VivaVision Biotech Receives Positive Written Feedback from FDA - VVN461HD New Drug Application (NDA) Requires Only a "Single Phase III" Pivotal Clinical Study in the U.S. for Non-Infectious Anterior Uveitis Treatment

WENZHOU, China, Jan. 6, 2026 /PRNewswire/ -- Recently, VivaVision Biotech (VivaVision), a late clinical-stage, privately-held biotech company focused on developing innovative ophthalmic drugs, announced that it has received the written meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Type C meeting discussion for VVN461HD for the treatment of non-infectious anterior uveitis (NIAU). The minutes confirm that the ongoing Phase III clinical study in China can serve as one of the two pivotal trials required to support a future New Drug Application (NDA) for VVN461HD targeting this indication.

Previously, VivaVision Biotech had submitted a Type C meeting application and held a video conference call with the FDA to discuss VVN461HD for the treatment of non-infectious anterior uveitis. Recently, the company obtained the official meeting minutes from the FDA in response to this meeting. The feedback indicates that the FDA positively acknowledged the results of the Phase II clinical trial of VVN461HD for non-infectious anterior uveitis completed by VivaVision Biotech in China, reached an agreement with the company on the design of the next Phase III clinical studies, and agreed to recognize the Phase III clinical trial conducted in China as one of the two pivotal trials required for the subsequent NDA. 

Based on this feedback, VivaVision Biotech only needs to conduct one pivotal Phase III clinical trial in the United States before submitting the NDA, which will significantly shorten the development timeline and reduce R&D investment for this product. 

The positive response from the FDA has provided a clear pathway for VivaVision to advance the clinical development of VVN461HD for the treatment of noninfectious anterior uveitis. The company expects to initiate the Phase III clinical trial in the United States in the first half of 2026.

Dr. Albert Tsai

[Chief Medical Officer, VivaVision Biotech] 

"Since the initiation of clinical trials for VVN461HD in 2023, it has demonstrated rapid clinical progress and excellent efficacy, reflecting the clinical development and execution capabilities of the VivaVision team. We look forward to achieving more breakthroughs with ophthalmology drugs represented by VVN461HD in the future. At the same time, we are very grateful for the FDA's recognition of the Phase II clinical trial of VVN461HD conducted in China, which signifies a significant reduction in the pre-market development timeline for this product."

About VivaVision Biotech

Founded in 2016, VivaVision Biotech is a late clinical-stage biopharmaceutical company dedicated to advancing first/best-in-class therapies for ocular diseases. The company's leading pipeline assets include:

• VVN461LD: a dual JAK1/TYK2 inhibitor for the treatment of post-operative inflammation following ocular surgery. (LD denotes "low-dose")
• VVN461HD: a dual JAK1/TYK2 inhibitor for the treatment of non-infectious anterior uveitis. (HD denotes "how-dose")
• VVN001: an investigational treatment for dry eye syndrome.
• VVN1901: a therapy to treat neurotrophic keratitis
• VVN481: a dual JAK1/TYK2 inhibitor for suprachoroidal delivery targeting treatment of posterior/pan-uveitis and posterior inflammatory diseases

In addition to its pipeline, VivaVision is actively engaged in the discovery and development of additional therapies for anterior and posterior segment eye diseases to address unmet patient needs. For more information, please visit www.vivavisionbio.com.

SOURCE VivaVision Biotech