Cranbury, NJ, March 12, 2024 — iView Therapeutics Inc., a clinical stage biotechnology company dedicated to advancing innovative treatments for ocular diseases, announces that the U.S. Food and Drug Administration (FDA) cleared iView’s Investigational New Drug (IND) application to for the initiation of a Phase 1/2 clinical trial as safe to proceed. The trial will evaluate the Safety, Tolerability, and Efficacy of IVW-1001, a novel TRPM8 agonist, to treat signs and symptoms of dry eye diseases.

The IND clearance for IVW-1001 marks a significant step forward in iView Therapeutics’ mission to provide innovative solutions for individuals suffering from dry eye diseases with suboptimal effects on artificial tears. With FDA’s clearance of the IND application, iView Therapeutics Inc. anticipates moving swiftly into Phase 1/2 clinical trials in the second quarter of 2024.

Dry eye diseases represent a prevalent and burdensome condition affecting millions worldwide. IVW-1001, developed by iView Therapeutics Inc., offers promising potential as a therapeutic intervention, leveraging its TRPM8 agonist mechanism to target the underlying causes of dry eye.

Houman Hemmati, MD, PhD, Chief Medical Advisor, who heads the clinical development of the IVW-1001 program, commented, “As we embark on this exciting phase of clinical development for IVW-1001, our focus remains steadfast on rigorously evaluating its safety, tolerability, and potential efficacy. This investigational TRPM8 agonist represents an innovative approach in the treatment of dry eye diseases, a condition that challenges millions worldwide. FDA’s clearance of the IND is a critical milestone in our commitment to addressing the unmet needs of these patients through innovative science and targeted therapeutic development. We look forward to the possibility of advancing care in this important area.”

Bo Liang, PhD, MBA, Co-founder, Chairman, and CEO of iView Therapeutics Inc., expressed his enthusiasm, “We are very pleased that FDA cleared our IND to initiate the clinical development of this novel compound. The novel mechanism of TRPM8 activation and an innovative delivery route of administration through eyelid wipe to treat both signs and symptoms of dry eye diseases will provide potentially a very differentiated product for dry eye treatment worldwide. We are on track to initiate the Phase I/II trial to dose dry eye patients directly in the first-in-human (FIH) clinical trials in Q2 2024.”