A Phase 3, Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Placebo-Controlled Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery

This document is Protocol TR-03-001, dated 26 January 2026, for a Phase 3, prospective, multicenter, randomized, parallel-arm, double-masked, placebo-controlled clinical trial sponsored by Harrow Inc. The study evaluates TRIESENCE® (triamcinolone acetonide injectable suspension) given as a 100 µL subconjunctival injection for the treatment of ocular inflammation and pain after ophthalmic surgery. The protocol says about 250 subjects will be enrolled across 16 sites, with total subject participation of about 120 days including screening, surgery, postoperative follow-up through Day 90, and a possible safety follow-up to Day 120.

The target population is adults aged 18 years or older undergoing ophthalmic surgery, especially cataract surgery with intraocular lens implantation, and more specifically phacoemulsification cataract surgery through a clear corneal incision of 2.2 mm or less in the study eye. Subjects must have no baseline ocular pain in the study eye, no pre-existing intraocular inflammation, and must satisfy extensive medical and ophthalmic eligibility criteria. The inclusion and exclusion sections are detailed, ruling out patients with uncontrolled ocular or systemic disease, glaucoma or elevated IOP risk, active infection, inflammatory eye disease, significant retinal or macular pathology, recent ocular surgery, certain concurrent medications, hypersensitivity to study drug components, and a number of surgical or anatomical factors that could confound outcomes or raise safety concerns.

The main purpose of the study is to determine whether TRIESENCE is safe and effective for controlling post-surgical ocular inflammation and pain when administered subconjunctivally at the end of surgery. The protocol lists one primary objective and several secondary objectives. The primary objective is to evaluate the safety and efficacy of TRIESENCE for post-surgical inflammation and pain. Secondary objectives include further characterizing tolerability, evaluating intraocular pressure changes, assessing investigator-reported ease of administration, and describing the need for rescue anti-inflammatory medications such as topical NSAIDs and corticosteroids.

The trial has two co-primary efficacy endpoints. The first is the proportion of subjects who have no anterior chamber cells (grade 0) at Day 14 after surgery, which is the protocol's measure of absence of anterior chamber inflammation. The second is the proportion of subjects with no ocular pain at Day 8 after surgery, defined as NPRS = 0. Study success requires that both co-primary endpoints achieve statistical significance. The protocol is explicit that failure on either endpoint means the study fails its primary efficacy objective.

Secondary efficacy endpoints include repeated assessment of anterior chamber cell grade, anterior chamber flare, and ocular pain scores at postoperative Days 2, 4, 8, 14, 30, 60, and 90. The protocol also tracks use of rescue medications and investigator-assessed ease of injection. On page 20, there is a grading table for anterior chamber cells and flare. Cells are graded from 0 to 4+, where grade 0 means no cells and grade 4+ means more than 50 cells in the field. Flare is graded from 0 to 4+, with qualitative descriptions ranging from none to intense fibrin or plastic aqueous. On page 21, a visual pain scale graphic shows the 0 to 10 pain scale grouped into mild, moderate, and severe categories.