VivaVision Announces Positive Comments from FDA for the Type C Meeting Regarding VVN461LD for Post-operative Infalmmation - Agreeing the Phase 2 Trial to Be Served as One of the Two Pivotal Studies.

, /PRNewswire/ -- VivaVision Biotech (VivaVision), a late clinical-stage, privately-held biotech company focused on developing innovative ophthalmic drugs, announced today that it received written preliminary comments for the Type C meeting to be held in early June, 2025 with the United States Food and Drug Administration (FDA).  A Type C meeting is a formal meeting with the FDA requested by a sponsor regarding the development and review of a product.

The FDA's preliminary comments were positive regarding the questions that VivaVision prepared for the development of VVN461LD, a potent dual JAK1/TYK2 inhibitor for the treatment of post-operative inflammation following cataract surgery. Most importantly, the Division of Ophthalmology (DO), Office of Specialty Medicine (OSM) at FDA agreed with VivaVision that its US phase 2 trial (NCT06164743) may serve as one of the two pivotal trials required for NDA filing of VVN461LD as treatment for ocular post-operative inflammation. Therefore, VivaVision will need to run only one pivotal phase 3 trial before NDA filing. The US phase 2 study of VVN461 has been published on Ophthalmology Science (https://www.ophthalmologyscience.org/article/S2666-9145(25)00104-6/fulltext).

The productive preliminary comments have provided the Company a clear path forward in the US to develop VVN461LD for the treatment of ocular post-operative inflammation; therefore, a formal meeting is no longer necessary and is subsequently canceled.

"VVN461 is positioned to be a safer but equally effective alternative to ocular corticosteroids, a highly meaningful advancement in ocular anti-inflammatory therapies for the patients," said Dr. Wang Shen, CEO of VivaVision. "These positive comments from the FDA recognized VVN461's potential as an excellent ocular anti-inflammatory drug, and it also significantly shortens the time before patients in need can use the drug." 

Traditional corticosteroid eye drops, while effective, are associated with adverse effects such as increased intraocular pressure, delayed wound healing, and ocular infections, particularly with long-term or repeated use. VVN461 offers a promising alternative, leveraging its targeted, non-steroidal mechanism to minimize these side effects while maintaining similar anti-inflammatory efficacy.

The US phase 2 trial of VVN461 was partly supported by grants from the Clinical Translational Catalyst (CTC) program of the Hong Kong Science and Technology Parks Corporation (HKSTP). The CTC program is managed by the HKSTP Life and Health Technology, and the overarching aim is to provide a platform to transform Hong Kong and the Greater Bay Area into a go-to destination for translational medicine in the region. Under this program, funding support will be provided to biomedical companies of HKSTP to bring innovative, life-changing therapies and technologies to patients. The Company appreciates the great support from HKSTP team and the funding received from HKSTP CTC program in 2023 specifically for this trial.

VivaVision is also planning to discuss with the Chinese CDE, and will initiate phase 3 clinical trials in both the US and China in the near future.

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.
• VVN461HD: a dual JAK1/TYK2 inhibitor for the treatment of non-infectious anterior uveitis.
• 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.

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SOURCE VivaVision Biotech