Shanghai, the PRC --On March 23rd, 2022, VivaVision Biotech, Inc. (VivaVision), invested and incubated by Viva BioInnovator, an ophthalmic pharmaceutical developer focusing on discovery and development of innovative therapies for ocular diseases, today announced positive topline results from a Phase 2 clinical study of VVN001 in patients with dry eye disease.
The randomized, 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. 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," said Joseph Tauber, M.D., Tauber Eye Center, Kansas City, MO. "This VVN001 study demonstrated that VVN001 achieved statistical superiority over vehicle in reducing total and sub-regional Corneal Fluorescein Staining scores."
"In this first-in-human study, we are very pleased to see that clinically relevant and statistically significant improvement over vehicle in both signs and symptoms was achieved for VVN001", commented Joanne Li, MD, Chief Medical Officer of VivaVision. "We are also encouraged by the promising trends seen in the symptom endpoints. The results from this phase 2 study will inform the design of future phase 3 clinical studies."
VVN001 is a potent and novel second-generation LFA-1 inhibitor. In addition to the recently completed Phase 2 study in the United States, a Phase 1 pharmacokinetic study was completed in healthy volunteers in China. A Phase 2 clinical study with a similar study design to the one in the United States is currently ongoing in China. Based on the outcomes from the Phase 2 study results in the United States, VVN001 (5%) will be advanced to Phase 3 studies both in China and the U.S.
About VivaVivion Biotech, Inc.
VivaVision is a clinical stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. Besides VVN001 program, VivaVision is developing VVN539 for the treatment for Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. VivaVision is also engaged in discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases. To learn more about VivaVision, Visit : www.vivavisionbio.com