BEDFORD, Mass., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye, today announced the initiation of its first pivotal clinical trial to evaluate OTX-TKI, the Company’s axitinib intravitreal implant, for the treatment of wet age-related macular degeneration (wet AMD).

马萨诸塞州贝德福德，2023年10月3日（GLOBE NEWSWIRE）-生物制药公司Ocular Therapeutix，Inc。（纳斯达克股票代码：OCUL），专注于眼疾病和病症创新疗法的制定，开发和商业化，今天宣布启动其首个关键临床试验，以评估该公司的axitinib玻璃体内植入物OTX-TKI，用于治疗湿性年龄相关性黄斑变性（湿性AMD）。

OTX-TKI is also being developed for the treatment of diabetic retinopathy and other retinal diseases. 'We are thrilled to announce the initiation of our pivotal trial evaluating OTX-TKI for the treatment of wet AMD and look forward to working with clinical sites across the US,' said Antony Mattessich, CEO of Ocular Therapeutix.

OTX-TKI也正在开发用于治疗糖尿病视网膜病变和其他视网膜疾病Ocular Therapeutix首席执行官安东尼·马特西奇（Antony Mattessich）说，我们很高兴宣布启动我们评估OTX-TKI治疗湿性AMD的关键试验，并期待与美国各地的临床站点合作。

“With the activation of our first clinical site in the US, we believe we are on target to enroll our first subject before year end. The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss.' Ocular Therapeutix has requested a Special Protocol Assessment (SPA) from the U.S.

“随着我们在美国的第一个临床站点的激活，我们相信我们的目标是在年底之前注册我们的第一个主题。这项试验是我们临床计划迈出的关键一步，因为我们朝着实现变革性的目标取得进展新的治疗方法，可以真正为应对视力丧失的患者带来湿性AMD的不同。“眼科治疗需要一个特殊的来自美国的协议评估（SPA）。

Food and Drug Administration (FDA) regarding the design of the trial, which is designed as a superiority trial that will enroll approximately 300 evaluable wet AMD subjects who are treatment naïve in the study eye. The trial is designed to be a multi-center, parallel-group trial that will be run primarily at U.S.

美国食品药品监督管理局（FDA）关于该试验的设计，该试验被设计为一项优越性试验，将招募约300名在研究眼中未接受过治疗的可评估湿性AMD受试者。该试验设计为多中心、平行组试验，主要在美国进行。

sites with subjects randomized to one injection of aflibercept or one implant of OTX-TKI followed by as needed supplemental anti-VEGF treatment based on pre-specified criteria. The safety and efficacy of OTX-TKI will be assessed by measuring best corrected visual acui.

受试者随机接受一次阿柏西普注射或一次OTX-TKI植入，然后根据需要根据预先设定的标准进行补充抗VEGF治疗。OTX-TKI的安全性和有效性将通过测量最佳矫正视力来评估。