VivaVision Announces VVN461 Meets Primary and Secondary Endpoints in U.S. Phase 2 Trial for Post-Cataract Surgery Inflammation

VVN461 is a "First-in-Class" innovative non-steroidal anti-inflammatory eye drop independently developed by VIVAVISION. In this clinical trial, it demonstrated excellent anti-inflammatory effects, with both dose groups showing statistical significance 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 associated with numerous side effect risks, such as increased intraocular pressure, heightened risk of cataracts, delayed corneal epithelial repair and wound healing, corneal stromal melting, and even corneal ulcers or perforations. For patients on long-term chronic medication, these issues are particularly prominent, representing significant unmet clinical needs.

However, the anti-inflammatory effect of cyclooxygenase (COX) inhibitor non-steroidal anti-inflammatory drugs (NSAIDs) is not strong enough, and there are occasional severe side effects such as corneal melting. Therefore, developing a new type of anti-inflammatory drug that has an anti-inflammatory effect comparable to steroids while maintaining high safety and avoiding steroid-related side effects has become a potential breakthrough in the field of ophthalmic innovative drugs.

VVN461 is a groundbreaking innovation in the global application of JAK inhibitors in the field of ophthalmic anti-inflammation. It is a fourth-generation small molecule inhibitor with high activity and high selectivity for dual targets JAK1/TYK2. It operates through a clear anti-inflammatory mechanism and leverages VIVAVISION's proprietary technology platform, the "Fast Transient Delivery System" (FTDS).The developed high-end complex formulation achieves efficient delivery and excellent therapeutic effects on the ocular surface.

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 undergoing routine unilateral cataract surgery. The study enrolled 91 subjects across 10 clinical sites in the United States, who were 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, while only 19.4% (6/31) in the vehicle group reached ACC grade 0. Both dose groups demonstrated significant clinical and statistical significance compared to the vehicle group (p=0.0012 and p=0.0057). Additionally, for secondary and exploratory endpoints, the treatment groups showed significant efficacy in reducing anterior chamber flare and relieving pain.

No significant adverse events related to the treatment were observed in this study, while the aforementioned remarkable efficacy was demonstrated.The success of this clinical trial further validates the safety and efficacy of VVN461.In the future, after VVN461 is launched, it is expected to become a new choice for the treatment of inflammation following various ophthalmic surgeries.

VIVAVISION is currently conducting a Phase II clinical trial in China to evaluate VVN461 for the treatment of non-infectious anterior uveitis. Increasing evidence suggests that the JAK-STAT signaling pathway is crucial for inflammation and immune responses. VVN461 can potently inhibit multiple inflammatory cytokine pathways, and VIVAVISION is exploring the potential use of VVN461 in treating various ocular inflammatory diseases.