VivaVision Biotech Announces Positive Phase 2 Results for VVN461 Ophthalmic Solution in Non-Infectious Anterior Uveitis

Jan 03, 2025 16:01 CST Updated 16:01

VIVAVISION

Innovative Drug Developer

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. Both dose groups achieved non-inferiority to the positive control 1% prednisolone acetate ophthalmic solution in terms of the primary efficacy endpoint and secondary endpoints, with statistical significance.

Anterior Uveitis: The Most Common Type with Limited Treatment Options

This multi-center, double-blind, randomized, positive-controlled Phase II clinical trial aims to evaluate the efficacy and safety of VVN461 in patients with non-infectious anterior uveitis.This study enrolled 8 participants across 10 clinical centers in China.Six subjects were randomly assigned to the 0.5% VVN461 group, 1% VVN461 group, and 1% prednisolone acetate eye drops group.

The primary efficacy endpoint of this study was the proportion of participants with a ≥2-grade improvement in the anterior chamber cell count (ACC) score from baseline at Day 14 post-treatment.Topline data showed that at 14 days post-treatment, 93% (25/27) of subjects in the 0.5% VVN461 group, 97% (28/29) in the 1.0% group, and 78% (21/27) in the 1% prednisolone acetate ophthalmic solution group reached the primary efficacy endpoint.Both doses of VVN461 statistically achieved non-inferiority compared to 1% prednisolone acetate ophthalmic solution.

Additionally, in the observation of key secondary endpoints at 14 days post-treatment, 48% (13/27) of subjects in the 0.5% VVN461 group reached ACC Grade 0, 62% (18/29) in the 1.0% group reached ACC Grade 0, and 41% (11/27) in the 1% prednisolone acetate ophthalmic solution group reached ACC Grade 0. The efficacy of both doses of VVN461 was non-inferior to that of 1% prednisolone acetate ophthalmic solution. Moreover, VVN461 also demonstrated similarly significant efficacy in reducing anterior chamber flare.

While demonstrating the above significant efficacy, the proportion of drug-related side effects observed in this study was low, all of which were mild to moderate and did not require drug intervention. No significant drug-related adverse events were observed in the study. The success of this clinical trial further validates the safety and efficacy of VVN461, which is expected to become a new treatment option for uveitis after its market launch.

Professor Liu Yang

Director of the Ophthalmology Center, Peking University First Hospital

Very pleased to see the excellent results achieved by VVN461 in the Chinese Phase II clinical trial for anterior uveitis. The study shows that VVN461 eye drops have demonstrated non-inferior efficacy compared to glucocorticoids in treating anterior uveitis, which is a groundbreaking advancement in the field of uveitis. We hope that the safe, innovative, and accessible non-steroidal anti-inflammatory VVN461 eye drops can be launched soon to bring greater benefits to patients.

Dr. Shen Wang

Founder and Chief Executive Officer of VIVAVISION

VIVAVISION's mission is to bring the best and revolutionary treatment options to patients with ophthalmic diseases in China and globally. VVN461 has shown excellent results in the Phase 2 clinical trial for non-infectious anterior uveitis in China. In the first quarter of this year, we will discuss with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China and the U.S. FDA to advance VVN461 into pivotal Phase 3 clinical trials in both China and the United States, aiming to bring this drug to market as soon as possible. We look forward to providing uveitis patients, who currently rely solely on steroid treatments, with a non-steroidal drug that offers equally effective (or even better) efficacy and minimal (or no) side effects, benefiting patients.

About VVN461

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 the use of the company’s proprietary technology platform, "Flash Transmucosal Drug Delivery System (FTDS)," to develop advanced complex formulations. Results from human pharmacokinetic studies show that VVN461 eye drops have low plasma exposure, indicating that while exerting localized anti-inflammatory effects, VVN461 eye drops exhibit low systemic toxicity and high safety.

About VIVAVISION

VIVAVISION is a clinical-stage innovative drug company focused on the field of ophthalmic treatment. The company was founded by a team of world-class ophthalmic drug development experts and has established a unique platform for ophthalmic innovative drug research and development. Several innovative drug products independently developed by the company have entered or are about to enter the clinical stage.

For more information, please visit: www.vivavisionbio.com

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