PURPOSE Most patients with retinal vascular disease require chronic, regular treatments to maximize visual potential. This places a challenging burden on the patient and is one reason why real-world visual outcomes often lag the results seen in clinical trials. REVIEW Sustained drug delivery devices have long been considered one way to alleviate this difficulty. In particular, devices with refillable reservoirs aim to take advantage of existing drugs to improve their pharmacokinetics and reduce treatment frequency. Very few devices utilizing a refillable reservoir have reached human clinical trials, however. Only one, the Port Delivery System (PDS) with ranibizumab, has received FDA approval. Despite this milestone, the PDS was voluntarily withdrawn one year after its introduction due to product quality challenges related to the septum of the device. The PDS was recently returned to the market following modifications to the implant as well as the refill-exchange needle. CONCLUSION Although devices with refillable reservoirs have increased challenges related to their inherent complexity, the potential for improved patient outcomes merit further development of this technology.

中文翻译：

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用于视网膜血管疾病的可再填充药物储液器。


目的 大多数视网膜血管疾病患者需要慢性、定期治疗，以最大限度地发挥视觉潜力。这给患者带来了具有挑战性的负担，这也是现实世界的视觉结果经常滞后于临床试验结果的原因之一。综述 长期以来，持续给药装置一直被认为是缓解这一困难的一种方法。特别是，带有可再填充储液器的设备旨在利用现有药物来改善其药代动力学并降低治疗频率。然而，很少有使用可再填充储液槽的设备进入人体临床试验。只有一种，即含雷珠单抗的端口输送系统 （PDS） 已获得 FDA 批准。尽管有这一里程碑，但由于与器械隔膜相关的产品质量挑战，PDS 在推出一年后自愿撤回。PDS 在对植入物和再填充交换针进行修改后最近重新投放市场。结论 尽管带有可再填充储液器的设备因其固有的复杂性而面临更大的挑战，但改善患者预后的潜力值得进一步开发这项技术。