VVN461 is a non-steroidal dual JAK1/TYK2 immunomodulator, which works by inhibiting multiple inflammatory cytokine pathways thereby reducing inflammation. Image Credit: Aleksandr Rybalko / Shutterstock.

China-headquartered VivaVision Biotech is looking to advance its non-steroidal therapy, VVN461-CS-201 (VVN461), in a Phase III trial after the candidate met the primary endpoint in a Phase II US study evaluating the treatment of post-operative inflammation following cataract surgery.

The company’s CEO Wang Shen touted the Phase II trial (NCT06164743) results noting that the therapy caused “reductions in inflammation and ocular pain observed as early as day three”. Adding that the “results provide a strong foundation to advance our efforts around a Phase III clinical trial of VVN461 in the US”.

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Corticosteroids are commonly used to manage inflammation post-surgery. However, the long-term use of steroids can have side effects ranging from withdrawal syndrome and mood changes to elevated blood pressure or blood sugar levels, infections, and gastrointestinal symptoms. VVN461 is a non-steroidal dual JAK1/TYK2 immunomodulator, which works by inhibiting multiple inflammatory cytokine pathways thereby reducing inflammation.

The Phase II trial enrolled 91 participants who underwent routine unilateral cataract extraction by phacoemulsification and lens replacement (CELR). The participants were randomised into three groups to receive either of the two doses of VVN461, 1% and 0.5%, or vehicle control.

The study met its primary endpoint of 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 the participants receiving VVN461 1% and 0.5% scored anterior chamber cell (ACC) Grade 0, compared to 19.4% in the vehicle group.

The therapy also showed clinically significant reductions in anterior chamber flare (ACF) and subject-reported ocular pain, the trial’s secondary endpoints. VivaVision noted that only four out of 61 participants in the two VVN461 groups required rescue medication compared to 15 out of 30 in the vehicle group, which the company attributed to faster and more effective post-operative healing and improved baseline ocular comfort achieved by VVN461.

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VivaVision is also investigating VVN461 as a treatment for non-infectious anterior uveitis, another ocular inflammatory condition. The company is conducting a Phase II trial (NCT06679153) in this indication in China and is currently recruiting participants for the study.

VivaVision’s portfolio of eye therapies also includes dry eye treatment VVN001, VVN1901 for neurotrophic keratitis, and non-steroidal dual JAK1/TYK2 inhibitor VVN481 for suprachoroidal delivery targeting treatment of posterior/pan-uveitis.