VivaVision Biotech announced positive topline results from its US Phase 2 clinical trial of VVN461-CS-201, a non-steroidal dual JAK1/TYK2 immunomodulator for the treatment of post-operative inflammation following cataract surgery.
VVN461 demonstrated statistical and clinical improvements across primary and many secondary endpoints compared to vehicle, the company said in a press release.
Key findings from the trial include:
- Primary Endpoint: At Day 14, 60.0% (18/30) (1.0%) and 53.3% (16/30) (0.5%) of subjects in the VVN461 groups achieved anterior chamber cell (ACC) Grade 0 compared to 19.4% (6/31) in the vehicle group (p=0.0012 and p=0.0057, respectively.)
- Secondary Endpoints: Clinically and statistically significant reductions in anterior chamber flare (ACF) and subject-reported ocular pain, with therapeutic effects observed as early as Day 3.
- Exploratory Findings: Over the 14 days of the study, only four subjects (combined active groups) out of 61 in the VVN461 groups required rescue medication, compared to 15 out of 30 in the vehicle group, indicating faster and more effective post-operative healing and improved baseline ocular comfort.
According to the company, the adverse event rate with both concentrations of VVN461 was low, with only mild severity, and similar to its vehicle, confirming VVN461’s safety profile.
The multicenter, randomized, double-masked, vehicle-controlled study enrolled 91 subjects who underwent routine unilateral cataract extraction by phacoemulsification and lens replacement. Subjects were randomized into three groups (VVN461 1.0%, VVN461 0.5%, and vehicle) and received four doses daily (QID) for 14 days.
Traditional corticosteroid eyedrops, while effective, are associated with adverse effects such as increased IOP, delayed wound healing, and ocular infections, particularly with long-term use. VVN461 offers a promising alternative, leveraging its targeted, non-steroidal mechanism to minimize these risks while maintaining anti-inflammatory efficacy, the company said in the release.
VivaVision is also conducting Phase 2 studies for VVN461 in non-infectious anterior uveitis in China.