Aerie治疗青光眼药物二期研究取得良好结果

Aeire制药公司最近宣布公司开发的治疗青光眼组合药物疗法Roclatan临床二期研究取得良好结果。公司即将着手准备即将进行的临床三期研究。Roclatan疗法主要是由Aerie公司处于研发阶段的药物Rhopressa和辉瑞公司治疗青光眼的长效药物latanoprost（Xalatan）组成。在这次为期28天有近300名患者参加的二期研究中，这一疗法表现出比latanoprost更令人满意的疗效。在研究中的第8、15、29天的三个时间点，青光眼患者眼内压数据比latanoprost超出1.6-3.2mmHg，具有明显统计学差异。公司计划不久即将开始进行关于Roclatan疗法的三次临床三期研究，招募患者志愿者总人数约1300。

详细英文报道：

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."