VivaVision Announces Positive Phase II Clinical Trial Results for VVN001 in Dry Eye Disease

Shanghai, March 23, 2022 /PRNewswire/ -- VIVAVISION, a clinical-stage biotechnology company focused on ophthalmology, is pleased to announce today that its self-developed innovative drug VVN001 has achieved positive results in the U.S. Phase II clinical trial for dry eye disease.

This randomized, double-blind, vehicle-controlled Phase II clinical trial aims to evaluate the safety and efficacy of VVN001 in treating patients with moderate to severe dry eye disease. The study enrolled a total of 170 patients across 14 clinical trial centers in the United States, who were randomly assigned to receive either VVN001 (5%), VVN001 (1%), or the vehicle. During the 84-day treatment period, patients administered the eye drops twice daily and were assessed on Days 1, 14, 28, 56, and 84.

The primary efficacy endpoint of this study was the improvement in inferior corneal fluorescein staining from baseline. After completing the 84-day treatment period, this endpoint demonstrated the favorable therapeutic effect of VVN001, with the 5% treatment group showing significantly greater improvement compared to the control group. In total corneal fluorescein staining, the VVN001 treatment group exhibited clinically and statistically significant improvements over the vehicle group, along with a good dose-response and time-effect relationship. A similar improvement was observed in Schirmer scores for tear secretion. Additionally, the pre-specified secondary clinical endpoint, Symptom Assessment in Dry Eye (SANDE) frequency and severity scores, showed significant improvement from baseline and compared to the control group.

In terms of safety, no significant treatment-related adverse events were observed in the study, indicating that both dose groups of VVN001 demonstrated good safety and tolerability. Mild irritation at the administration site was the only treatment-related adverse event with an incidence rate greater than 3%. The incidence rates in the VVN001 treatment group and the vehicle group were 3.5% and 3.6%, respectively.

Joseph Tauber, MD, an internationally renowned dry eye treatment expert from the Tauber Eye Center in the United States, said: "A large number of patients are troubled by dry eye problems, and there is an urgent need for new therapeutic drugs to help doctors and patients better manage dry eye disease. The results of this Phase II clinical trial demonstrate that VVN001 has statistically significant reductions in total corneal and regional corneal fluorescein staining scores compared to the vehicle group."

Dr. Joanne Li, Chief Medical Officer of VIVAVISION, commented, "We are very pleased to see that VVN001 significantly improved patients' dry eye symptoms and signs in this first-in-human clinical study. The positive results of this Phase II clinical trial will strongly support VIVAVISION's upcoming Phase III clinical research."