眼科治疗™根据特殊方案评估（SPA）获得美国食品药品监督管理局关于OTX-TKI治疗湿性AMD的首个关键临床试验的协议-动脉网

Ocular Therapeutix™ Receives FDA Agreement Under Special Protocol Assessment (SPA) for its First Pivotal Clinical Trial of OTX-TKI in Wet AMD

BioSpace 等信源发布 2023-11-01 14:07

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The first subject expected to be dosed by year-end

预计将在年底前给药的第一个主题

Company announces OTX-TKI trade name AXPAXLI

公司宣布OTX-TKI商标名AXPAXLI

BEDFORD, Mass., Nov. 01, 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 it had received written agreement regarding the overall design from the U.S.

马萨诸塞州贝德福德，2023年11月1日（GLOBE NEWSWIRE）-眼科治疗公司（纳斯达克股票代码：OCUL），一家专注于眼疾病和病症创新疗法的制定，开发和商业化的生物制药公司，今天宣布已收到美国整体设计的书面协议。

Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the Company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI (axitinib intravitreal implant), for the treatment of wet age-related macular degeneration (wet AMD), which the Company refers to as the SOL trial..

美国食品和药物管理局（FDA）根据一项特殊协议评估（SPA），针对该公司正在进行的关于AXPAXLI（axitinib玻璃体内植入物）的关键性3期临床试验，用于治疗湿性年龄相关性黄斑变性（湿性AMD）被称为SOL试验。。

The Company initiated the SOL trial in September 2023 and expects to enroll approximately 300 evaluable wet AMD subjects who are treatment naïve in the study eye in the trial. The SOL trial is designed to be a multi-center, parallel-group trial run primarily at U.S. sites, with subjects randomized to one injection of aflibercept or one implant of AXPAXLI followed by supplemental anti-VEGF treatment based on pre-specified criteria.

该公司于2023年9月启动了SOL试验，预计将招募约300名可评估的湿性AMD受试者，这些受试者在试验中在研究眼中未接受过治疗。SOL试验设计为主要在美国现场进行的多中心，平行组试验，受试者随机分为一次注射阿柏西普或一次植入AXPAXLI，然后根据预先设定的标准进行补充抗VEGF治疗。

With the agreement under the SPA, the Company will begin enrolling patients in the SOL trial and expects to dose the first subject by year-end..

根据SPA的协议，该公司将开始招募SOL试验中的患者，并预计将在年底前给予第一个受试者。。

About AXPAXLI

关于AXPAXLI

AXPAXLI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal diseases. AXPAXLI is also referred to by its laboratory code, OTX-TKI..

AXPAXLI是一种研究性生物可吸收水凝胶植入物，含有axitinib，一种具有抗血管生成特性的小分子多靶点酪氨酸激酶抑制剂，正在评估用于治疗湿性AMD和其他视网膜疾病。AXPAXLI也由其实验室代码OTX-TKI引用。。

About Wet AMD

关于湿性AMD

Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14 million individuals globally and 1.6 million in the United States alone (2022 Market Scope® Retinal Pharmaceuticals Market Report). Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF).

湿性年龄相关性黄斑变性（湿性AMD）是严重的，不可逆转的视力丧失的主要原因，影响全球约1400万人，仅在美国就有160万人（2022MarketScope®RetinalPharmaceuticals Market Report）。湿性AMD由于黄斑中异常的新血管生长和高通透性以及相关的视网膜血管分布而导致视力丧失，其主要由血管内皮生长因子（VEGF）的局部上调刺激。

Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include repeated intraocular injections every 1 to 4 months, treatment-related adverse events, patient compliance, and lack of vision improvement..

如果没有及时和持续的治疗来控制这种渗出活动，患者会出现不可逆转的视力丧失。通过适当的治疗，患者可能会在一段时间内保持视觉功能，并可能暂时恢复视力丧失。目前治疗的挑战包括每1至4个月重复眼内注射，治疗相关不良事件，患者依从性和视力改善不足。。

About Ocular Therapeutix, Inc.

关于眼科治疗公司。

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology ELUTYX™. Ocular Therapeutix’s first commercial drug product, DEXTENZA®, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix，Inc。是一家生物制药公司，专注于使用其专有的基于生物可吸收水凝胶的配方技术ELUTYX为眼睛疾病和病症的创新疗法的配制，开发和商业化™. Ocular Therapeutix的第一个商业药品DEXTENZA®是FDA批准的皮质类固醇，用于治疗眼科手术后的眼部炎症和疼痛以及与过敏性结膜炎相关的眼部瘙痒。

Ocular Therapeutix’s earlier stage development assets include: AXPAXLI (axitinib intravitreal implant), currently in a pivotal Phase 3 trial for wet AMD and a Phase 1 clinical trial for the treatment of diabetic retinopathy; OTX-TIC (travoprost intracameral implant), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease, both of which have completed Phase 2 clinical trials..

Ocular Therapeutix的早期开发资产包括：AXPAXLI（axitinib玻璃体内植入物），目前处于湿性AMD的关键阶段3试验和治疗糖尿病视网膜病变的1期临床试验；OTX-TIC（travoprost前房内植入物），目前正处于治疗原发性开角型青光眼或高眼压症的2期临床试验中；和OTX-CSI（环孢菌素颅内插入物）用于慢性治疗干眼症和OTX-DED（地塞米松颅内插入物）用于短期治疗干眼症的体征和症状，两者均已完成2期临床试验。。

Forward Looking Statements

前瞻性声明

Any statements in this press release about future expectations, plans, and prospects for the Company, including the development and regulatory status of the Company’s product candidates, including the timing, design, and enrollment of the Company’s pivotal trials of AXPAXLI (also called OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI; the Company’s cash runway and sufficiency of the Company’s cash resources; and other statements containing the words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend', 'goal,' 'may', 'might,' 'plan,' 'predict,' 'project,' 'target,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'continue,' and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

本新闻稿中有关公司未来预期，计划和前景的任何声明，包括公司产品候选人的发展和监管状况，包括公司AXPAXLI（也称为OTX-TKI）关键试验的时间，设计和注册）用于治疗湿性AMD；公司计划推进AXPAXLI的发展；公司的现金跑道和公司现金资源的充足性；以及其他包含“预期”，“相信”，“估计”，“期望”，“意图”，“目标”，“可能”，“可能”，“计划”，“预测”，“项目”，“目标”，“潜力”，“将会”，“可能”，“应该继续”和类似的表述，构成了1995年“私人证券诉讼改革法”含义内的前瞻性陈述。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.

由于各种重要因素，实际结果可能与此类前瞻性陈述所表明的结果大不相同。此类前瞻性陈述涉及可能导致公司临床前和临床开发计划，未来结果，绩效或成就与前瞻性陈述中表达或暗示的重大风险和不确定性。

Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA or any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval; the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA; the initiation, design, timing, conduct and outcomes of clinical trials, including the SOL trial; the risk that the FDA will not agr.

这些风险和不确定性包括DEXTENZA或任何获得监管部门批准的产品或候选产品商业化所涉及的时间和成本；保留DEXTENZA或任何获得监管批准的产品或候选产品的监管批准的能力；DEXTENZA的产品，程序和任何其他报销代码的维护能力和充分性；包括SOL试验在内的临床试验的启动，设计，时间安排，实施和结果；FDA不会agr的风险。

Investors

投资者

Ocular Therapeutix

眼疗法

Donald Notman

唐纳德·诺特曼

Chief Financial Officer

首席财务官

dnotman@ocutx.com

或

ICR Westwicke

Chris Brinzey, 339-970-2843