/PRNewswire/ -- VivaVision Biotech (VivaVision), a clinical-stage, privately held biotechnology company focused on developing

/PRNewswire/ -- VivaVision Biotech（VivaVision），一家临床阶段的私营生物技术公司，专注于开发

innovative

创新的

treatments for ocular diseases, today announced positive topline results from its phase 2 clinical trial of VVN461, a potent

眼部疾病治疗，今天宣布了其VVN461二期临床试验的积极顶线结果，VVN461是一种强效的

dual JAK1/TYK2

双JAK1/TYK2

inhibitor for the treatment of Non-Infectious Anterior Uveitis (NIAU) in

用于治疗非感染性前葡萄膜炎（NIAU）的抑制剂

This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at 10 clinical sites in

这是一项在10个临床站点进行的多中心、双盲、随机、活性对照、平行比较研究

enrolling 86 subjects with NIAU. Subjects were randomized into three groups (

纳入86名NIAU受试者。受试者被随机分为三组 (

VVN461-1.0%, VVN461-0.5%, and prednisolone acetate-1.0%

VVN461-1.0%、VVN461-0.5% 和 醋酸泼尼松龙-1.0%

) and received treatments for 28 days.

）并接受了28天的治疗。

Prednisolone acetate is the first-line corticosteroid therapy for NIAU.

醋酸泼尼松龙是NIAU的一线皮质类固醇疗法。

Both 0.5% and 1% of VVN461 ophthalmic

VVN461 眼科用 0.5% 和 1%

solutions

解决方案

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.

对于主要终点，与活性对照PA相比，显示出非劣效性：接受VVN461治疗的受试者在ACC等级上有2级下降，而接受醋酸泼尼松龙治疗的受试者则没有（p <0.001）。注意：ACC（前房细胞）使用SUN分级量表评估。

Both VVN461 dose groups demonstrated statistically significant and clinically meaningful

两个VVN461剂量组均显示出统计学上显著且临床意义上重要的结果

improvements from baseline across

比基线的改进

most primary

最基础的

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.

和次要终点。VVN461组的疗效与醋酸泼尼松龙组相当。未报告显著的治疗相关不良事件，证实了VVN461的优异安全性。

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

完整数据将在未来的会议和期刊发表中报告。

'I am very pleased to see that VVN461 showed non-inferior efficacy to prednisolone acetate in the phase 2 clinical trial for NIAU in

“我很高兴看到VVN461在NIAU的二期临床试验中显示出不劣于醋酸泼尼松龙的疗效。

China

中国

. This is a very significant and potentially disruptive progress in treating uveitis.' said Professor.

。这是一个治疗葡萄膜炎非常显著且潜在颠覆性的进展。”教授说。

Liu Yang

刘洋

, Director of Ophthalmology at Peking University First Hospital, 'We hope that this safe,

北京大学第一医院眼科主任：“我们希望这个安全，

highly efficacious and accessible non-steroidal medicine, VVN461 would be available to benefit patients in near future.'

高效且可及的非甾体类药物，VVN461将于不久的将来惠及患者。

Uveitis is the inflammation of uvea which consists of the iris, ciliary body, and choroid. Uveitis affects approximately 3 million patients in

葡萄膜炎是虹膜、睫状体和脉络膜组成的葡萄膜的炎症。葡萄膜炎影响大约300万患者。

China

中国

with ~60% classified as NIAU

其中约60%被归类为NIAU

.

。

Uveitis may

葡萄膜炎可能

recur

重现

and be chronic, and it is a leading cause of vision loss accounting 10–20% of cases of

并且是慢性的，它是导致视力丧失的主要原因，占病例的10%-20%。

acquired legal blindness.

获得性法定盲。

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

治疗NIAU通常涉及使用局部类固醇，这类药物会带来一些副作用，如眼压升高、伤口愈合延迟和眼部感染。局部类固醇的反复或长期使用可能导致严重的副作用。

effects

效果

, 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..

如眼压升高和白内障。因此，非常需要有效控制葡萄膜炎炎症的同时尽量减少副作用。VVN461 提供了一个有前景的替代方案，利用其靶向、非甾体机制，在保持抗炎效力的同时将这些风险降至最低。

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

VivaVision 已计划与中国CDE进行讨论，并打算向FDA请求召开关于三期临床试验的C类会议。

Abo

订阅

ut VivaVision Biotech

维瓦视觉生物技术公司

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:

维真生物成立于2016年，是一家临床阶段的制药公司，致力于推进一流的眼科疾病治疗方案，并拥有多个在研药物候选产品。该公司主要的研发管线资产包括：

VVN461:

VVN461:

a non-steroidal

非甾体的

dual JAK1/TYK2 immunomodulator for post-operative inflammation after cataract surgery and non-infectious anterior uveitis.

用于白内障手术后炎症和非感染性前葡萄膜炎的双重JAK1/TYK2免疫调节剂。

VVN001: an investigational treatment for dry eye syndrome.

VVN001：一种用于治疗干眼症的在研药物。

VVN1901: a therapy

VVN1901：一种疗法

for

为了

targeting neurotrophic keratitis

针对神经营养性角膜炎

VVN481:

VVN481:

a non-steroidal dual JAK1/TYK2 inhibitor for suprachoroidal delivery to treat posterior/pan-uveitis and posterior inflammatory diseases

一种用于脉络膜上腔递送的非甾体类双重JAK1/TYK2抑制剂，用于治疗后部/全葡萄膜炎及后部炎症性疾病。

VVN432: a non-steroidal JAK inhibitor nasal spray for chronic rhinosinusitis (CRS)

VVN432：一种用于慢性鼻窦炎（CRS）的非甾体JAK抑制剂鼻喷雾剂

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

除了其研发管线外，VivaVision还积极投身于发现和开发针对眼前段和眼后段疾病的更多疗法，以满足未被满足的患者需求。欲了解更多信息，请访问