European Commission Approves Ryjunea for Slowing Progression of Pediatric Myopia

欧盟委员会批准Ryjunea用于减缓儿童近视的进展

June 10, 2025

2025年6月10日

The European Commission (EC) has granted marketing authorization for Ryjunea (SYD-101), Sydnexis’ proprietary low-dose atropine formulation. This marks a historic milestone as Ryjunea becomes the first and only approved pharmaceutical treatment in the European Union for slowing the progression of pediatric myopia..

欧盟委员会（EC）已授予Ryjunea（SYD-101），Sydnexis专有的低剂量阿托品制剂的上市许可。这标志着一个历史性的里程碑，因为Ryjunea成为欧盟第一个也是唯一被批准用于减缓儿童近视进展的药物治疗。

Indication and Product Details

适应症与产品详情

Ryjunea is a 0.1 mg/ml ophthalmic solution intended for once-daily use. It is indicated for children aged 3 to 14 years at the initiation of treatment, who exhibit myopia progression of 0.5 diopters (D) or more per year, with a refractive error ranging from -0.5 D to -6.0 D.

Ryjunea 是一种 0.1 毫克/毫升的眼用溶液，每日使用一次。适用于治疗开始时年龄在 3 至 14 岁之间、每年近视进展达到或超过 0.5 屈光度 (D)、屈光误差在 -0.5 D 至 -6.0 D 范围内的儿童。

Backed by Clinical Evidence from the STAR Study

得到STAR研究的临床证据支持

The approval is based on data from the pivotal Phase 3 STAR study, which evaluated the efficacy and safety of SYD-101 in children with progressive myopia. The trial demonstrated that Ryjunea slowed the annual progression of myopia by 30% over two years compared to placebo. It also assessed the drug’s potential in reducing the risk of co-morbidities linked to high myopia..

该批准基于关键的三期STAR研究的数据，该研究评估了SYD-101在进展性近视儿童中的有效性和安全性。试验表明，与安慰剂相比，Ryjunea在两年内将近视的年度进展减缓了30%。研究还评估了该药物在降低与高度近视相关的并发症风险方面的潜力。

Industry Perspectives

行业视角

“This marks a significant milestone for Sydnexis and, most importantly, for pediatric patients with progressive myopia, their families, and physicians as the first and only approved pharmaceutical treatment option in Europe,” said Perry Sternberg, CEO of Sydnexis. “This approval is an endorsement of the potential benefit SYD-101 can provide to millions of patients globally and reinforces the critical importance of early intervention.”.

“这对Sydnexis来说是一个重要的里程碑，更重要的是，对患有进行性近视的儿科患者、他们的家人和医生而言，这是欧洲首个且唯一获批的药物治疗选择，”Sydnexis首席执行官佩里·斯特恩伯格表示。“此次批准证明了SYD-101可能为全球数百万患者带来的益处，并再次强调了早期干预的关键重要性。”

Commercialization Strategy and Global Outlook

商业化战略与全球展望

The EC’s decision follows a recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). As part of a strategic partnership, Santen has licensed commercialization rights for SYD-101 in Europe, the Middle East, and Africa (EMEA) and will launch the product in these regions under the brand name Ryjunea..

欧盟委员会的决定遵循了人用药品委员会（CHMP）近期的积极意见。作为战略合作伙伴关系的一部分，Santen已获得SYD-101在欧洲、中东和非洲（EMEA）的商业化权利，并将在这几个地区以品牌名Ryjunea推出该产品。

“The EU approval of SYD-101 is a recognition of the compelling safety and efficacy data generated from our landmark STAR study,” said Patrick Johnson, PhD, President of Sydnexis. “This validates the potential benefit that SYD-101 can provide to pediatric myopes in Europe, and we are excited about our continued interactions with the FDA leading up to our October 23 PDUFA date.”.

“欧盟对SYD-101的批准是对我们具有里程碑意义的STAR研究生成的安全性和有效性数据的认可，”Sydnexis总裁Patrick Johnson博士说。“这验证了SYD-101可能为欧洲的儿童近视患者带来的益处，我们期待在10月23日PDUFA日期之前与FDA保持持续的互动。”