#China #VivaVision #Wenzhou #Uveitis #VVN461HD

Positive FDA Feedback for VivaVision Biotech's VVN461HD

VivaVision Biotech, a clinical-stage company focused on developing ophthalmic therapies, recently celebrated a significant milestone. The U.S. Food and Drug Administration (FDA) has provided written feedback from its Type C meeting regarding VVN461HD, a treatment for non-infectious anterior uveitis (NIAU). This communication reveals that the company only requires one additional Phase III clinical study in the U.S. to support its New Drug Application (NDA) for VVN461HD.

The Path to NDA Submission

Previously, VivaVision submitted a request for a Type C meeting and subsequently had a video conference with the FDA to discuss the potential of VVN461HD. The outcome of that meeting, now documented in the feedback, was increasingly optimistic. Specifically, the FDA recognized the results from an earlier Phase II clinical trial conducted by VivaVision in China. This trial is pivotal as it has been accepted as one of the essential trials for advancing towards the NDA.

According to the FDA, the ongoing Phase III study in China can be counted as one of the two required pivotal trials. As a result, VivaVision is now tasked with conducting only one Phase III clinical trial in the U.S., greatly accelerating the timeline for product development and lowering the associated R&D expenditures.

Future Expectations

With this green light from the FDA, VivaVision is set to initiate the pivotal Phase III clinical trials in the first half of 2026. Dr. Albert Tsai, Chief Medical Officer at VivaVision, expressed enthusiasm about the swift progress seen since the clinical trials for VVN461HD commenced in 2023. He noted, "These developments reflect both the execution capabilities of our team and the promising potential of this treatment. We are thankful for the FDA's recognition, which considerably reduces the time to market for this innovative therapy."

About VivaVision Biotech

Founded in 2016, VivaVision is dedicated to creating advanced therapies targeting ocular diseases. The company’s pipeline includes several promising candidates, such as:

• - VVN461LD: A dual JAK1/TYK2 inhibitor aimed at treating inflammation post-ocular surgery.
• - VVN461HD: The focus of this article, a treatment for non-infectious anterior uveitis.
• - VVN001: An experimental option for alleviating dry eye syndrome.
• - VVN1901: A therapy for neurotrophic keratitis.
• - VVN481: Focused on treating posterior/pan-uveitis and other related conditions.

VivaVision is actively pursuing solutions for both anterior and posterior segment eye diseases, addressing significant patient needs in the process. For more information, you can visit their website at www.vivavisionbio.com.

Conclusion

The future looks bright for VivaVision Biotech and its innovative drugs like VVN461HD. With positive FDA feedback and a clear path moving forward, patients suffering from non-infectious anterior uveitis may soon benefit from cutting-edge treatments that could enhance their quality of life significantly.