Papangkorn Kongnara, Prendergast Eri, Higuchi John W, Brar Balbir, Higuchi William I
Aciont, Inc. , Salt Lake City, Utah.
J Ocul Pharmacol Ther. 2017 Dec;33(10):753-762. doi: 10.1089/jop.2017.0053. Epub 2017 Oct 12.
To investigate the efficacy and safety of dexamethasone sodium phosphate administered through Visulex system (DSP-Visulex) in treating experimental uveitis.
Uveitis was induced in rabbits by subcutaneous injections of complete Freund's adjuvant and an intravitreal injection of H37RA antigen. After induction, the animals of the control group received no treatment and the others received various treatment regimens of DSP-Visulex. Each regimen was different in DSP strength (4%, 8%, and 15%), application time, or treatment frequency. Efficacy and safety of DSP-Visulex were evaluated by ophthalmic observations and histopathological examinations for ocular inflammations and pathology.
The control group exhibited panuveitis with significant inflammation in the vitreous, choroid, and retina, but less in the conjunctiva, cornea, and anterior chamber. The uveitis occurred within 24 h after induction and persisted throughout the study in the control group. All treatments showed some reduction in inflammation in the vitreous, choroid, and retina. The higher dose regimens generally showed more rapid and higher degree of resolution than the lower dose regimens. The posterior eye tissues of the 15% and 8% DSP-Visulex appeared normal with minimal or no inflammation, whereas the untreated eye and the 4% DSP-Visulex eyes showed minimal response.
All DSP-Visulex regimens suppressed the signs of inflammation and were well tolerated over the course of a 29-day study. The 8% and 15% DSP-Visulex treatment regimens were safe and efficacious for anterior, intermediate, and posterior uveitis. On the other hand, the 4% DSP-Visulex regimen may only be considered for anterior and intermediate uveitis.
研究通过Visulex系统给药的地塞米松磷酸钠(DSP-Visulex)治疗实验性葡萄膜炎的疗效和安全性。
通过皮下注射完全弗氏佐剂和玻璃体内注射H37RA抗原诱导兔葡萄膜炎。诱导后,对照组动物不接受治疗,其他动物接受DSP-Visulex的各种治疗方案。每种方案在DSP浓度(4%、8%和15%)、应用时间或治疗频率上有所不同。通过眼科观察和眼部炎症及病理的组织病理学检查评估DSP-Visulex的疗效和安全性。
对照组表现为全葡萄膜炎,玻璃体、脉络膜和视网膜有明显炎症,但结膜、角膜和前房炎症较轻。葡萄膜炎在诱导后24小时内发生,并在对照组整个研究过程中持续存在。所有治疗均使玻璃体、脉络膜和视网膜的炎症有所减轻。高剂量方案通常比低剂量方案显示出更快且更高程度的炎症消退。15%和8% DSP-Visulex治疗后的眼后组织外观正常,炎症轻微或无炎症,而未治疗的眼睛和4% DSP-Visulex治疗的眼睛反应最小。
在为期29天的研究过程中,所有DSP-Visulex方案均能抑制炎症迹象,且耐受性良好。8%和15% DSP-Visulex治疗方案对前、中、后葡萄膜炎均安全有效。另一方面,4% DSP-Visulex方案可能仅适用于前葡萄膜炎和中间葡萄膜炎。