Signal12, Inc. (Signal12), a clinical-stage ophthalmic pharmaceutical company focused on first-of-a-kind patented technologies that enable existing drugs to act through unique neural pathways, today announced the alignment of its Phase 3 clinical trial strategy for Pro-ocular™ with the U.S. Food and Drug Administration (FDA).

临床阶段眼科制药公司Signal12专注于首创的专利技术，这些技术使现有药物能够通过独特的神经通路发挥作用。该公司今天宣布，其Pro-ocular™的III期临床试验策略已与美国食品和药物管理局（FDA）达成一致。

Pro-ocular™ is a novel drop-free therapy poised to revolutionize the treatment of ocular Graft-versus-Host Disease (oGvHD). This key regulatory milestone, achieved following a highly productive Type C meeting, sets the stage for Signal12's transformative Phase 3  clinical research in an area of high unmet medical need..

Pro-ocular™ 是一种新型的无滴眼疗法，有望彻底改变眼部移植物抗宿主病 (oGvHD) 的治疗。这一关键的监管里程碑是在一次高效的 C 类会议后达成的，为 Signal12 在高度未满足医疗需求领域的变革性 III 期临床研究奠定了基础。

Ocular Graft-versus-Host Disease, an orphan condition impacting roughly 50,000 patients annually in

眼部移植物抗宿主病，一种每年影响约50,000名患者的罕见疾病，

the United States

美国

, currently has no FDA-approved treatment. Pro-ocular has demonstrated its potential to not only boost tear production but also deliver significant relief from ocular pain, offering a promising new lifeline for patients debilitated by this severe condition.

，目前尚无FDA批准的治疗方法。Pro-ocular不仅展示了增加泪液分泌的潜力，还能显著缓解眼部疼痛，为受这种严重疾病困扰的患者提供了充满希望的新救星。

'This alignment on the Phase 3 requirements with the FDA represents a major step forward for patients suffering from oGvHD,' said

“与FDA就第三阶段要求达成一致，这对遭受oGvHD的患者来说是一个重大的进步，”

Tom Mitro

汤姆·米特罗

, Chief Executive Officer at Signal12. 'We believe Pro-ocular can significantly improve patient's quality of life by providing sustainable relief from the signs and symptoms of this highly debilitating disease. Our team looks forward to initiating our Phase 3 trial as soon as possible.'

Signal12的首席执行官表示：“我们相信Pro-ocular可以通过提供对这种高度致残性疾病的症状和体征的持续缓解，显著改善患者的生活质量。我们的团队期待尽快启动第三阶段试验。”

In a robust Phase 2 trial conducted over 10 weeks—a double-masked, placebo-controlled study involving 33 patients randomized 2:1 to Pro-ocular 1% or placebo—results revealed statistically significant and clinically meaningful improvements across multiple efficacy endpoints. These improvements, which included improved  corneal staining and ocular symptom scores , were sustained over a two-year open-label extension without any drug-related serious adverse events.

在一项为期 10 周的强力 II 期试验中（双盲、安慰剂对照研究，涉及 33 名患者，按 2:1 随机分配至 Pro-ocular 1% 或安慰剂），结果显示在多个疗效终点上取得了统计学显著且临床意义重大的改善。这些改善包括角膜染色和眼部症状评分的提升，在为期两年的开放标签延长期中得以持续，且未发生任何与药物相关的严重不良事件。

The trial, executed in collaboration with .

审判，与合作执行。

Harvard Medical School's

哈佛医学院的

renowned Mass Eye and Ear Infirmary, reinforces Pro-ocular's potential as a breakthroughr therapy in oGvHD management. Detailed study outcomes are accessible at

著名的麻省眼耳医院加强了Pro-ocular作为oGvHD管理中的突破性疗法的潜力。详细的研究结果可以在以下位置获取：

'The FDA's positive feedback on our Phase 3 trial design underscores the urgent need for new and effective interventions for oGvHD,' stated

“FDA对我们第三阶段试验设计的积极反馈强调了对oGvHD新的有效干预措施的迫切需求，”

Marv Garrett

马夫·加勒特

, Senior Vice President of Regulatory Affairs at Signal12. 'Our Phase 2 results, showing meaningful improvements in corneal staining and ocular dryness, highlight the disruptive potential of Pro-ocular as a potential treatment for this disease. We're highly enthusiastic about advancing to the next stage of clinical research.'.

Signal12监管事务高级副总裁。“我们的二期试验结果表明，角膜染色和眼部干燥症状有显著改善，这突显了Pro-ocular作为该疾病潜在治疗手段的颠覆性潜力。我们对推进到临床研究的下一阶段充满热情。”

Having achieved this important regulatory milestone, Signal12 is now strategically positioned to drive forward a Phase 3 clinical program that could redefine the treatment landscape for oGvHD. This development underscores the company's commitment to addressing critical therapeutic gaps.

在达成了这一重要的监管里程碑后，Signal12 现在已战略性地准备推动一项可能重新定义 oGvHD 治疗领域的 III 期临床计划。这一进展凸显了该公司致力于解决关键治疗空白的承诺。

About Signal12 Inc.

关于Signal12公司

Signal12, Inc. is a Phase 3-ready ophthalmic pharmaceutical company. Our proprietary topical drug, Pro-ocular™, has been shown to be safe and effective in Phase 2 clinical studies, demonstrating significant reductions in the signs and symptoms of ocular Graft-versus-Host Disease (oGvHD)—a chronic, debilitating condition following an allogeneic stem cell transplant.

Signal12, Inc.是一家处于第三阶段的眼科制药公司。我们的专利局部药物Pro-ocular™在第二阶段临床研究中已被证明是安全有效的，显示出在眼部移植物抗宿主病（oGvHD）的症状和体征上有显著减轻——这是一种在异基因干细胞移植后出现的慢性、致残性疾病。

Pro-ocular™ is the only effective treatment for oGvHD, employing transappendageal delivery to precisely target the ophthalmic branch of the trigeminal nerve..

Pro-ocular™ 是治疗 oGvHD 的唯一有效方法，通过经附属器输送精准靶向三叉神经的眼支。