HARROW INC · Data as of 2026-09-08
early 2027
● TRIESENCE: The Company's Phase 3 trial evaluating TRIESENCE for the treatment of ocular inflammation and pain following cataract surgery is on track to fully enroll in 2026, with topline data expected in early 2027.Source filing
Q4 2026
● IHEEZO (QUELL): Topline data from QUELL, a prospective, randomized, multi-center clinical trial evaluating IHEEZO in patients undergoing intravitreal injections, are expected in the fourth quarter of 2026.Source filing
H1 2028
● Regulatory Review and Approval (H1 2028): Engage collaboratively with the FDA through the review process, with potential approval in the first half of 2028.Source filing
H1 2027
In support of a new drug application (an "NDA") filing, we recently initiated one non-clinical animal study and three pharmacokinetic ("PK") studies to generate the balance of the data we believe is necessary for an NDA package. Following completion of these studies, we expect to prepare and submit an NDA for MELT-300 in the first half of 2027. If promptly approved by the FDA, we expect to commercially launch MELT-300 in the second half of 2028.Source filing
Q4 2026
● NATACYN ® : The first patients were enrolled in an investigator-initiated clinical study during the second quarter, with topline data expected in the fourth quarter of 2026.Source filing
By Jan 2028
To support our long-term intentions, we have launched a clinical study designed to expand the TRIESENCE label to expressly include cataract surgery and pain—a development positioned to materially broaden its commercial opportunity. The study is underway, and we expect the last patient visit by the end of this year with top-line data shortly thereafter. We are also developing a pre-filled syringe (PFS) format for TRIESENCE. Once again, this program is underway, and we expect to present a filing to the FDA within the next 18-20 months.Source filing