The planned Phase 3 study is a randomized, placebo-controlled, double-masked, multicenter clinical trial designed to evaluate the safety and efficacy of TRIESENCE in patients undergoing cataract surgery. Harrow expects to initiate the study in the first quarter of 2026.

TRIESENCE is an FDA-approved triamcinolone preservative-free formulation for intraocular use and is widely utilized by ophthalmologists for the treatment of ocular inflammation. Adoption has been particularly strong among surgeons treating cataract patients, for whom post-operative eye drop adherence can be challenging due to dexterity hurdles, cognitive limitations, compliance concerns, limited caregiver support, or other age-related comorbidities. By expanding on-label TRIESENCE usage to all cataract surgery patients, Harrow 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.

Harrow believes the planned Phase 3 trial represents an important opportunity to further strengthen the clinical and commercial profile of TRIESENCE. The study is designed to generate robust data supporting its use in managing post-operative inflammation and pain following cataract surgery, with the potential to expand the product's label. If successful, the trial could reinforce its current role as a differentiated and clinically meaningful option for both physicians and patients. In addition, these data would further support Harrow's long-term vision of delivering solutions that streamline surgical workflows, reduce reliance on opioids and IV sedation, and simplify post-operative care. TRIESENCE is central to this strategy and reinforces Harrow's commitment to advancing a more efficient, patient-focused cataract surgery paradigm.

The Phase 3 trial is expected to enroll approximately 250 patients who will be randomized in a 2:1 ratio 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 study for approximately 120 days, with the final visit occurring on Day 90.