VivaVision Biotech Receives Positive FDA Feedback on VVN461LD Development for Postoperative Inflammation

维瓦视觉生物技术公司收到FDA关于VVN461LD用于术后炎症开发的积极反馈

June 11, 2025

2025年6月11日

VivaVision Biotech has announced encouraging written preliminary comments from the U.S. Food and Drug Administration (FDA) in advance of a planned Type C meeting, originally scheduled for early June 2025. The comments relate to the development of VVN461LD, a potent dual JAK1/TYK2 inhibitor intended for the treatment of postoperative inflammation following cataract surgery..

VivaVision Biotech 宣布，已收到美国食品药品监督管理局 (FDA) 在计划中的 C 类会议前发出的鼓舞人心的书面初步意见。该会议原定于 2025 年 6 月初举行。这些意见涉及 VVN461LD 的开发，VVN461LD 是一种强效的双重 JAK1/TYK2 抑制剂，旨在用于治疗白内障手术后的术后炎症。

FDA Feedback Supports NDA Development Path

FDA反馈支持NDA开发路径

According to VivaVision, the FDA’s Division of Ophthalmology, Office of Specialty Medicine, responded positively to the company’s submitted questions regarding the regulatory strategy for VVN461LD. The agency also agreed that the U.S. Phase 2 trial (NCT06164743) may serve as one of the two pivotal trials required for a future New Drug Application (NDA) submission..

根据维瓦视觉公司的消息，美国食品药品监督管理局（FDA）眼科部门、特殊医学办公室对该公司的VVN461LD监管策略相关提交的问题给予了积极回应。该机构还同意，美国二期临床试验（NCT06164743）可作为未来新药申请（NDA）所需的两个关键试验之一。

Phase 2 Study Demonstrates Promising Efficacy

第二阶段研究显示良好的疗效前景

The U.S. Phase 2 trial was a multicenter, randomized, double-masked, vehicle-controlled study that included 91 participants undergoing unilateral cataract surgery via phacoemulsification and lens replacement (CELR).

美国第二阶段试验是一项多中心、随机、双盲、安慰剂对照的研究，包括91名通过超声乳化和晶状体置换（CELR）进行单侧白内障手术的参与者。

At Day 14 post-surgery, 60.0% (18/30) of patients in the VVN461LD 1.0% group and 53.3% (16/30) in the 0.5% group achieved anterior chamber cell (ACC) Grade 0, compared to only 19.4% (6/31) in the vehicle group, demonstrating a statistically significant reduction in inflammation (p=0.0012 and p=0.0057, respectively)..

在术后第14天，VVN461LD 1.0%组中60.0%（18/30）的患者和0.5%组中53.3%（16/30）的患者达到了前房细胞（ACC）等级0，而安慰剂组仅为19.4%（6/31），显示出炎症的显著减少（分别为p=0.0012和p=0.0057）。

CEO Statement: Potential Alternative to Corticosteroids

CEO声明：皮质类固醇的潜在替代品

Wang Shen, PhD, CEO of VivaVision, emphasized the significance of this development:

王珅博士，维伟思医疗CEO，强调了这项发展的重要性：

“VVN461 is positioned to be a safer but equally effective alternative to ocular corticosteroids, a highly meaningful advancement in ocular anti-inflammatory therapies for patients. These positive comments from the FDA recognized VVN461's potential as an excellent ocular anti-inflammatory drug, and it also significantly shortens the time before patients in need can use the drug.”.

“VVN461 有望成为眼部皮质类固醇更安全但同样有效的替代品，这是对患者眼部抗炎治疗的一项非常有意义的进步。FDA 的这些正面评价认可了 VVN461 作为一种优秀的眼部抗炎药物的潜力，也大大缩短了急需用药的患者能够使用该药物的时间。”

Development Outlook and Next Steps

开发前景与下一步措施

VivaVision stated that the preliminary FDA feedback provides a clear path forward for VVN461LD’s development in the U.S. As a result, the previously scheduled Type C meeting has been canceled.

维瓦视觉表示，FDA的初步反馈为VVN461LD在美国的开发提供了明确的路径。因此，此前计划的C类会议已经取消。

Looking ahead, the company plans to initiate Phase 3 clinical trials in both the U.S. and China, while also engaging with the Chinese Center for Drug Evaluation (CDE) to advance regulatory discussions and align development strategies across both markets.

展望未来，该公司计划在美国和中国启动第三阶段临床试验，同时与中国药品审评中心（CDE）合作，推动监管讨论，并在两个市场中协调开发策略。