- VVN461, a non-steroidal dual JAK1/TYK2 immunomodulator, achieves primary endpoint, demonstrating statistical and clinical efficacy compared to vehicle in treating post-operative inflammation following cataract surgery
- Statistically and clinically meaningful reductions in inflammation and ocular pain observed as early as Day 3
- Very favorable safety profile with low adverse event rate in active groups
The multicenter, randomized, double-masked, vehicle-controlled study enrolled 91 subjects who underwent routine unilateral cataract extraction by phacoemulsification and lens replacement (CELR). Subjects were randomized into three groups (VVN461 1.0%, VVN461 0.5%, and vehicle) and received four doses daily (QID) for 14 days. VVN461 demonstrated statistical and clinical improvements across all primary and secondary endpoints compared to vehicle.
Key findings include:
- Primary Endpoint: At Day 14, 60.0% (18/30) (1.0%) and 53.3% (16/30) (0.5%) of subjects in the VVN461 groups achieved anterior chamber cell (ACC) Grade 0 compared to 19.4% (6/31) in the vehicle group (p=0.0012 and p=0.0057, respectively.)
- Secondary Endpoints: Clinically significant reductions in anterior chamber flare (ACF) and subject-reported ocular pain, with therapeutic effects observed as early as Day 3.
- Exploratory Findings: Over the 14 days of the study, only 4 subjects (combined active groups) out of 61 in the VVN461 groups required rescue medication, compared to 15 out of 30 in the vehicle group, indicating faster and more effective post-operative healing and improved baseline ocular comfort.
"VVN461's Phase 2 results highlight its potential as a safer alternative to corticosteroids for post-operative inflammation," said Jason Bacharach, M.D., Founder and Director of Research at North Bay Eye Associates. "The positive efficacy of VVN461, combined with its excellent safety profile, addresses a critical need for anti-inflammatory therapies with fewer corticosteroid-associated risks."
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 use. VVN461 offers a promising alternative, leveraging its targeted, non-steroidal mechanism to minimize these risks while maintaining anti-inflammatory efficacy.
"VVN461 represents a meaningful step forward in ophthalmic anti-inflammatory therapy," said Dr. Wang Shen, CEO of VivaVision. "The reductions in inflammation and ocular pain observed as early as Day3, combined with a favorable safety profile, underscore the potential impact of this therapy for patients. These results provide a strong foundation to advance our efforts around a Phase 3 clinical trial of VVN461 in the U.S."
VivaVision is also conducting Phase 2 studies for VVN461 in non-infectious anterior uveitis (NIAU) in China.
About VivaVision Biotech
Founded in 2016, VivaVision Biotech is a clinical-stage pharmaceutical company dedicated to advancing best-in-class and first-in-indication therapies with additional investigational drug candidates for ocular diseases. The company's leading pipeline assets include:
- VVN461: non-steroidal dual JAK1/TYK2 immunomodulator for post-operative inflammation after cataract surgery and non-infectious anterior uveitis.
- VVN001: an investigational treatment for dry eye syndrome.
- VVN1901: a therapy targeting neurotrophic keratitis
- VVN481: a non-steroidal dual JAK1/TYK2 inhibitor for suprachoroidal delivery targeting treatment of posterior/pan-uveitis
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