VivaVision gets positive FDA comments for Type C Meeting Regarding VVN461LD for Post-operative Infalmmation

VivaVision gets positive FDA comments for Type C Meeting Regarding VVN461LD for Post-operative Infalmmation

By, Admin 10 June 2025

Overview

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.

FDA Supports VivaVision’s Phase 2 Trial for NDA Filing

  • FDA provided positive preliminary feedback on VivaVision’s development of VVN461LD, a dual JAK1/TYK2 inhibitor for post-operative inflammation after cataract surgery.
  • The Division of Ophthalmology (DO), Office of Specialty Medicine (OSM) agreed that VivaVision’s US Phase 2 trial (NCT06164743) may serve as one of two pivotal trials required for New Drug Application (NDA) filing.
  • VivaVision will only need one pivotal Phase 3 trial before NDA submission.
  • 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.

Statement from the CEO: VivaVision

  • 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."" 

A solution targeting specific site

  • 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.

VVN461 phase 2 trial

  • 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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