Chinese clinical-stage biotechnology company VivaVision Biotech on Tuesday reported positive topline results from its US Phase 2 clinical trial of VVN461-CS-201, a potent non-steroidal dual JAK1/TYK2 immunomodulator intended for the treatment of post-operative inflammation following cataract surgery.

The multicentre, randomised, double-masked, vehicle-controlled study enrolled 91 people who underwent routine unilateral cataract extraction by phacoemulsification and lens replacement (CELR). Subjects were randomised into three groups (VVN461 1.0%, VVN461 0.5% and vehicle) and received four doses daily (QID) for 14 days. VVN461 demonstrated statistical and clinical improvements across all primary and secondary endpoints compared to vehicle.

In the primary endpoint of the study, at day 14, 60% (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. Secondary endpoints showed a clinically significant decrease in anterior chamber flare (ACF) and subject-reported ocular pain, with therapeutic impacts seen as early as Day 3. During the 14 days of the study, only four subjects (combined active groups) out of 61 in the VVN461 groups needed rescue medication, compared to 15 out of 30 in the vehicle group, demonstrating faster and more effective post-operative healing and improved baseline ocular comfort. The adverse event rate with both concentrations of the product was low, with only mild severity, and similar to its vehicle, confirming the product's safety profile.

The company is also carrying out Phase 2 studies for the product in non-infectious anterior uveitis (NIAU) in China.