Roclatan meets primary efficacy endpoint in phase 3 study

Roclatan, a once-daily fixed-dose combination drug for lowering IOP, has achieved its primary efficacy endpoint in the Mercury 2 phase 3 study, Aerie Pharmaceuticals announced in a press release.The 90-day trial compared Roclatan — a combination of Rhopressa (netarsudil ophthalmic solution 0.02%) and latanoprost — with monotherapy of each of its components. IOP was measured three times daily at 2 weeks, 6 weeks and 90 days. Roclatan reduced IOP between 1.5 mm Hg and 2.4 mm Hg more than latanoprost alone and between 2.2 mm Hg and 3.3 mm Hg (Read more...)

ClearSight’s parent company acquired by China-based firm

Sharklet Technologies, the parent company of ClearSight, has been acquired by the China-based equity medical device firm Peaceful Union, ClearSight announced in a press release.“We believe that the biomimetic approach used by Sharklet Technologies will not only produce the most advanced IOL, but will most likely enhance the performance of a wide range of ophthalmic products,” Khalid “Kal” Mentak, PhD, CEO of ClearSight, said in the release.


米兰–(BUSINESS WIRE)–(美国商业资讯) — 生物制药公司Dompé今天宣布,EMA(欧洲药品署)人用药品委员会(CHMP)发布了一项肯定意见,建议签发Oxervate®(cenegermin 滴眼液)用于治疗中度或重度神经营养性角膜炎成人患者的上市许可。该病是一种罕见的致残性眼病,可导致失明。迄今,该病缺乏满意的治疗方法。鉴于该病相关的风险及缺乏有效治疗选择,CHMP通过加速评估完成了审批。加速评估始于2016年11月,本周以肯定意见收尾。 神经营养性角膜炎的起源与三叉神经(负责眼解剖和功能的神经之一)损害有关,该损害可导致角膜敏感性丧失。该病最严重时可导致溃疡、溶解和角膜穿孔,影响患者的视力2。 若获得EMA孤儿药品委员会(COMP)证实及欧盟核准,Oxervate®将是世界上首个获准用于该适应证的生物技术孤儿药。 该活性药物的名称是Cenegermin,是人类神经生长因子(NGF)的重组版本,发现者是诺贝尔奖获得者Rita Levi Montalcini。该蛋白质由人体天然产生,参与神经细胞的发育、维护和生存3。Oxervate®以滴眼液的形式施用于神经营养

Congressional Budget Office estimates $119 billion in savings over 10 years for House-passed AHCA

The Congressional Budget Office — a non-partisan scoring agency — and the staff of the Joint Committee on Taxation released its cost estimate for the House-passed version of the American Health Care Act and estimated $119 billion in net savings from 2017 to 2026 for the proposed health care plan. Republicans needed the bill to shave off $2 billion from the federal deficit over the decade span for it to be considered under the reconciliation process in the Senate.

Aerie Pharmaceuticals Reports Positive Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 Topline Efficacy Results

IRVINE, Calif.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported the successful primary efficacy results of the Company’s 90-day Phase 3 “Mercury 2” registration trial for its fixed-dose combination product candidate, Roclatan™. The results of Mercury 2 were consistent