VivaVision Biotech's non-steroidal therapy, VVN461-CS-201 (VVN461), has shown positive results in a Phase II clinical trial for treating post-operative inflammation following cataract surgery, potentially paving the way for a Phase III trial in the US. The study (NCT06164743) demonstrated that VVN461 met its primary endpoint, with significant reductions in inflammation and ocular pain observed as early as day three.
VVN461: A Non-Steroidal Alternative
Corticosteroids are commonly used post-surgery to manage inflammation, but their long-term use can lead to side effects such as withdrawal syndrome, mood changes, elevated blood pressure, infections, and gastrointestinal symptoms. VVN461, a non-steroidal dual JAK1/TYK2 immunomodulator, inhibits multiple inflammatory cytokine pathways, offering a potentially safer alternative.
Phase II Trial Results
The Phase II trial enrolled 91 participants undergoing routine unilateral cataract extraction with phacoemulsification and lens replacement (CELR). Participants were randomized into three groups, receiving either VVN461 1%, VVN461 0.5%, or a vehicle control, administered four times daily (QID) over 14 days.
The primary endpoint was achieving an anterior chamber cell (ACC) Grade 0, a measure of inflammation based on the number of visible cells viewed through a slit lamp. On day 14, 60.0% and 53.3% of participants receiving VVN461 1% and 0.5%, respectively, scored ACC Grade 0, compared to 19.4% in the vehicle group (p=0.0012 and p=0.0057, respectively).
The therapy also demonstrated clinically significant reductions in anterior chamber flare (ACF) and subject-reported ocular pain, which were secondary endpoints of the trial. Only four participants in the combined VVN461 groups required rescue medication, compared to 15 in the vehicle group, suggesting faster and more effective post-operative healing.
Safety Profile
The adverse event rate with both concentrations of VVN461 was low and similar to the vehicle, confirming its favorable safety profile.
Expert Commentary
"VVN461’s Phase 2 results highlight its potential as a safer alternative to corticosteroids for post-operative inflammation," said Jason Bacharach, MD, Founder and Director of Research at North Bay Eye Associates. "The positive efficacy of VVN461, combined with its excellent safety profile, addresses a critical need for anti-inflammatory therapies with fewer corticosteroid-associated risks."
Ongoing Research
VivaVision is also investigating VVN461 as a treatment for non-infectious anterior uveitis, another ocular inflammatory condition, in a Phase II trial (NCT06679153) in China.
VivaVision's Broader Portfolio
VivaVision’s portfolio includes other eye therapies such as VVN001 for dry eye disease, VVN1901 for neurotrophic keratitis, and VVN481, a non-steroidal dual JAK1/TYK2 inhibitor for suprachoroidal delivery targeting posterior/pan-uveitis.
