Positive Topline Results from Phase 2 VVN461 Trial for Non-Infectious Anterior Uveitis

VivaVision Biotech has announced positive topline results from its Phase 2 clinical trial of VVN461, a dual JAK1/TYK2 inhibitor, for the treatment of Non-Infectious Anterior Uveitis (NIAU) in China.

Study Design and Methodology

This multicenter, double-masked, randomized, active-controlled, parallel-comparison study was conducted across 10 clinical sites in China. The study enrolled 86 patients diagnosed with NIAU, who were randomized into three groups:

       • VVN461 ophthalmic solution 1.0%

       • VVN461 ophthalmic solution 0.5%

       • Prednisolone acetate ophthalmic solution 1.0% (active control)

Patients received treatments for 28 days. Prednisolone acetate is recognized as the first-line corticosteroid therapy for NIAU.

Efficacy Outcomes

Both the 0.5% and 1.0% concentrations of VVN461 ophthalmic solution demonstrated non-inferior efficacy compared to prednisolone acetate for the study’s primary endpoint. Patients treated with VVN461 exhibited a two-step decrease in Anterior Chamber Cell (ACC) grade versus those treated with prednisolone acetate (p < 0.001). ACC grading was conducted using the Standardization of Uveitis Nomenclature (SUN) grading scale.

In addition to the primary endpoint, both VVN461 groups showed statistically significant and clinically meaningful improvements from baseline across most primary and secondary endpoints. The efficacy outcomes for the VVN461 groups were comparable to those observed in the prednisolone acetate group.

Safety Profile

No substantial treatment-related adverse events were reported in the trial, supporting VVN461’s excellent safety profile.

Expert Commentary

Professor Liu Yang, Director of Ophthalmology at Peking University First Hospital, commented on the results:

"I am very pleased to see that VVN461 showed non-inferior efficacy to prednisolone acetate in the Phase 2 clinical trial for NIAU in China. This is a very significant and potentially disruptive progress in treating uveitis. We hope that this safe, highly efficacious and accessible non-steroidal medicine, VVN461 would be available to benefit patients in near future."

Future Plans

The full data from this Phase 2 trial is expected to be reported in upcoming publications at conferences and in peer-reviewed journals. VivaVision Biotech has also scheduled a discussion with the Chinese Center for Drug Evaluation (CDE) and plans to request a Type C meeting with the U.S. Food and Drug Administration (FDA) to advance VVN461 into Phase 3 clinical trials.