Harrow announced that the FDA has cleared its Investigational New Drug (IND) application to support a planned phase 3 clinical trial evaluating Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL for the treatment of ocular inflammation and pain following cataract surgery.

The planned phase 3 study is a randomized, placebo-controlled, double-masked, multicenter clinical trial designed to assess the safety and efficacy of preservative-free Triesence in patients undergoing cataract surgery. Harrow expects to initiate the study in the first quarter of 2026, with patient enrollment anticipated to begin in the second quarter of 2026.

Triesence is an FDA-approved, preservative-free formulation of triamcinolone acetonide for intraocular use. By pursuing an expanded on-label indication for use in all cataract surgery patients, Harrow aims to increase access to a sustained, preservative-free anti-inflammatory therapy administered at the time of surgery. 

“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 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.”

About the Planned Phase 3 Study

  • Design: Randomized, placebo-controlled, double-masked, multicenter clinical study

  • Indication: Treatment of ocular inflammation and pain following cataract surgery

  • Planned Enrollment: Approximately 250 patients

  • Randomization: 2:1 (Triesence: placebo)

  • Primary Endpoints:

    • Absence of anterior chamber cells in the study eye at Day 14

    • Absence of pain in the study eye at Day 8

  • Study Duration: Approximately 120 days per patient; final visit at Day 90

  • Study Initiation: First quarter of 2026

  • Enrollment Start: Second quarter of 2026