杏輝(杏國) 505(b)(2) 黃斑部病變新藥 進FDA臨床phase III !!!

杏輝子公司杏國 治療黃斑部眼藥獲美FDA核准進入二、三期臨床   2012/4/18  鉅亨網  杏輝(1734)醫藥集團在新藥研發，也傳出喜訊！杏輝子公司杏國生技，已獲美國FDA核准，治療式老年性黃斑部病變(age-related macular degeneration, AMD)眼藥水新藥(SB04)，可在美執行第二、三期臨床試驗，同時杏國生技也將申請在台同步執行第二、三期臨床試驗。  杏輝指出，杏國生技去年(2011)與美國MacuCLEAR公司簽定投資股權協議，以策略聯盟方式獲得SB04眼藥水新藥於亞太區之臨床研發、生產製造及行銷等專屬經營權利外，未來將結合亞太區重要國家之合作伙伴，共同推動亞太區臨床試驗之執行，加速新藥核准上市。  根據世衛組織(WHO)統計，老年性黃斑部病變是導致老年失明的第三大原因(僅次於白內障及青光眼)，在台灣約有84萬名患者，而國際老年黃斑部病變聯盟（AMD Alliance International，AMDAI）於2010年報告中指出，全球約7.33億名低視力和失明患者的視力衰退治療成本約達3兆美元，其中乾式老年黃斑部病變病例約佔所有AMD病例的90%， 杏輝表示，目前尚未有對乾式AMD有效的治療藥物。   SB04眼藥水新藥屬舊藥新用，在美國FDA為505(b)(2)的快速審核(Fast track)藥物類型，此藥物因屬局部使用、非侵入性治療，且使用簡便，預估將可廣為醫生與病患接受。         

MacuCLEAR to initiate MC-1101 Phase III studies on early-stage AMD Published on April 12, 2012 at 12:10 AM·No Comments MacuCLEAR, Inc., a clinical stage specialty pharmaceutical company focused on discovering and developing novel solutions for vascular disorders of the eye, announced today it is beginning Phase III studies for its lead compound, MC-1101, for early-stage (Dry) age-related macular degeneration (AMD), based on positive feedback during the company's end-of-Phase II meeting with the FDA. MC-1101 is a proprietary, topically administered eye drop drug for treating and stopping the progression of AMD from the early-stage (Dry AMD) to the late-stage (Wet AMD) by increasing ocular blood flow in the choroidal vessels.  The first stage of MacuCLEAR's double-blinded Phase III study will examine 60 patients, using improvements in visual function as the trial's primary endpoint. "We're encouraged by the data generated for MC-1101 and are confident we'll meet the FDA's requirements set forth during our end-of-Phase II meeting," said MacuCLEAR president and CEO, Philip G. Ralston.  "We undoubtedly believe we're at the forefront of providing patients with AMD a means of preventing this terrible disease from advancing to its later stages."