According to the company, VVN001 demonstrated clinical and statistical superiority over vehicle in reducing total and sub-regional corneal fluorescein staining scores.
VivaVision Biotech Inc. (VivaVision) has released positive topline results from a Phase 2 clinical study of VVN001 in patients with dry eye disease.
According to the company, the randomly assigned, double-masked, vehicle-controlled Phase 2 clinical study was conducted at 14 centers across the United States and evaluated the safety and efficacy of VVN001 in patients with dry eye disease. A total of 170 patients were randomized into three groups, VVN001 (5%), VVN001 (1%) or VVN001 vehicle. The patients were treated twice daily over 84 days, and were evaluated at Days 1, 14, 28, 56 and 84.
After 84 days of dosing, a treatment effect was seen in the a priori primary efficacy endpoint of inferior corneal staining. Subjects in both the 1% and 5% treatment group improved, as well as the vehicle group. The improvement in the 5% treatment group was greater than in vehicle. In total corneal staining, there was a statistically and clinically significant improvement, and a dose and treatment duration-related improvement relative to vehicle.
The news release noted that similar effects were seen in the sign of clinically significant improvement in Schirmer scores. In the a priori selected symptom, SANDE scores, there was a statistically and clinically significant improvement from baseline, as well as a difference from the vehicle.
Both concentrations of VVN001 were safe and well-tolerated, with no significant treatment-related safety findings observed during the study. The only treatment-related safety finding with greater than 3% of patients was instillation site pain, which was reported in 3.5% of patients treated with VVN001, compared to 3.6% of patients treated with vehicle.
"Millions of people are living with dry eye disease and new treatment options are needed to help physician and patients better manage this disease," Joseph Tauber, MD, of the Tauber Eye Center in Kansas City, Missouri, said in the news release. "This VVN001 study demonstrated that VVN001 achieved statistical superiority over vehicle in reducing total and sub-regional Corneal Fluorescein Staining scores."
Joanne Li, MD, chief medical officer of VivaVision, noted in the news release that in the first-in-human study, the company was pleased to see that clinically relevant and statistically significant improvement over vehicle in both signs and symptoms was achieved for VVN001.
“We are also encouraged by the promising trends seen in the symptom endpoints,” she concluded in a statement. “The results from this phase 2 study will inform the design of future phase 3 clinical studies."