Oculis Completes Enrollment in Phase 3 DIAMOND Trials for OCS-01 in Diabetic Macular Edema

Oculis 完成 OCS-01 治疗糖尿病性黄斑水肿的 3 期 DIAMOND 试验的患者招募工作

April 11, 2025

2025年4月11日

Oculis Holding has announced the completion of patient enrollment in both DIAMOND-1 and DIAMOND-2, the two pivotal Phase 3 trials evaluating OCS-01 eye drops for the treatment of diabetic macular edema (DME). These trials are designed to support global regulatory submissions, including a New Drug Application (NDA) to the U.S.

Oculis Holding宣布已完成DIAMOND-1和DIAMOND-2两项关键的III期试验的患者招募，这些试验评估了OCS-01滴眼液治疗糖尿病性黄斑水肿（DME）的效果。这些试验旨在支持全球监管提交，包括向美国提交新药申请（NDA）。

Food and Drug Administration (FDA)..

食品药品监督管理局 (FDA)。

Over 800 Patients Enrolled Across International Sites

超过800名患者注册于国际各站点

The Phase 3 program enrolled more than 800 patients across 119 investigative sites in the United States and other countries. These trials aim to establish the safety and efficacy of OCS-01, a topical, noninvasive eye drop therapy, for patients with DME—a condition currently lacking approved topical treatments..

第三阶段项目在美国和其他国家的119个研究地点招募了800多名患者。这些试验旨在验证OCS-01的安全性和有效性，这是一种局部、非侵入性的眼药水疗法，用于治疗糖尿病性黄斑水肿（DME）——一种目前尚无获批局部治疗方法的疾病。

NDA Submission Planned Following 2026 Data Readout

计划在2026年数据读出后提交NDA。

Topline results from both DIAMOND trials are expected in the second quarter of 2026. If outcomes are positive, Oculis plans to submit an NDA shortly thereafter.

预计两项 DIAMOND 试验的初步结果将在 2026 年第二季度出炉。如果结果积极，Oculis 计划随后不久提交新药申请 (NDA)。

OCS-01 has the potential to become the first topical eye drop treatment for DME, offering a novel approach for early intervention or for patients who have an insufficient response to anti-VEGF therapy.

OCS-01有潜力成为首个治疗糖尿病性黄斑水肿（DME）的局部滴眼液，为早期干预或对抗VEGF治疗反应不足的患者提供了一种新颖的治疗方法。

Company Statement on Trial Milestone

公司关于审判里程碑的声明

Riad Sherif, MD, Chief Executive Officer of Oculis, commented on the achievement:

Oculis首席执行官Riad Sherif博士对这一成就发表了评论：

“The completion of enrollment in both the DIAMOND-1 and DIAMOND-2 phase 3 trials shows strong focus on disciplined execution. I would like to thank all stakeholders participating in the trials and the whole medical community for their excellent support to advance this program towards NDA submission, which keeps us on track for a topline data readout from both studies in the second quarter of 2026.

“DIAMOND-1 和 DIAMOND-2 三期试验的入组完成展现了我们在执行上的高度专注。我要感谢所有参与试验的利益相关者以及整个医学界，为推动这一项目向新药申请（NDA）提交提供了卓越支持，这也使我们按计划在2026年第二季度获得两项研究的主要数据结果。”

For the months to come, we will remain focused on execution to ensure the program's continued advancement, bringing us closer to potentially providing a transformational solution, with the first noninvasive topical eye drop therapy, for patients suffering from DME.”.

在接下来的几个月里，我们将继续专注于执行，以确保该计划的持续推进，让我们更接近于为患有DME的患者提供一种变革性的解决方案——首个非侵入性局部眼药水疗法。

Upcoming Update at R&D Day

研发日即将到来的更新

Oculis will provide a progress update on the Phase 3 DIAMOND-1 and DIAMOND-2 trials during its upcoming R&D Day, which will take place both in-person and virtually on Tuesday, April 15.

Oculis 将在即将到来的研发日上提供关于三期 DIAMOND-1 和 DIAMOND-2 试验的进展更新，该活动将于 4 月 15 日星期二以线下和线上形式举行。