VivaVision's VVN461 Shows Promising Results in Phase 2 Trial for Non-Infectious Anterior Uveitis Treatment

Promising Progress for Non-Infectious Anterior Uveitis Treatment

VivaVision Biotech, a clinical-stage biotechnology company, recently announced encouraging topline results from its Phase 2 clinical trial of VVN461, aimed at treating Non-Infectious Anterior Uveitis (NIAU). Conducted across 10 clinical sites in China, this trial involved 86 subjects who were assigned to one of three treatment groups: VVN461 (0.5% and 1%) and the current standard treatment, prednisolone acetate (1.0%). Over a 28-day period, the efficacy and safety of VVN461 were assessed.

Key Outcomes of the Trial

Notably, both concentrations of VVN461 demonstrated non-inferior efficacy when compared to the standard treatment of prednisolone acetate. Patients treated with VVN461 experienced a clinically significant two-step decrease in anterior chamber cells (ACC) compared to those receiving prednisolone acetate, showcasing statistical significance (p < 0.001). Both doses of VVN461 also exhibited meaningful improvements across various primary and secondary endpoints when compared to baseline values. Importantly, there were no significant adverse events linked to the treatment, reaffirming the safety of VVN461.

Significance of the Findings

This trial's results represent a substantial advancement in the management of uveitis, a condition affecting about 3 million individuals in China, of which roughly 60% suffer from NIAU. Uveitis can lead to chronic inflammation and is a major cause of vision impairment, accounting for a significant percentage of legal blindness cases. Conventional treatments typically involve steroidal therapies, which come with a host of potential side effects, such as increased intraocular pressure and cataract formation due to prolonged use. In contrast, VVN461 offers a targeted, non-steroidal approach to minimize these risks while effectively combating inflammation.

Professor Liu Yang, Director of Ophthalmology at Peking University First Hospital, remarked on the promising results, stating, "The fact that VVN461 demonstrated efficacy comparable to prednisolone acetate marks a significant milestone in uveitis treatment. We are hopeful that VVN461 can soon be made available to patients and help ease their burdens."

Future Directions at VivaVision

In light of these promising results, VivaVision plans to discuss the findings with regulatory authorities, including the Chinese CDE (Center for Drug Evaluation), and will request a Type C meeting with the FDA concerning their plans for Phase 3 clinical trials.

VivaVision, founded in 2016, remains committed to developing best-in-class therapies for ocular diseases. Their pipeline also includes a range of investigational treatment candidates, such as VVN001 for dry eye syndrome and VVN481, designed for posterior/pan-uveitis treatment.

This exciting progress reflects VivaVision's dedication to addressing unmet medical needs in ophthalmology. Further data from the trial will be disclosed in due course through future publications and professional conferences.

For more information on VivaVision’s initiatives and pipeline, please visit www.vivavisionbio.com.