VVN461 Trial Topline Results Announced for Non-Infectious Anterior Uveitis

VivaVision has just announced positive topline results from their China-based phase 2 trial of VVN461, a dual Janus kinase (JAK) inhibitor and tyrosine kinase 2 (TYK2) inhibitor for treating non-infectious anterior uveitis (NIAU).1

Uveitis is a major cause of vision loss, representing around 10-20% of cases of acquired legal blindness. It often recurs after treatment and can be chronic. Additionally, it affects approximately 3 million patients in China, with roughly 60% indicated as NIAU.1

Typical treatment of non-infectious uveitis centers around topical and systemic corticosteroids, like prednisolone and methylprednisolone. However, literature confirming the reliability and efficacy of corticosteroids are lacking. Additionally, although systemic corticosteroids are utilized in treating approximately 94% of children with non-infectious uveitis at any point during the course of the disease according to data from the North American Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry, therapeutic data were not included.2

“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,” said Liu Yang, MD, PhD, director of ophthalmology at Peking University First Hospital. “We hope that this safe, highly efficacious and accessible non-steroidal medicine, VVN461 would be available to benefit patients in [the] near future.”1

The trial was double-masked, randomized, active controlled, and parallel-comparison, conducted at 10 clinical sites in China and including 86 subjects. Participants were randomized into 3 groups – the first received VVN461-1.0%, the second VVN461-0.5%, and the third prednisolone acetate (PA)-1.0%. Participants received treatment for 28 days.1

Both the 0.5% and 1% cohorts showed non-inferior efficacy against the control PA cohort. Patients treated with VVN461 had 2-step decrease in ACC grade vs subjects treated with prednisolone acetate (P <.001). Additionally, both VVN461 dose groups exhibited statistically significant and clinically meaningful improvements from baseline across primary and secondary endpoints. There were no adverse effects related to treatment, confirming the drug’s safety profile.1

In December of 2024, VivaVision announced another successful trial of VVN461, this one to treat postoperative inflammation. Based on their pipeline, this treatment is in phase 1 testing and is awaiting FDA approval.3

VivaVision has also announced its intention to request a type C meeting with the US Food and Drug Administration (FDA) about phase 3 trials and an eventual biologics license application (BLA). Additionally, full data from the study will be released by VivaVision in future publications in conferences and journals.1

References

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

2. Schnabel A, Unger E, Brück N, et al. High-dose intravenous methylprednisolone in juvenile non-infectious uveitis: A retrospective analysis. Clinical Immunology. 2019;211:108327. doi:10.1016/j.clim.2019.108327

3. VivaVision Biotech. Vivavision Announces Positive Topline Results from Phase 2 Trial of VVN461 for Post-Operative Inflammation Following Cataract Surgery. BioSpace. December 5, 2024. Accessed April 25, 2025. https://www.biospace.com/press-releases/vivavision-announces-positive-topline-results-from-phase-2-trial-of-vvn461-for-post-operative-inflammation-following-cataract-surgery