市郊区,GA (2016年4月26日) - Clearside生物医学公司. today announced that its Phase 2 clinical trial evaluating concomitant administration of suprachoroidal ZUPRATA™, Clearside’s proprietary form of triamcinolone acetonide, together with intravitreal aflibercept (EYLEA®), for the treatment of macular edema associated with retinal vein occlusion (RVO), 达到了主要终点. In preliminary results from the trial, patients in the active arm (those receiving concomitant administration of ZUPRATA and EYLEA) qualified for approximately 60% fewer intravitreal EYLEA treatments than those patients in the control arm who initially received EYLEA alone, during the three-month observation period following initial treatment (p=0.013). 审判, 被称为坦桑黝帘石, 是第一个被控制的, 戴面具的, randomized clinical trial conducted in patients with RVO, where drug was administered through the suprachoroidal space.
Secondary endpoints in the trial included the mean change from baseline in best corrected visual acuity (BCVA) and central subfield thickness. 对于BCVA端点, 在月1, patients in the active arm had an average improvement of approximately 16 letters in BCVA, or over three lines on a standard eye chart, compared to approximately 11 letters of improvement, 或者超过两行, 对于对照组的病人来说, each from their respective baseline measurements. At the end of the three-month observation period, patients in the active arm had an average improvement of approximately 19 letters, while patients in the control arm maintained their same level of improvement at approximately 11 letters.
In the secondary objective of measuring the central subfield thickness, 在月1, patients in both arms showed a mean reduction of over 400 µm. Patients in the active arm maintained this level of reduction throughout the three-month trial, while patients in the control arm had smaller levels of reduction as the trial progressed, with the mean reduction declining to approximately 340 µm 对于对照组的病人来说 beginning in month 2. 在安全方面, there were no serious adverse events reported in the trial and the treatment was generally well tolerated. Clearside plans on submitting the full data set for presentation at an upcoming medical meeting.
“The preliminary data from this clinical trial continue to provide support for the treatment of certain blinding eye diseases through suprachoroidal space administration of ZUPRATA and the potential for an effective and safe option for the treatment of RVO,丹尼尔·H说. White, CEO and President of Clearside. 基于这些结果, Clearside intends to follow a 505(b)(2) NDA regulatory approval pathway and expedite the preparations for a ZUPRATA Phase 3 registration program for the treatment of macular edema associated with RVO.”
RVO is a sight-threatening disorder resulting from the blockage of one of the veins carrying blood out of the retina. RVO is estimated to affect more than 16 million adults worldwide, according to a 2010 study published in the journal 眼科学, and it is estimated that RVO affects 2.2 million adults in the United States. 在RVO, the blockage of a retinal vein can lead to poor blood circulation, low oxygen and sometimes inflammation in the eye. A blocked vein will leak its contents of blood and fluid. Bleeding within the retina and swelling from the fluid can result in macular edema.
Clearside生物医学公司., 总部位于市郊区, GA, is a late-stage clinical biopharmaceutical company developing innovative first-in-class drug therapies to treat blinding diseases of the eye using Clearside’s proprietary suprachoroidal space (SCS™) microinjector to reach diseased tissue through the suprachoroidal space. Clearside holds intellectual property protecting the delivery of drugs of any type through the suprachoroidal space to reach the back of the eye. Clearside has a portfolio of clinical and pre-clinical programs using drug administration through the suprachoroidal space to provide a route of access to treat diseases of the back-of-the-eye like RVO, 葡萄膜炎, neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Clearside is currently enrolling patients in a Phase 3 clinical trial (Peachtree) for the treatment of patients with macular edema associated with non-infectious 葡萄膜炎 and has initiated IND-enabling studies for the treatment of wet AMD. 访问 www.clearsidebio.com 的更多信息.