A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis

A Randomized, Double-masked, Active-controlled, Multi-center Phase 2 Clinical Study Evaluating the Efficacy and Safety of 0.5% and 1.0% VVN461 Ophthalmic Solution in Patients With Noninfectious Anterior Uveitis

This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis

In this study, subjects who meet the inclusion/exclusion criteria will be randomized to receive one of the three treatments prednisolone acetate during the Screening/Baseline Visit (Day-2 to Day 1). Starting from Visit 1 (Day 1), subjects will be administered one drop of the investigational product in the study eye in following dose regimens: 6 times per day (Q2h, 2 hours apart) for 7 days; 4 times per day (QID) for 7 days；2 times per day (BID) for 7 days；once a day (QD) for 7 days. Subjects will return to clinic for study assessments on Day 3 (Visit 2), Day 7 (Visit 3), Day 14 (Visit 4), Day 21 (Visit 5) and Day 28 (Visit 6, end of study) or early withdrawal/termination visit.

Inclusion Criteria:

• Age 18-70 years at the time providing signed informed consent
• At least 1 eye diagnosed with noninfectious anterior uveitis at the time of screening
• Willing and able to comply with study requirements and visit schedule

Exclusion Criteria:

• Diagnosis of intermediate uveitis, posterior uveitis or panuveitis in either eye at the time of screening