Harrow (NASDAQ:HROW) said Tuesday that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application, paving the way for a Phase 3 clinical trial of TRIESENCE® (preservative-free triamcinolone acetonide injectable suspension) 40 mg/mL in patients undergoing cataract surgery.
The late-stage study will evaluate TRIESENCE for the treatment of ocular inflammation and pain following cataract surgery, with the goal of expanding the product’s label. Harrow expects to begin enrolling patients in the first quarter of 2026.
The randomized, double-masked, placebo-controlled, multicenter trial will assess both safety and efficacy in approximately 250 patients, who will be assigned in a 2:1 ratio to receive either TRIESENCE or placebo. The primary endpoints include the absence of anterior chamber cells at Day 14 and the absence of ocular pain at Day 8 post-surgery. Patients will be followed for about 120 days, with a final visit on Day 90.
Addressing Post-Surgical Inflammation in a Growing Market
Cataract surgery remains one of the most frequently performed procedures in the U.S., with more than 4 million operations annually—a figure expected to climb as the population ages. As volumes rise, surgeons and health systems are increasingly focused on improving workflow efficiency, simplifying post-operative care and enhancing patient experience.
Market research suggests strong interest in reducing or eliminating the need for post-surgical eye drops. A Market Scope survey of U.S. cataract surgeons found that nearly 90% expressed interest in a dropless surgical approach, with roughly half describing themselves as highly interested. The survey also indicated a meaningful preference among patients for avoiding post-operative drop regimens.
TRIESENCE is already FDA-approved for intraocular use and is widely used by ophthalmologists to manage ocular inflammation. The preservative-free formulation has seen growing adoption among cataract surgeons, particularly given the compliance challenges many patients face with multi-week, at-home eye drop schedules—often due to dexterity issues, cognitive limitations or limited caregiver support.
If the Phase 3 study is successful, Harrow aims to broaden on-label use of TRIESENCE to all cataract surgery patients, potentially reducing reliance on complex post-operative drop regimens while giving physicians greater control over inflammation management at the time of surgery.
Harrow said the trial represents a key step in strengthening both the clinical positioning and commercial prospects of TRIESENCE. Beyond inflammation control, the company sees the therapy as part of a broader strategy to streamline cataract procedures, reduce dependence on opioids and IV sedation, and simplify recovery protocols.
“This study marks an important milestone for TRIESENCE and for Harrow,” said Amir Shojaei, Chief Scientific Officer of Harrow. “TRIESENCE is already making a meaningful difference for patients with ocular inflammation by delivering sustained anti-inflammatory control at the time of surgery. Its clinical profile provides significant benefits, including effective management of post-operative 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.”
About Harrow
Harrow, Inc. (Nasdaq: HROW) is a North America-based ophthalmic pharmaceutical company focused on managing diseases affecting both the anterior and posterior segments of the eye. Its portfolio addresses conditions including dry eye disease, wet age-related macular degeneration, cataracts, refractive errors, glaucoma and other ocular surface and retinal disorders. The company positions itself around improving patient compliance and clinical outcomes through accessible and cost-effective treatment options.