Outlook Therapeutics Seeks FDA Meeting After Second CRL for ONS-5010

Outlook Therapeutics 在收到第二份关于ONS-5010的完整回应函后寻求与FDA会面

September 04, 2025

2025年9月4日

Outlook Therapeutics has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) after receiving a second complete response letter (CRL) regarding its biologics license application (BLA) for ONS-5010 (bevacizumab-vikg). The investigational therapy is being developed for the treatment of wet age-related macular degeneration (AMD)..

Outlook Therapeutics 在收到关于其生物制品许可申请（BLA）ONS-5010（贝伐单抗-vikg）的第二封完整回应函（CRL）后，已向美国食品药品监督管理局（FDA）提交了A类会议请求。该在研疗法正被开发用于治疗湿性年龄相关性黄斑变性（AMD）。

ONS-5010 is a recombinant humanized monoclonal antibody that selectively binds to all isoforms of vascular endothelial growth factor (VEGF) with high affinity. It neutralizes VEGF activity by sterically blocking its interaction with VEGFR-1 (Flt-1) and VEGFR-2 (KDR) on endothelial cells.

ONS-5010是一种重组人源化单克隆抗体，能够以高亲和力选择性结合血管内皮生长因子（VEGF）的所有异构体。它通过空间位阻阻断VEGF与内皮细胞上的VEGFR-1（Flt-1）和VEGFR-2（KDR）的相互作用，从而中和VEGF的活性。

Clarifying FDA Requirements

明确FDA要求

The Type A meeting is intended to clarify the confirmatory efficacy evidence requested by the FDA in the CRL issued on August 27, 2025. The agency noted that ONS-5010 did not meet the primary efficacy endpoint in the NORSE EIGHT trial and therefore recommends the submission of additional confirmatory data to support the application.

A类会议旨在澄清FDA在2025年8月27日发布的完整回复函（CRL）中要求的确证性疗效证据。该机构指出，ONS-5010在NORSE EIGHT试验中未达到主要疗效终点，因此建议提交额外的确证性数据以支持申请。

However, the FDA acknowledged that the NORSE TWO pivotal trial did meet its safety and efficacy endpoints..

然而，FDA 承认 NORSE TWO 关键试验确实达到了其安全性和有效性终点。

Outlook Therapeutics resubmitted the BLA in February 2025, and it was accepted by the FDA in April 2025. The resubmission was based on NORSE EIGHT clinical trial results and additional chemistry, manufacturing, and controls (CMC) data as requested by the agency.

Outlook Therapeutics于2025年2月重新提交了BLA，并于2025年4月被FDA接受。重新提交的内容基于NORSE EIGHT临床试验结果以及机构要求的额外化学、制造和控制（CMC）数据。

Company Perspective

公司视角

Commenting on the request, Bob Jahr, CEO of Outlook Therapeutics, stated:

针对这一请求，Outlook Therapeutics首席执行官鲍勃·雅赫表示：

“We believe this Type A meeting will provide us with additional clarity on the FDA’s requirements to remedy the deficiency identified in the CRL. The Outlook Therapeutics team remains dedicated to our mission to provide patients in the US with a safe and effective alternative to compounded bevacizumab, which has been used off-label as a first-line treatment for wet-AMD for years despite concerns around potency, sterility, consistency, and regulatory oversight associated with the use of compounded products.”.

“我们相信，这次A类会议将为我们提供有关FDA要求的更多明确信息，以弥补CRL中指出的缺陷。Outlook Therapeutics团队仍然致力于我们的使命，即为美国患者提供一种安全有效的复合贝伐单抗替代品。多年来，尽管对复合产品在效价、无菌性、一致性以及监管监督方面存在担忧，复合贝伐单抗仍被用作湿性AMD的一线治疗药物。”

Progress in Europe

欧洲的进展

Despite regulatory hurdles in the U.S., Outlook Therapeutics has seen positive momentum in Europe. In March 2024, the European Medicines Agency (EMA) issued a positive CHMP opinion on ONS-5010. Subsequently, in June 2025, the product, marketed under the name LYTENAVA (bevacizumab gamma), became commercially available in Germany and the UK for the treatment of wet AMD..

尽管在美国面临监管障碍，Outlook Therapeutics在欧洲取得了积极的进展。2024年3月，欧洲药品管理局（EMA）对ONS-5010发表了积极的CHMP意见。随后，在2025年6月，该产品以LYTENAVA（贝伐单抗γ）为商品名，在德国和英国上市，用于治疗湿性AMD。