VivaVision Announces Positive Topline Results from Phase 2 Trial of VVN461 for Post-Operative Inflammation Following Cataract Surgery

• 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

WENZHOU, China and SAN DIEGO, Dec. 4, 2024 /PRNewswire/ -- VivaVision Biotech (VivaVision), a clinical-stage, privately held biotechnology company focused on developing treatments for ocular diseases, today announced positive topline results from its U.S. Phase 2 clinical trial of VVN461-CS-201, a potent non-steroidal dual JAK1/TYK2 immunomodulator for the treatment of post-operative inflammation following cataract surgery.

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.

The adverse event rate with both concentrations of VVN461 was low, with only mild severity, and similar to its vehicle, confirming VVN461's safety profile.

"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

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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