Boehringer Ingelheim has announced the initiation of the THULITE phase II clinical study (NCT06962839), a trial designed to evaluate the efficacy, safety, and tolerability of BI 1815368, an investigational oral therapy for the treatment of diabetic macular edema (DME).

勃林格殷格翰宣布启动THULITE II期临床研究（NCT06962839），该试验旨在评估BI 1815368（一种用于治疗糖尿病性黄斑水肿（DME）的在研口服疗法）的疗效、安全性和耐受性。

Aiming to Transform the Management of DME

旨在转变DME的管理方式

DME is a leading cause of vision loss in people with diabetes, affecting more than 21 million individuals globally. Current treatments are limited to intravitreal injections administered by retina specialists, often requiring frequent clinic visits and typically addressing only one eye at a time.

糖尿病性黄斑水肿（DME）是糖尿病患者视力丧失的主要原因之一，全球有超过2100万人受到影响。目前的治疗方法仅限于由视网膜专科医生进行的眼内注射，通常需要频繁前往诊所，并且一般一次只能治疗一只眼睛。

BI 1815368 is designed to reduce the permeability of newly formed blood vessels, preventing fluid leakage into the macula caused by DME. Unlike current injection-based treatments, this oral approach could allow for at-home administration and the simultaneous treatment of both eyes, offering a potentially significant shift in disease management..

BI 1815368旨在减少新形成的血管通透性，防止因糖尿病性黄斑水肿（DME）引起的液体渗漏到黄斑。与目前基于注射的治疗方法不同，这种口服方法可以在家自行服用，并同时治疗双眼，为疾病管理带来了潜在的重大转变。

Expert Perspectives on a New Approach

专家对新方法的看法

“An oral therapy for DME could represent a major step forward in its management,” said Charles C. Wykoff, MD, PhD, principal investigator of the trial, Director of Research at Retina Consultants of Texas and Chair of Research at Retina Consultants of America. “A safe and effective systemic therapy would offer an important alternative to repeated intravitreal injections; it could enable more consistent initiation of care earlier in the disease process, improve treatment adherence, and optimize quality of life for patients.”.

“一种用于治疗DME的口服药物可能代表了其管理方面的一大进步，”该试验的主要研究者、德克萨斯州视网膜顾问公司的研究主任及美国视网膜顾问公司的研究主席Charles C. Wykoff博士表示。“一种安全有效的全身性疗法将为反复进行的眼内注射提供重要的替代方案；它可以使患者在疾病过程的早期更一致地开始治疗，提高治疗依从性，并优化患者的生活质量。”

Dario Madani, CEO at PRO RETINA, which has members serving on Boehringer’s DME Clinical Program Steering Committee, also emphasized the patient burden:

PRO RETINA公司的首席执行官达里奥·马达尼（Dario Madani）也强调了患者的负担，该公司有成员在勃林格的DME临床项目指导委员会任职。

“DME is one of the most challenging complications of diabetes, and as vision worsens, people may lose their independence and rely more on loved ones. Patients and caregivers may have to balance work, family obligations, and other diabetes complications while managing their eye condition. We need treatment options that could reduce this burden.”.

“DME 是糖尿病最具挑战性的并发症之一，随着视力恶化，人们可能会失去独立性，更加依赖亲人。患者和护理人员在管理眼部疾病的同时，可能需要平衡工作、家庭责任和其他糖尿病并发症。我们需要能够减轻这种负担的治疗选择。”

Part of a Broader Commitment to Eye Health

对眼部健康更广泛承诺的一部分

BI 1815368 is the fourth investigational compound from Boehringer Ingelheim’s Eye Health portfolio to advance into a phase II clinical trial. The company’s broader program targeting diabetic retinal disease also includes BI 764524, currently being studied in the CRIMSON phase II trial (NCT06321302) for diabetic retinopathy..

BI 1815368 是勃林格殷格翰眼科健康产品组合中第四个进入 II 期临床试验的在研化合物。该公司针对糖尿病视网膜病变的更广泛项目还包括 BI 764524，目前正在进行 CRIMSON II 期试验（NCT06321302）用于糖尿病视网膜病变的研究。

Patrick Bussfeld, MD, PhD, Global Head of Medicine, Eye Health at Boehringer Ingelheim, highlighted the company’s long-term vision:

勃林格殷格翰眼科健康全球医学总监Patrick Bussfeld博士强调了公司的长期愿景：

“At Boehringer Ingelheim, we are working towards a future where earlier intervention leads to long-term outcomes that prevent vision loss. One way we aim to achieve this is by developing oral treatments, which offer patients the ability to be more in control of their condition. By targeting the disease pathway systemically, we also have the potential to prevent DME in one eye while the other is being treated.”.

“在勃林格殷格翰，我们正在朝着一个未来努力，即早期干预能够带来长期的效果，从而预防视力丧失。我们实现这一目标的方式之一是开发口服药物，这能让患者更好地掌控自己的病情。通过系统性地针对疾病通路，我们在治疗一只眼睛的同时，也有潜力预防另一只眼睛发生DME。”