Positive topline results from phase 2 VVN461 trial for non-infectious anterior uveitis

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VivaVision Biotech has announced the positive topline results from its phase 2 clinical trial of the candidate VVN461, a dual JAK1/TYK2 inhibitor for the treatment of Non-Infectious Anterior Uveitis (NIAU) in China.¹

This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at 10 clinical sites in China. The study enrolled 86 patients with NIAU and randomized them into 3 groups (VVN461-1.0%, VVN461-0.5%, and prednisolone acetate-1.0%). Patients received treatments for 28 days. Prednisolone acetate is the first-line corticosteroid therapy for NIAU.

Both 0.5% and 1% of VVN461 ophthalmic solutions showed non-inferior efficacy compared to active control PA for its primary endpoint. Patients treated with VVN461 had 2 step decrease in ACC grade vs. subjects treated with prednisolone acetate (p <0.001). ACC (anterior chamber cells) were evaluated using SUN grading scale.

Both VVN461 dose groups demonstrated statistically significant and clinically meaningful improvements from baseline across most primary and secondary endpoints. The efficacy of VVN461 groups were comparable to prednisolone acetate group. No substantial treatment-related adverse events were reported, confirming VVN461's excellent safety profile.

Professor. Liu Yang, Director of Ophthalmology at Peking University First Hospital is quoted in the company’s release¹ on this trial news, saying, "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."

Full data from this trial is expected to be reported in future publications at conferences and in journals.

VivaVision has scheduled a discussion with Chinese CDE and is planning to request a type C meeting with FDA about phase 3 clinical trials.

Reference:

1. VivaVision Announces Positive Topline Results from Phase 2 Trial of VVN461 for Non-Infectious Anterior Uveitis. April 24, 2025. Accessed April 25, 2025. https://www.prnewswire.com/news-releases/vivavision-announces-positive-topline-results-from-phase-2-trial-of-vvn461-for-non-infectious-anterior-uveitis-302437223.html