Wenzhou, China - VIVAVISION announced that its self-developed innovative drug VVN461 met the primary and secondary endpoints in the U.S. Phase II clinical trial for treating post-cataract surgery inflammation.
VVN461 is a First-in-class innovative non-steroidal anti-inflammatory eye drop independently developed by VIVAVISION, demonstrating excellent anti-inflammatory effects in this clinical trial. Both dosage groups achieved statistically significant results compared to the vehicle control across all primary and secondary endpoints.For a long time, corticosteroid eye drops have been the first-line medication for ophthalmic anti-inflammatory treatment. However, the use of corticosteroids is accompanied by numerous side effect risks, such as increased intraocular pressure, elevated risk of cataracts, delayed corneal epithelial repair and wound healing, corneal stromal melting, and even corneal ulcers or perforations. For patients requiring long-term chronic medication, these issues are particularly prominent, representing a significant unmet clinical need. Meanwhile, cyclooxygenase (COX) inhibitor non-steroidal anti-inflammatory drugs (NSAIDs) exhibit insufficient anti-inflammatory effects and occasionally cause severe side effects like corneal melting. Therefore, developing a new type of anti-inflammatory drug that matches the efficacy of corticosteroids while maintaining high safety and avoiding corticosteroid-related side effects has become a potential breakthrough in the field of innovative ophthalmic drugs.VVN461 is a non-steroidal targeted anti-inflammatory innovative drug independently developed by VIVAVISION. It also represents the world's first breakthrough innovation in applying JAK inhibitors to the field of ophthalmic anti-inflammation. As a fourth-generation small molecule inhibitor with high activity and high selectivity targeting both JAK1 and TYK2, it achieves efficient delivery and excellent therapeutic effects on the ocular surface through a clear anti-inflammatory mechanism and by leveraging the company’s proprietary technology platform, the "Fast Transdermal Drug Delivery System (FTDS)," to develop advanced complex formulations.This multi-center, double-blind, randomized, vehicle-controlled Phase II clinical trial aims to evaluate the safety and efficacy of VVN461 in treating postoperative inflammation in patients who have undergone routine unilateral cataract surgery. This study enrolled 91 subjects across 10 clinical centers in the United States, randomly assigned to the VVN461 1% group, VVN461 0.5% group, or the vehicle group.The primary efficacy endpoint of this study was the proportion of subjects with grade 0 anterior chamber cells (ACC) in the eye on day 14. Topline data showed that at 14 days post-treatment, 60.0% (18/30) of subjects in the VVN461 1% group reached ACC grade 0, 53.3% (16/30) in the 0.5% group reached ACC grade 0, compared to only 19.4% (6/31) in the vehicle group. Both dose groups demonstrated significant clinical and statistical improvements over the vehicle group (p=0.0012 and p=0.0057). Additionally, in terms of secondary and exploratory endpoints, the treatment groups showed significant efficacy in reducing anterior chamber flare and alleviating pain.No significant treatment-related adverse events were observed in this study, while the aforementioned remarkable efficacy was demonstrated. The success of this clinical trial further validates the safety and effectiveness of VVN461, which is expected to become a new option for the treatment of inflammation after various ophthalmic surgeries upon its future market launch.VIVAVISION is currently conducting a Phase II clinical trial in China for VVN461 in the treatment of non-infectious anterior uveitis. Increasing evidence suggests that the JAK-STAT signaling pathway is crucial for inflammation and immune response. VVN461 can highly inhibit multiple inflammatory cytokine pathways, and VIVAVISION is exploring the potential of using VVN461 to treat more ocular inflammatory diseases.
About VVN461
VVN461 is a potent small-molecule immunomodulator independently developed by VIVAVISION. It exhibits high activity in inhibiting multiple cytokine pathways, thereby reducing and alleviating inflammatory responses in the eye. Results from human pharmacokinetic studies indicate that VVN461 eye drops have low plasma exposure, suggesting that while exerting local anti-inflammatory effects, VVN461 eye drops present low systemic toxicity and high safety.
