VivaVision Reports Positive Phase 2 Results for VVN461 in Post-Cataract Surgery Inflammation

VVN461, a non-steroidal dual JAK1/TYK2 immunomodulator, has shown promising results in a U.S. Phase 2 clinical trial for treating post-operative inflammation following cataract surgery. The trial demonstrated that VVN461 effectively reduces inflammation and ocular pain compared to a vehicle solution.

The study, conducted by VivaVision Biotech (VivaVision), enrolled 91 patients who had undergone unilateral cataract extraction by phacoemulsification and lens replacement. Participants were divided into three groups: VVN461 1.0%, VVN461 0.5%, and a vehicle group, and received four doses daily for 14 days. The results were significant, with VVN461 showing both statistical and clinical improvements in all primary and secondary endpoints compared to the vehicle.

Key findings include the primary endpoint where, at Day 14, 60% of subjects in the VVN461 1.0% group and 53.3% in the VVN461 0.5% group achieved Grade 0 anterior chamber cell (ACC) levels, compared to 19.4% in the vehicle group. Secondary endpoints revealed significant reductions in anterior chamber flare (ACF) and reported ocular pain, with effects noted as early as Day 3.

Furthermore, exploratory findings indicated that only four subjects in the VVN461 groups required rescue medication over the 14-day period, compared to 15 in the vehicle group, suggesting more effective and quicker post-operative recovery and improved ocular comfort.

VVN461 was also found to have a very favorable safety profile. The adverse event rate was low and mild in severity, similar to the vehicle group, supporting the safety of VVN461.

Dr. Jason Bacharach, Founder and Director of Research at North Bay Eye Associates, highlighted the potential of VVN461 as a safer alternative to corticosteroids, which, although effective, can have side effects like increased intraocular pressure, delayed wound healing, and ocular infections with extended use. VVN461 offers a targeted, non-steroidal mechanism to mitigate these risks while maintaining its anti-inflammatory efficacy.

Dr. Wang Shen, CEO of VivaVision, emphasized the significance of the Phase 2 results, noting the early reductions in inflammation and ocular pain, coupled with a good safety profile. These results pave the way for a Phase 3 clinical trial in the U.S.

VivaVision is also conducting Phase 2 trials for VVN461 in non-infectious anterior uveitis (NIAU) in China. Founded in 2016, VivaVision Biotech is dedicated to developing innovative therapies for ocular diseases. Their pipeline includes VVN461 for post-operative inflammation and NIAU, VVN001 for dry eye syndrome, VVN1901 targeting neurotrophic keratitis, and VVN481, another JAK1/TYK2 inhibitor for treating posterior/pan-uveitis through suprachoroidal delivery. The company continues to explore additional therapies for anterior and posterior segment eye diseases, addressing unmet medical needs.