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首页 » Ophthalmology:GS-101眼药水提供角膜移植排斥反应解决新方案

Ophthalmology:GS-101眼药水提供角膜移植排斥反应解决新方案

来源:生物谷 2009-09-01 21:01

Ophthalmology杂志公布的数据显示, GS-101可能会阻止角膜移植排斥反应。

Gene Signal是瑞士一家关注新生血管类药物研发的公司。日前公布了临床二期的研究成果,结果表明GS-101眼药水能有效、安全的控制异常的角膜新生血管生长。角膜移植是最常见的一种组织移植过程,每年大约有四万六千人通过角膜移植手术重见光明,而血管新生是角膜移植过程中产生排斥反应的主要因素。

来自德国的科学家Claus Cursiefen等报道了最新的研究结果。Gene Signal公司正在引导展开GS-101眼药水的国际化临床三期的研究,对其角膜新生血管的引起的病理展开研究,进而预防角膜移植排斥反应。

Gene Signal公司CEO,Eric Viaud说"对于Gene Signal公司来说,GS-101眼药水临床二期研究结果是一个重要的里程碑。作为处理眼科新生血管的新方法,我们提供科学化的数据来支持我们正在从事的临床开发项目。临床证明GS-101抑制了一个与新生血管相关的蛋白IRS-1的体内表达。近期,我们将在一些科学性质的论坛上发布GS-101其他具代表性的数据。"(生物谷Bioon.com)

生物谷推荐原始出处:

Ophthalmology September 2009

GS-101 Antisense Oligonucleotide Eye Drops Inhibit Corneal Neovascularization: Interim Results of a Randomized Phase II Trial
Claus Cursiefen, MD1, Felix Bock, PhD1, Folkert K. Horn, PhD1, Friedrich E. Kruse, MD1, Berthold Seitz, MD2, Vincent Borderie, MD3, Beatrice Früh, MD4, Michael A. Thie1, MD5, Frank Wilhelm, MD6, Bernard Geudelin, MD7, Isabelle Descohand, PhD8, Klaus-Peter Steuh1, MD9, Angela Hahn, MD9, Daniel Meller, MD9

1 Department of Ophthalmology, University of Erlangen-Nürnberg, Erlangen, Germany
2 Department of Ophthalmology, University of Saarland, Homburg, Germany
3 National Hospital of Ophthalmology, Paris, France
4 Department of Ophthalmology, University of Bern, Bern, Switzerland
5 Department of Ophthalmology, University of Zürich, Zürich, Switzerland
6 Department of Ophthalmology, Helios Eye Hospital, Schwerin, Germany
7 Mediante GmbH, Basel, Switzerland
8 Therapharm SAS, Boulogne, France
9 Department of Ophthalmology, University of Essen, Essen, Germany


Purpose
Pathologic corneal neovascularization not only reduces corneal transparency and visual acuity, but also is one of the most significant preoperative and postoperative risk factors for graft rejection after corneal transplantation. The aim of this study was to test tolerability and efficacy of gene signal (GS)-101 eye drops, an antisense oligonucleotide against insulin receptor substrate-1, versus placebo on inhibition of progressive corneal neovascularization.

Design
Randomized, double-blind, multicenter, phase II clinical study.

Participants and Controls
Interim analysis on 40 patients with progressive corneal neovascularization resulting from various underlying diseases being nonresponsive to conventional therapy.

Interventions
Four groups of 10 patients were treated for 3 months in this dose-finding study comparing 3 doses of GS-101 (eye drops twice daily; 43, 86, and 172 μg/day total) with placebo (10 patients per group).

Main Outcome Measures
The primary end point was the area covered by pathologic corneal blood vessels, which was measured morphometrically on digitized slit-lamp pictures using image analysis techniques.

Results
GS-101 eye drops were well tolerated. All serious and 95% of all other adverse events were categorized by the investigators as unrelated. In 3 patients, there was a potentially related side effect of ocular surface discomfort. At a dose of 86 μg/day (43 μg/drop), GS-101 eye drops produced a significant inhibition and regression of corneal neovascularization (?2.04±1.57% of total corneal area; P = 0.0047), whereas the low dose tended to stabilize it (0.07±2.94%; P = 0.2088) compared with placebo (0.89±2.15%), where corneal neovascularization progressed in all patients. There was no apparent benefit to the higher dose (1.60±7.63%).

Conclusions
The interim results of this phase II study suggest that GS-101 eye drops at an optimal dose of 86 μg/day are an effective and noninvasive approach specifically to inhibit and regress active corneal angiogenesis, a major risk factor for corneal graft transplantation and graft rejection. Safety concerns were not detected.

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