VVN461 / VivaVision - LARVOL DELTA

A randomized, single-blind, positive-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of 1.0% VVN461 eye drops in patients with non-infectious anterior uveitis (ChiCTR) - P3 | N=152 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Chongqing Medical University

New P3 trial • Ocular Inflammation • Ophthalmology • Uveitis

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 (Yahoo Finance) - "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...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 company expects to initiate the Phase III clinical trial in the United States in the first half of 2026."

FDA event • New P3 trial • Uveitis

VVN461 Solution in Patients with Acute Noninfectious Anterior Uveitis. (PubMed, Ophthalmology) - No abstract available

Journal • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis (clinicaltrials.gov) - P3 | N=152 | Not yet recruiting | Sponsor: VivaVision Biotech, Inc

New P3 trial • Ocular Inflammation • Ophthalmology • Uveitis

Double-Masked, Dose-Response, Vehicle-Controlled Study of VVN461 Ophthalmic Solution in Postoperative Ocular Inflammation. (PubMed, Ophthalmol Sci) - "In this double-masked, vehicle-controlled study, clinically and statistically significant anti-inflammatory efficacy was seen with few safety issues. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

Journal • Cataract • Inflammation • Ocular Inflammation • Ophthalmology

VivaVision Announces Positive Topline Results from Phase 2 Trial of VVN461 for Non-Infectious Anterior Uveitis (PRNewswire) - P2 | N=89 | NCT06679153 | Sponsor: VivaVision Biotech, Inc | "VivaVision Biotech...today announced positive topline results from its phase 2 clinical trial of VVN461, a potent dual JAK1/TYK2 inhibitor for the treatment of Non-Infectious Anterior Uveitis (NIAU) in China....Subjects were randomized into three groups (VVN461-1.0%, VVN461-0.5%, and prednisolone acetate-1.0%) and received treatments for 28 days. Prednisolone acetate is the first-line corticosteroid therapy for NIAU. Both 0.5% and 1% of VVN461 ophthalmic solutions showed non-inferior efficacy compared to active control PA for its primary endpoint: subjects treated with VVN461 had 2 step decrease in ACC grade vs. subjects treated with prednisolone acetate (p <0.001). Note: ACC (anterior chamber cells) were evaluated using SUN grading scale....Full data will be reported in future publications in conferences and journals."

P2 data • Ophthalmology • Uveitis

Pharmacokinetics of VVN461 Ophthalmic Solution (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: VivaVision Biotech, Inc

New P1 trial • Ophthalmology

A phase 2, double-masked, randomized, vehicle-controlled study of VVN461 Ophthalmic Solution in treating post-operative ocular inflammation in subjects undergoing routine unilateral cataract surgery (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P2 data • Surgery • Cataract • Ocular Inflammation • Ophthalmology • JAK1 • TYK2

Ocular pharmacokinetics and tolerability of VVN481, a novel JAK inhibitor, following suprachoroidal delivery in rabbits (ARVO 2025) - "VVN481, a prodrug of a highly potent and selective JAK1/TYK2 inhibitor VVN461, is formulated as a suspension for suprachoroidal injection using the Everads proprietary injector (Everads Therapy,Fig...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

PK/PD data • Preclinical • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis • JAK1 • TYK2

High ocular and low systemic exposure of topical VVN461, a First-in-class Topical JAK inhibitor targeting ocular inflammation (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Cataract • Ocular Inflammation • Ophthalmology • Uveitis • JAK1 • TYK2

A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis (clinicaltrials.gov) - P2 | N=89 | Completed | Sponsor: VivaVision Biotech, Inc | Terminated ➔ Completed

Trial completion • Ocular Inflammation • Ophthalmology • Uveitis

A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis (clinicaltrials.gov) - P2 | N=89 | Terminated | Sponsor: VivaVision Biotech, Inc | Trial completion date: Mar 2025 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2025 ➔ Dec 2024

Trial completion date • Trial primary completion date • Trial termination • Ocular Inflammation • Ophthalmology • Uveitis

A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: VivaVision Biotech, Inc

New P2 trial • Ocular Inflammation • Ophthalmology • Uveitis

Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery (clinicaltrials.gov) - P2 | N=91 | Completed | Sponsor: VivaVision Biotech, Inc | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ May 2024 | Trial primary completion date: Dec 2024 ➔ May 2024

Surgery • Trial completion • Trial completion date • Trial primary completion date • Cataract • Inflammation • Ocular Inflammation • Ophthalmology

Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: VivaVision Biotech, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Cataract • Inflammation • Ocular Inflammation • Ophthalmology

Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: VivaVision Biotech, Inc

New P2 trial • Cataract • Inflammation • Ocular Inflammation • Ophthalmology