IVIEW Therapeutics Inc. has reported positive topline results from its Phase 1/2 clinical trial evaluating IVW-1001, an innovative TRPM8 agonist delivered through an ophthalmic eyelid wipe for dry eye disease treatment. The study, conducted across 10 U.S. sites, enrolled 150 patients to assess the safety and efficacy of two different concentrations of the drug.
Safety and Tolerability Profile
The trial demonstrated a favorable safety profile for IVW-1001 across all treatment groups. While ocular irritation was reported as the most common adverse event, it affected only 3% of patients in the treatment groups compared to none in the vehicle group. Notably, no serious adverse events related to the investigational product were reported, and no patients withdrew from the study due to treatment-related adverse events.
Efficacy Outcomes
The 0.2% concentration of IVW-1001 emerged as particularly effective, showing statistically significant improvements in multiple key endpoints at Week 4:
- Total Corneal Fluorescein Staining decreased by 1.7 points compared to 1.3 for vehicle (p=0.0097)
- Eye Dryness Score improved by 22.8 points versus 18.3 for vehicle (p=0.0315)
- SANDE symptom frequency scores reduced by 14.4 points compared to 9.0 for vehicle (p=0.0017)
The data revealed a clear dose-response relationship, with the higher concentration consistently demonstrating superior efficacy. Positive trends were also observed in both basal and reflex tear production measurements.
Novel Delivery Mechanism
IVW-1001's unique delivery system via an ophthalmic eyelid wipe represents a innovative approach to dry eye treatment. This delivery method, combined with the TRPM8 agonist mechanism of action, differentiates it from existing therapeutic options in the market.
Expert Perspectives
"These results provide a strong foundation for advancing into pivotal trials with confidence," stated Dr. Houman Hemmati, Chief Medical Advisor at IVIEW Therapeutics. "The data underscore IVW-1001's potential to address both the signs and symptoms of dry eye disease."
Bo Liang, PhD, MBA, Co-founder and CEO, emphasized the significance of the results: "The statistically significant and clinically meaningful improvements observed across both signs and symptoms reaffirm the potential of our TRPM8 agonist program to address the unmet needs of patients with dry eye disease."
Development Pathway
Based on these encouraging results, IVIEW Therapeutics plans to advance IVW-1001 into larger pivotal trials. The company aims to further evaluate the treatment's efficacy and safety in an expanded patient population, moving closer to providing a new therapeutic option for dry eye disease patients.
