Initial safety, efficacy and durability data expected in 2H’24

预计2H'24的初始安全性，有效性和耐久性数据

OXFORD, United Kingdom & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Oxular Limited, a clinical-stage ophthalmic company developing long-lasting treatments for retinal disorders, today announces that it has begun dosing in its OXEYE Phase 2 clinical trial evaluating the company’s lead product candidate, suprachoroidal OXU-001, for the treatment of diabetic macular edema (DME).

牛津，英国和剑桥，马萨诸塞州-（商业线）-Oxular Limited，一家开发长期治疗视网膜疾病的临床阶段眼科公司，今天宣布它已开始在其OXEYE 2期临床试验中评估该公司的主要产品候选药物，脉络膜上OXU-001，用于治疗糖尿病性黄斑水肿（DME）。

OXEYE is designed to evaluate the safety, efficacy, and durability of OXU-001 as an innovative treatment option, combining potent broad-acting anti-edema and anti-inflammatory effects with up to one-year durability for high-prevalence retinal disorders, beginning with DME..

OXEYE旨在评估OXU-001作为一种创新治疗方案的安全性，有效性和耐久性，将有效的广谱抗水肿和抗炎作用与高发病率视网膜疾病的长达一年的耐久性相结合，从DME。。

“We are thrilled to have started dosing patients with suprachoroidal OXU-001 in our OXEYE clinical trial, which will evaluate the potential for once-a-year treatment by leveraging our Oxusphere™ sustained-release technology. OXEYE builds on the positive clinical experience to date with our Oxulumis® illuminated microcatheter for in-clinic posterior suprachoroidal delivery,” said Dr.

“我们很高兴在OXEYE临床试验中开始给予脉络膜上OXU-001患者，该试验将通过利用我们的Oxusphere评估每年一次治疗的潜力™ 缓释技术。OXEYE建立在迄今为止我们的Oxulumis®照明微导管的积极临床经验的基础上，用于临床后脉络膜上分娩，“博士说。

Friedrich Asmus, MD, Chief Medical Officer of Oxular. “This marks Oxular’s most significant milestone to date and brings us closer to our goal of developing safe and highly effective treatments to reduce the treatment burden for patients and retinal specialists. We look forward to clinical data from the OXEYE trial next year.”.

Oxular首席医疗官Friedrich Asmus博士。“这标志着Oxular迄今为止最重要的里程碑，使我们更接近开发安全有效的治疗方法以减轻患者和视网膜专家治疗负担的目标。我们期待明年OXEYE试验的临床数据。”。

OXU-001 is dexamethasone formulated in a novel biodegradable drug preparation known as Oxuspheres™. OXU-001 is optimized for delivery to the posterior suprachoroidal space of the eye via Oxulumis®, Oxular’s proprietary illuminated microcatheter. This in-office treatment enables routine access closer to the ocular tissues with high disease activity, which could lead to enhanced efficacy, favorable tolerability, and extended durability of up to one-year..

OXU-001是地塞米松，配制成一种新型可生物降解药物制剂，称为Oxuspheres™. OXU-001经过优化，可通过Oxular专有的照明微导管Oxulumis®输送到眼睛的后脉络膜上腔。这种办公室内治疗可以使常规进入更靠近具有高疾病活动性的眼组织，这可以提高疗效，有利的耐受性，并延长长达一年的耐久性。。

The OXEYE trial is a two-part, randomized Phase 2 trial in patients with DME that is designed to evaluate a single administration of suprachoroidal OXU-001 over 52 weeks. Part A of the trial is expected to randomize 18 patients in the U.S. who have been previously treated with anti-VEGF therapy to one of two dose levels of OXU-001.

OXEYE试验是DME患者的两部分随机2期临床试验，旨在评估52周内单次给予脉络膜上OXU-001。预计该试验的A部分将美国18名先前接受过抗VEGF治疗的患者随机分配至两种剂量水平的OXU-001之一。

Gated by interim read-outs from Part A, Part B will be a masked evaluation of 110 DME patients who have either been previously treated with anti-VEGF therapy or are treatment-naïve, randomized to one of the two dose levels of OXU-001 or Ozurdex® (dexamethasone intravitreal implant). Primary endpoints at Week 24 are safety and efficacy, and patients will continue to be monitored monthly for 52 weeks..

通过A部分的临时读数进行门控，B部分将对110名DME患者进行掩盖评估，这些患者之前曾接受过抗VEGF治疗或未接受过治疗，随机分为两种剂量水平的OXU-001或Ozurdex®（地塞米松玻璃体内植入物）。第24周的主要终点是安全性和有效性，患者将继续每月监测52周。。

“Today’s standard-of-care treatments for DME require frequent injections, which create adherence challenges resulting in suboptimal vision outcomes for many patients,” stated Dr. Anat Loewenstein, MD, Director of the Department of Ophthalmology at the Tel Aviv Medical Center. “It is very exciting that we will soon see patient data of suprachoroidal OXU-001, a potential treatment option with the goal of one treatment a year.”.

特拉维夫医学中心眼科主任Anat Loewenstein博士说：“今天DME的标准治疗方法需要频繁注射，这会造成依从性挑战，导致许多患者的视力结果欠佳。”。“令人兴奋的是，我们很快就会看到脉络膜上OXU-001的患者数据，这是一种潜在的治疗选择，目标是每年进行一次治疗。”。

Oxular expects to report 24-week data from Part A, including safety and durability, in the second half of 2024.

Oxular预计将在2024年下半年报告A部分的24周数据，包括安全性和耐用性。

About Oxular

关于Oxular

Oxular is a biotechnology company developing safe, long-lasting suprachoroidal retinal treatments to improve patients’ vision so they can live better lives. The company has engineered its sustained-release drug formulations to last up to one year following single dosing and delivery technology to access tissues in the posterior suprachoroidal space via a routine, in-office administration.

Oxular是一家生物技术公司，致力于开发安全，持久的脉络膜上视网膜治疗方法，以改善患者的视力，从而过上更好的生活。该公司已经设计了其缓释药物制剂，在单次给药和递送技术之后持续长达一年，以通过常规的办公室内管理进入后脉络膜上腔的组织。

This unique combination aims to improve patients’ vision by increasing therapeutic effectiveness, while reducing side-effects and minimizing the frequency of treatments..

这种独特的组合旨在通过提高治疗效果，减少副作用并最大程度地减少治疗频率来改善患者的视力。。

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Contacts

联络

Cara Mayfield

尊敬的Mayfield

THRUST Strategic Communications

推力战略传播

cara@thrustsc.com

cara@thrustsc.com

Source: Oxular Limited

来源：Oxular Limited

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