VivaVision Reports Positive Phase 2 Results for VVN461 in Non-Infectious Anterior Uveitis

WENZHOU, China, April 24, 2025 – VivaVision Biotech has announced encouraging results from its recent phase 2 clinical trial of VVN461, a dual JAK1/TYK2 inhibitor being considered as a non-steroidal anti-inflammatory treatment for Non-Infectious Anterior Uveitis (NIAU) in China. This trial demonstrated that VVN461 met its primary endpoints, showing non-inferior efficacy compared to the standard therapy, prednisolone acetate (PA).

The clinical trial was a multicenter, double-masked, randomized, active-controlled study conducted across ten clinical sites in China, involving 86 participants diagnosed with NIAU. These individuals were divided into three treatment groups: VVN461 at concentrations of 1.0% and 0.5%, and prednisolone acetate at 1.0%. They received their respective treatments for a period of 28 days.

Both VVN461 concentrations displayed non-inferior efficacy when compared to the control group receiving prednisolone acetate. Participants treated with VVN461 showed a significant improvement in anterior chamber cells (ACC) grading, with a reduction of two steps compared to those treated with the standard steroid treatment, with a p-value of less than 0.001. This grading was assessed using the SUN (Standardization of Uveitis Nomenclature) grading scale.

The study results highlighted that both dosage groups of VVN461 brought about statistically significant and clinically meaningful improvements from baseline across several primary and secondary endpoints. The efficacy observed in the VVN461 groups was comparable to that of the prednisolone acetate group. Furthermore, the trial reinforced the safety profile of VVN461, as no substantial treatment-related adverse effects were reported.

Uveitis is characterized by the inflammation of the uvea, comprising the iris, ciliary body, and choroid, and affects nearly three million people in China. Approximately 60% of these cases are classified as non-infectious anterior uveitis. Given that uveitis can be recurrent and chronic, it stands as a significant cause of vision impairment, contributing to 10–20% of cases of acquired legal blindness. Presently, topical steroids are the common treatment for NIAU, but they are linked with adverse effects, including elevated intraocular pressure, slowed wound healing, and ocular infections. Extended use of such steroids can lead to severe complications like ocular hypertension and cataracts.

VVN461 offers a promising therapeutic alternative due to its targeted non-steroidal mechanism, which aims to reduce these risks while maintaining anti-inflammatory efficacy. The promising results from the phase 2 trial suggest that VVN461 could pave the way for safer treatment options for patients, addressing a significant unmet clinical need.

Following these findings, VivaVision Biotech is preparing to engage 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) in anticipation of phase 3 clinical trials.

VivaVision Biotech, founded in 2016, focuses on developing advanced therapies for ocular diseases. The company is progressing with several investigational drug candidates, including VVN461, which is also being evaluated for postoperative inflammation post-cataract surgery. Their pipeline also features other innovative treatments targeting various ocular conditions, demonstrating VivaVision's commitment to addressing the unmet needs in eye health.