $20.85 and $54.85 over the past year. Analysts note that expanding the drug's label could alleviate challenges related to eye drop adherence, particularly among older patients who may struggle with dexterity or cognitive limitations.

Nasdaq

Despite the potential benefits of the trial, some analysts express skepticism regarding the market's reaction to the news. The sharp decline in stock price raises questions about investor confidence in Harrow's strategy and the trial's outcomes. Critics argue that the company's focus on expanding TRIESENCE's indications may not sufficiently address the broader challenges faced by ophthalmologists and patients in managing postoperative care.

Nasdaq

As the trial progresses, Harrow aims to generate critical data that will support the expanded use of TRIESENCE for managing postoperative inflammation and pain after cataract surgery. The company has not yet provided a timeline for a topline data readout, leaving stakeholders awaiting further developments.

FDA clears Harrow's IND to initiate phase 3 trial on TRIESENCE

• “further strengthen (TRIESENCE’s) clinical and commercial profile,” — Harrow, Inc.

FDA clears Harrow's IND to initiate phase 3 trial on TRIESENCE