Opthea Publishes Phase 2b Trial Data for Wet AMD

Opthea发布湿性AMD的2b期试验数据

March 04, 2025

2025年3月4日

Opthea has announced new findings from its phase 2b clinical trial evaluating sozinibercept for treating wet age-related macular degeneration (AMD). The results, published in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina, provide critical insights into patient response based on angiographic lesion characteristics..

Opthea 宣布了其评估 sozinibercept 治疗湿性年龄相关性黄斑变性 (AMD) 的 2b 期临床试验的新发现。结果发表在同行评审期刊《眼科手术、激光与影像》(OSLI) 视网膜上，基于血管造影病变特征提供了关于患者反应的关键见解。

Key Findings from the Phase 2b Trial

2b期试验的主要发现

The study highlights that the baseline characteristics of choroidal neovascularization (CNV) lesions and the presence or absence of retinal angiomatous proliferation (RAP) may predict visual and anatomical outcomes in patients undergoing treatment. Notably, in patients with occult and minimally classic lesions excluding RAP (73% of the total study population), sozinibercept combination therapy demonstrated:.

研究强调，脉络膜新生血管（CNV）病变的基线特征以及是否存在视网膜血管瘤样增生（RAP）可能预测接受治疗患者的视力和解剖学结果。值得注意的是，在排除RAP的隐匿性和极小典型病变患者中（占总研究人群的73%），索齐尼贝cept联合治疗显示：

• A statistically significant additional 5.7-letter mean gain in best corrected visual acuity (BCVA) compared to ranibizumab monotherapy.

• 与雷珠单抗单药治疗相比，最佳矫正视力（BCVA）在统计学上有显著增加5.7个字母的平均增益。

• A greater proportion of patients gaining ≥15 letters.

• 更高比例的患者视力提高≥15个字母。

• Improved retinal drying with a reduced CNV area at 24 weeks.

• 24周时CNV面积减少，视网膜干燥效果改善。

Opthea’s Phase 3 Program: COAST and ShORe Trials

Opthea的三期项目：COAST和ShORe试验

Opthea’s comprehensive phase 3 wet AMD program consists of two concurrent, multicenter, double-masked, randomized clinical trials:

奥普西亚全面的三期湿性AMD项目包括两个同时进行的多中心、双盲、随机临床试验：

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COAST (Combination OPT-302 with Aflibercept Study):

海岸（组合OPT-302与阿柏西普研究）：

Investigates sozinibercept in combination with aflibercept.

研究了索齐尼贝塞普与阿弗利贝塞普的联合应用。

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ShORe (Study of OPT-302 in Combination with Ranibizumab):

ShORe（OPT-302与雷珠单抗联合用药研究）：

Evaluates sozinibercept in combination with ranibizumab.

评估索齐尼贝普与雷珠单抗联合使用的效果。

According to Frederic Guerard, PharmD, Chief Executive Officer of Opthea, the predictive value of angiographic lesion characteristics aligns with findings from real-world trials and has been instrumental in shaping the phase 3 clinical program. Both trials feature a high proportion of enrolled patients with lesion types most likely to respond to treatment..

根据Opthea首席执行官弗雷德里克·盖拉德（Frederic Guerard）药学博士的说法，血管造影病变特征的预测价值与真实世界试验的结果一致，并在塑造第三阶段临床试验计划中发挥了重要作用。两项试验中都包含了高比例最有可能对治疗产生反应的病灶类型的患者。

Looking Ahead: Phase 3 Trial Readouts

展望未来：第三阶段试验结果

Opthea anticipates topline data readouts from:

Opthea 预计将从以下方面获得顶线数据读数：

• COAST in early Q2 2025

• 2025年第二季度初COAST

• ShORe in mid-2025

• 2025年中ShORe

These results will be crucial in determining the clinical viability of sozinibercept as a combination therapy for wet AMD, potentially leading to new treatment options for patients worldwide.

这些结果对于确定苏济尼贝普作为湿性年龄相关性黄斑变性联合疗法的临床可行性至关重要，可能为全球患者带来新的治疗选择。

Reference:

参考：

https://journals.healio.com/doi/10.3928/23258160-20250108-04

https://journals.healio.com/doi/10.3928/23258160-20250108-04