#China #VivaVision #VVN461 #cataract surgery #Wenzhou

Introduction

VivaVision Biotech has made significant strides in ocular therapy with the announcement of positive topline results from its Phase 2 clinical trial for VVN461, a dual JAK1/TYK2 immunomodulator designed to alleviate post-operative inflammation following cataract surgery. Conducted across multiple centers, this randomized, double-masked, vehicle-controlled study involved 91 participants who received varying concentrations of VVN461 over a 14-day period.

Study Overview

The trial divided participants into three groups: one receiving VVN461 at 1.0%, another at 0.5%, and a control group receiving a vehicle. Each participant underwent standard unilateral cataract extraction and was monitored for inflammation and ocular pain, crucial indicators of recovery in such procedures. The results showcased that VVN461 not only met but exceeded expectations for both primary and secondary endpoints, establishing its potential in ophthalmic treatments.

Key Findings

Among the critical findings were:

• - Primary Endpoint: At Day 14, 60% of subjects on VVN461 1.0% and 53% on VVN461 0.5% reached an anterior chamber cell (ACC) grade of 0, compared to just 19.4% in the vehicle group, indicating significant reduction in inflammation (p=0.0012 for 1.0% and p=0.0057 for 0.5%).
• - Secondary Endpoints: Participants reported noteworthy reductions in anterior chamber flare and ocular pain, with therapeutic effects seen as soon as Day 3.
• - Rescue Medication Use: Only four out of 61 patients receiving VVN461 required additional rescue medications, starkly contrasting with 15 out of 30 in the vehicle group, implying faster healing and improved comfort levels.

Safety Profile

One of the standout features of VVN461 was its safety profile. The rate of adverse events was notably low across both dosages, aligning with the vehicle group and indicating that the medication has a favorable safety margin. Dr. Jason Bacharach highlighted the urgent need for alternatives to traditional corticosteroid therapies, which often come with serious side effects including increased intraocular pressure and infection risks.

Potential Advantages

VVN461 presents a compelling alternative to corticosteroids, maintaining effective anti-inflammatory properties while minimizing risks associated with long-term steroid use. This attribute alone could revolutionize post-operative care in ophthalmology, offering a treatment path that patients can trust for both efficacy and safety.

Looking Ahead

Dr. Wang Shen, CEO of VivaVision, expressed optimism, stating that the positive outcomes not only pave the way for a Phase 3 clinical trial in the U.S. but also underline the importance of VVN461 in the evolution of anti-inflammatory therapy in ophthalmology. Furthermore, the company is concurrently pursuing Phase 2 studies for VVN461 in non-infectious anterior uveitis in China, broadening its therapeutic potential.

Conclusion

VivaVision Biotech’s commitment to advancing ocular therapies is underscored by the promising results of VVN461. The initial findings empower the company to push forward in clinical development aimed at addressing significant gaps in patient need within ocular care. With its innovative approach and proven effectiveness, VVN461 stands as a crucial step forward, redefining how post-cataract surgery inflammation can be managed for better long-term patient outcomes.

For further information on VivaVision’s significant innovations in ocular care, visit VivaVision Biotech.