2014年6月26日訊 /生物谷BIOON/ --Aeire製藥公司最近宣布公司開發的治療青光眼組合藥物療法Roclatan臨床二期研究取得良好結果。公司即將著手準備即將進行的臨床三期研究。Roclatan療法主要是由Aerie公司處於研發階段的藥物Rhopressa和輝瑞公司治療青光眼的長效藥物latanoprost（Xalatan）組成。在這次為期28天有近300名患者參加的二期研究中，這一療法表現出比latanoprost更令人滿意的療效。在研究中的第8、15、29天的三個時間點，青光眼患者眼內壓數據比latanoprost超出1.6-3.2mmHg，具有明顯統計學差異。公司計劃不久即將開始進行關於Roclatan療法的三次臨床三期研究，招募患者志願者總人數約1300。（生物谷Bioon.com）
詳細英文報導：
Aerie Pharmaceuticals says that a combo glaucoma drug adding its own treatment to the best-selling standard in the field topped the blockbuster solo therapy in a Phase IIb trial. The results set the stage for a confirmatory Phase III trial, sending its share price ($AERI) soaring more than 40% on Wednesday morning.
Roclatan is made up of Aerie's experimental drug Rhopressa (AR-13324) and latanoprost, a popular glaucoma drug sold as Xalatan by Pfizer ($PFE), which brings in more than a billion dollars a year. These drugs are designed to address the ocular hypertension behind glaucoma, and investigators for Aerie say that they tracked statistically significant responses for the combo. Close to 300 patients were enrolled for the 28-day study.
Aerie went public last fall, joining a mob of biotechs moving into the public markets and pitching the potential of AR-13324.
"Roclatan efficacy exceeded that of latanoprost, the most widely prescribed glaucoma drug, by 1.6 to 3.2 mmHg across each time point evaluated during the study (8am, 10am, 4pm on days 8, 15 and 29)," the company noted. "These results were statistically significant at all time points with p-values less than 0.05."
Aerie has now mapped out plans for three late-stage studies, with plans to enroll about 1,300 patients.
"We are very impressed by the Roclatan Phase IIb results," says Aerie CEO Vicente Anido. "This product has demonstrated great promise to potentially become the most effective IOP-lowering product on the market, creating new hope for glaucoma sufferers. With this success we believe we have an approvable product, and Phase III preparatory activities for Roclatan are commencing immediately. The entire Aerie team remains focused on moving forward towards Phase III registration trials for Roclatan, and initiating the Phase III registration trials for our other innovative product, triple-action Rhopressa."