• VVN461, a dual JAK1/TYK2 inhibitor as a non-steroidal anti-inflammatory agent, has met primary endpoints, demonstrating non-inferior efficacy compared to the standard therapy, prednisolone acetate (PA) in treating NIAU
• Clinically meaningful reductions in inflammation compared to baseline observed as early as Day 3
• Strong safety profile with no substantial treatment-related adverse events reported

WENZHOU, China, April 25, 2025 /PRNewswire/ -- VivaVision Biotech (VivaVision), a clinical-stage, privately held biotechnology company focused on developing innovative treatments for ocular diseases, 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.

This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at 10 clinical sites in China enrolling 86 subjects with NIAU. 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.

Both VVN461 dose groups demonstrated statistically significant and clinically meaningful improvements from baseline across most primary and secondary endpoints. The efficacy of VVN461 groups were comparable to prednisolone acetate group. No substantial treatment-related adverse events were reported, confirming VVN461's excellent safety profile.

Full data will be reported in future publications in conferences and journals.

"I am very pleased to see that VVN461 showed non-inferior efficacy to prednisolone acetate in the phase 2 clinical trial for NIAU in China. This is a very significant and potentially disruptive progress in treating uveitis." said Professor. Liu Yang, Director of Ophthalmology at Peking University First Hospital, "We hope that this safe, highly efficacious and accessible non-steroidal medicine, VVN461 would be available to benefit patients in near future."

Uveitis is the inflammation of uvea which consists of the iris, ciliary body, and choroid. Uveitis affects approximately 3 million patients in China with ~60% classified as NIAU. Uveitis may recur and be chronic, and it is a leading cause of vision loss accounting 10–20% of cases of acquired legal blindness. Treatment of NIAU typically involves the use of topical steroids, which are associated with adverse effects such as increased intraocular pressure, delayed wound healing, and ocular infections. Repeated or chronic use of topical steroids may lead to severe side effects, such as ocular hypertension and cataract. Therefore, the effective control of uveitis inflammation with minimization of side effects is critically needed. VVN461 offers a promising alternative, leveraging its targeted, non-steroidal mechanism to minimize these risks while maintaining anti-inflammatory efficacy.

 VivaVision has scheduled a discussion with Chinese CDE and is planning to request a type C meeting with FDA about phase 3 clinical trials.

About VivaVision Biotech

Founded in 2016, VivaVision Biotech is a clinical-stage pharmaceutical company dedicated to advancing best-in-class therapies with additional investigational drug candidates for ocular diseases. The company's leading pipeline assets include:

• VVN461: a 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 for targeting neurotrophic keratitis
• VVN481:  a non-steroidal dual JAK1/TYK2 inhibitor for suprachoroidal delivery to treat posterior/pan-uveitis and posterior inflammatory diseases
• VVN432: a non-steroidal JAK inhibitor nasal spray for chronic rhinosinusitis (CRS)

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.

China Media Contact
Ruby SUN
Phone: +86 181-1619-2461
Email: yanyan.sun@vivavisionbio.com

Source: VivaVision Biotech