Santen Announces Preliminary Results of Overseas Clinical Trials of Two Glaucoma Drug Candidates.OSAKA, Japan -- Santen Pharmaceutical Co., Ltd. (President: Takakazu Morita) announced preliminary results of the overseas clinical trials of two drug candidates for lowering intraocular pressure intraocular pressure n. The pressure of the intraocular fluid within the eye. intraocular pressure (in´tr in glaucoma and ocular hypertension: an angiotensin II receptor antagonist angiotensin II receptor antagonist Pharmacology Any of a family of agents-eg losartan and valsartan, which block the binding of angiotensin II–A-II to its cognate cell membrane receptors–AT1, AT2, and others; 1st , DE- de- word element [L.], down; from; sometimes negative or privative, and often intensive. de- pref. 1. Do or make the opposite of; reverse: decomposition. 2. 092 (INN: Olmesartan), and a prostaglandin derivative, DE-085 (INN: Tafluprost). --DE-092 (INN: Olmesartan) Santen has conducted an early Phase II clinical study of DE-092 in the United States through its wholly-owned subsidiary, Santen Incorporated, based in Napa, California, U.S.A. The U.S. study aimed to explore DE-092's IOP-lowering effect, and the dose-response relationship between several concentrations of DE-092. Although data analysis indicated some IOP IOP intraocular pressure. IOP Intraocular pressure, see there reduction for DE-092, the efficacy was insufficient, and no clear dose-response relationship was seen among the DE-092 concentrations. Therefore, Santen plans to consider development options such as conducting another dose-response study, and re-positioning of DE-092 in the U.S. and Europe after the Japanese Phase II results are available. In Japan, DE-092 demonstrated a certain IOP-lowering effect in an early Phase II study, and Santen is currently conducting a late Phase II study as originally planned. --DE-085 (INN: Tafluprost) Santen is conducting several DE-085 comparison studies in the U.S. and Europe. Through its wholly-owned subsidiary, Santen Oy, based in Tampere, Finland, Santen has conducted a European Phase III trial which was designed to confirm DE-085's non-inferiority to latanoprost ophthalmic solution ophthalmic solution n. A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. 0.005% (latanoprost). The data analysis demonstrated DE-085's strong IOP-lowering effect as expected for prostaglandins, but the drug did not demonstrate non-inferiority to latanoprost for the primary endpoint. However, this study is ongoing, and Santen will conduct a detailed analysis once final study results are available. Santen will review the development plan for DE-085 in the U.S. and Europe after completing a comprehensive statistical analysis of data from another comparison study versus timolol maleate ti·mo·lol maleate n. A beta-blocker drug used primarily in the treatment of hypertension and after myocardial infarction. timolol maleate, (tim´ ophthalmic solution 0.5% (timolol timolol /ti·mo·lol/ (ti´mo-lol) a nonselective beta-adrenergic blocking agent used as the maleate salt in the treatment of hypertension, the treatment and prophylaxis of recurrent myocardial infarction and the prophylaxis of migraine; ) which is currently ongoing in the U.S. and Europe. In Japan, Santen has conducted several Phase III studies including a comparison study with latanoprost which demonstrated DE-085's non-inferiority to latanoprost. The remaining studies are on schedule and progress towards a Japanese NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any filing is continuing as planned. Santen will announce its future overseas development plans for these two product candidates when a decision is made. (For reference) DE-092 (INN: Olmesartan) DE-092 is a drug candidate developed by Sankyo Co., Ltd., Tokyo, a wholly-owned subsidiary of Daiichi Sankyo Co., Ltd., under the development code CS-088. Santen acquired the global development, manufacturing and marketing rights to the ophthalmic form of olmesartan through an agreement with Sankyo in March 2002 and is currently conducting clinical development. DE-085 (INN: Tafluprost) DE-085 is a novel prostaglandin drug candidate being studied for the reduction of intraocular pressure in primary open angle glaucoma and ocular hypertension. DE-085 is under co-development by Santen and Asahi Glass Co., Ltd., Tokyo. Santen is conducting pharmaceutical and clinical development, while Asahi Glass is responsible for manufacturing development of the active pharmaceutical ingredient. Angiotensin II receptor antagonist Angiotensin II angiotensin II n. An octapeptide that is a potent vasopressor and a powerful stimulus for production and release of aldosterone from the adrenal cortex. is a protein which causes an increase in blood pressure by constricting con·strict v. con·strict·ed, con·strict·ing, con·stricts v.tr. 1. To make smaller or narrower by binding or squeezing. 2. To squeeze or compress. 3. blood vessels. Angiotensin II receptor antagonists control blood pressure by acting on the angiotensin II receptor. Prostaglandin Prostaglandin is one of a number of physiologically active substances that participate in a wide range of body functions such as the dilation dilation /di·la·tion/ (di-la´shun) 1. the act of dilating or stretching. 2. dilatation. di·la·tion n. 1. of blood vessels, control of blood pressure, and dilation of respiratory system. Latanoprost ophthalmic solution 0.005% (latanoprost) Latanoprost is a prostaglandin drug for the reduction of intraocular pressure in open angle glaucoma and ocular hypertension. Timolol maleate ophthalmic solution 0.5% (timolol) Timolol is a beta-blocker drug for the reduction of intraocular pressure in open angle glaucoma and ocular hypertension. |
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