iView Therapeutics Inc. has announced the completion of patient recruitment for its Phase 1/2 clinical trial (NCT06400459) evaluating IVW-1001 for the treatment of dry eye disease (DED). The company anticipates reporting topline data in the first quarter of 2025.
Trial Design and Objectives
The Phase 1/2 trial is designed as a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study. It aims to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipe at two different concentrations: 0.2% (high dose) and 0.1% (low dose). A placebo (vehicle) will serve as the control. The primary outcome measures focus on assessing the improvement in signs and symptoms associated with dry eye disease.
IVW-1001: A Novel TRPM8 Agonist
IVW-1001 is a novel TRPM8 agonist delivered via an ophthalmic eyelid wipe. It is being developed as a potential treatment for DED. The drug is designed to increase tear secretion and alleviate pain symptoms by acting on the TRPM8, or transient receptor potential cation channel subfamily M member 8. TRPM8 is expressed on sensory neurons in the cornea and eyelid.
Mechanism of Action and Previous Findings
IVW-1001 has previously demonstrated a short duration of action and improvement in key signs and symptom relief in an Investigator Sponsored Clinical Trial. It was shown to increase tear production within 5-20 minutes of administration, with longer-lasting effects observed after two weeks of administration. Notably, these benefits were not accompanied by any adverse events.
Management Commentary
"The completion of patient recruitment ahead of schedule is a testament to the dedication of our clinical team and the interest from the ophthalmic community," said Bo Liang, PhD, MBA, co-founder, chairman, and CEO of iView Therapeutics Inc. "IVW-1001's novel mechanism of TRPM8 activation and its innovative delivery through an ophthalmic eyelid wipe could offer a differentiated treatment for dry eye disease worldwide. We look forward to sharing our findings as soon as they are available."
Houman Hemmati, MD, PhD, Chief Medical Advisor at IVIEW Therapeutics Inc., added, "Completing patient enrollment brings us one step closer to potentially offering a new therapeutic option for individuals suffering from dry eye disease. We are eagerly awaiting the trial results and remain optimistic about the potential impact on patient care."
