iStar Medical has announced positive 5-year results from the STAR-GLOBAL trial evaluating the long-term safety and efficacy of the MINIject device in patients with open-angle glaucoma. STAR-GLOBAL is an extension trial designed to investigate outcomes up to five years following implantation. MINIject is currently the only commercially available supraciliary minimally invasive glaucoma surgery (MIGS) implant, developed to enhance natural fluid outflow and effectively reduce intraocular pressure (IOP)..

iStar Medical公司宣布了STAR-GLOBAL试验的积极5年结果，该试验评估了MINIject装置在开角型青光眼患者中的长期安全性和有效性。STAR-GLOBAL是一项扩展试验，旨在研究植入后长达五年的结果。MINIject是目前唯一商业可用的睫状上腔微创青光眼手术（MIGS）植入物，旨在增强自然液体流出并有效降低眼内压（IOP）。

Sustained IOP Reduction in Five Years

五年内眼压持续降低

According to iStar Medical’s press release, MINIject demonstrated a sustained and significant 38% reduction in IOP at the 5-year follow-up. The STAR-GLOBAL study included 47 participants, of whom:

根据iStar Medical的新闻稿，MINIject 在5年随访时显示出持续且显著的38%眼压降低。STAR-GLOBAL 研究包括47名参与者，其中：

• 83% achieved a >20% reduction in IOP from baseline.

• 83% 的患者实现了从基线开始眼压降低超过 20%。

• 80% maintained an IOP of 18 mmHg or less at the 5-year follow-up.

• 80%的患者在5年随访时眼压维持在18毫米汞柱或以下。

• 32% of patients no longer require topical medications for IOP control.

• 32%的患者不再需要局部药物来控制眼压。

The company also reported a favorable safety profile with no adverse events observed throughout the study period.

公司还报告了良好的安全性，在整个研究期间未观察到不良事件。

Investigator and Executive Commentary

调查员和执行评论

Dr. Karsten Klabe, Chief Surgeon at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, and a key investigator in the STAR trials, commented:

德国杜塞尔多夫Breyer, Kaymak & Klabe眼科手术中心的首席外科医生，STAR试验的关键研究者卡尔斯滕·克拉贝博士评论道：

'These very positive five-year follow-up results provide further validation of MINIject as a safe, standalone procedure and an effective longer-term treatment option for glaucoma patients. This gives us further assurance that MINIject can continue to benefit patients even half a decade post-surgery.'.

“这些非常积极的五年随访结果进一步验证了MINIject作为一种安全、独立的手术程序，以及作为青光眼患者的长期有效治疗选择。这使我们更加确信，即使在手术后五年，MINIject仍能继续造福患者。”

Michel Vanbrabant, CEO of iStar Medical, also expressed confidence in the device’s long-term impact:

米歇尔·范布拉班特，iStar Medical公司首席执行官，也对该设备的长期影响表示了信心：

'iStar Medical remains committed to further validating this hypothesis in its future studies, positioning MINIject as the preferred surgical implant device among key opinion leaders, doctors, patients, and investors. With over 5000 patients now implanted, we continue to progress the development of MINIject to address a significant unmet need in key global markets.'.

“iStar Medical 仍致力于在其未来的研究中进一步验证这一假设，将 MINIject 定位为关键意见领袖、医生、患者和投资者首选的外科植入装置。随着目前已有超过5000名患者接受植入，我们继续推进 MINIject 的开发，以满足全球关键市场中显著未被满足的需求。”

Strategic Developments and Future Outlook

战略发展与未来展望

iStar Medical also announced that its partnership with AbbVie, initiated in 2022, has ended. The company is now operating independently. iStar Medical remains on track with the continued commercial rollout of MINIject in Europe and plans to submit an application for U.S. FDA approval in 2028.

iStar Medical 还宣布，与艾伯维 (AbbVie) 自 2022 年开始的合作关系已经结束，目前公司正在独立运营。iStar Medical 仍在按计划继续在欧洲推广 MINIject 的商业化，并计划在 2028 年提交美国 FDA 批准申请。