A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

开始日期2011-05-01

申办/合作机构

Fovea Pharmaceuticals SA

100 项与 Safotibant 相关的临床结果

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100 项与 Safotibant 相关的转化医学

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100 项与 Safotibant 相关的专利（医药）

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项与 Safotibant 相关的文献（医药）

2010-07-01·IDrugs : the investigational drugs journal

Association for Research in Vision and Ophthalmology (ARVO)--2010 Annual Meeting. For Sight: The Future of Eye and Vision Research--part 1.

作者: Hookes, Livia

The 2010 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO), held in Fort Lauderdale, FL, USA, included topics covering new therapeutic developments in the field of eye and vision research. This conference report highlights selected presentations on the development of FOV-2304 (Fovea Pharmaceuticals SA) for the potential treatment of diabetic macular edema; PHA-666859 (Pfizer Inc) for diabetic retinopathy; GTx-878 (GTx Inc) and FCFD-4514S (Genentech Inc) for age-related macular degeneration; SYL-040012 (Sylentis Sau) for ocular hypertension associated with open-angle glaucoma; PEG-PLA-TNP-470 (Harvard Medical School) for ocular neovascularization; recombinant galectin-3 (Senju Pharmaceutical Co Ltd) for corneal injury; and CellBead Neuro (CellMed Inc) for neurological trauma and neurodegeneration.

2010-05-01·Current opinion in investigational drugs (London, England : 2000)

Targeting the kallikrein-kinin system as a new therapeutic approach to diabetic retinopathy.

Review

作者: Sahel, José-Alain ; Combal, Jean-Philippe ; Bélichard, Pierre ; Pruneau, Didier

Diabetic retinopathy (DR) is a major microvascular complication of diabetes mellitus that can lead to visual impairment and blindness. There is no approved pharmacological treatment for DR; however, laser therapy, steroids and anti-VEGF agents appear to provide some benefit. Hyperglycemia, advanced glycation end products, growth factors, and elevated levels of circulating and vitreous cytokines and chemokines can all trigger an inflammatory response of the retinal vasculature. Features of DR can include diabetic macular edema, microhemorrhage, loss of capillaries, development of avascular areas and the vitreo-retinal proliferation of neovessels. The kallikrein-kinin system (KKS) has long been recognized as a key player of inflammatory processes in various organs. Intravitreally administered recombinant plasma kallikrein has been demonstrated to produce retinal vascular leakage and hemorrhage, while both kinin B1 and B2 receptor agonists have induced retinal edema. Furthermore, kallikrein inhibitors and peptide-based B1 receptor antagonists could reduce or block retinal vascular permeability in diabetic rats. In a diabetic rat model, FOV-2304 (Fovea Pharmaceuticals SA), a non-peptide selective B1 receptor antagonist, consistently blocked retinal vascular permeability, inhibited leukocyte adhesion and abolished the retinal mRNA expression of several inflammatory mediators. Although additional studies are required to investigate the role of the KKS in early capillary loss and late-stage neovascularization processes, the blockade of the KKS is a promising therapeutic strategy for DR.

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外链

KEGG	Wiki	ATC	Drug Bank
-	Safotibant	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
黄斑水肿	临床2期	波兰	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床2期	西班牙	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床2期	比利时	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床2期	澳大利亚	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床2期	美国	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床2期	捷克	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床2期	法国	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床2期	以色列	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床2期	德国	Fovea Pharmaceuticals SA	2011-05-01
黄斑水肿	临床1期	意大利	Fovea Pharmaceuticals SA	2011-05-01