Aerie Pharmaceuticals Announces Acceptance of Its Investigational New Drug Application for AR-1105 (Dexamethasone Intravitreal Implant)

Aerie Pharmaceuticals 公司 AR -1105新药临床研究申请获批

2019-01-18 08:40:00 BioSpace

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Phase 2 Clinical Study Initiating Later in First Quarter 2019 DURHAM, N.C.--(BUSINESS WIRE)-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retina diseases and other diseases of the eye today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug Application (IND) for AR-1105 (dexamethasone intravitreal implant) and it is now in effect, allowing Aerie to initiate human studies in the treatment of macular edema due to retinal vein occlusion (RVO). The IND was submitted in December 2018. Aerie expects to initiate a Phase 2 clinical study later in the first quarter of 2019. AR-1105 is a bio-erodible implant that is designed to release the steroid dexamethasone over a six-month sustained period. The method of administration is through commonly used intravitreal injection. The potential benefits of AR-1105 compared to other steroid products include six-month duration of efficacy, improved administration due to a smaller needle size, and possibly a better safety profile due to lower peak drug levels. “AR-1105 is the first IND-stage treatment in Aerie’s retina pipeline, which is an important milestone for the company,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “This quarter we also plan to file an IND for our second retina product, a bio-erodible implant containing the Rho kinase/Protein kinase C inhibitor AR-13503 that is being developed for wet age-related macular degeneration and diabetic macular edema. These products demonstrate the potential of our two enabling platforms for delivering drugs to the back of the eye, the bio-erodible polymer technology we licensed from DSM and the PRINT® manufacturing technology licensed from Envisia. As we advance these new treatments in our second significant therapeutic area in eye care, we continue to pursue our goal of building the next major ophthalmic pharmaceutical company.” About Aerie Pharmaceuticals, Inc. Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retina diseases and other diseases of the eye. Aerie's first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a once-daily eyedrop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa®, the most common adverse reactions were conjunctival hyperemia, cornea verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa®, including the product label, is available at www.rhopressa.com. Aerie’s advanced-stage product candidate, Rocklatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a fixed-dose combination of Rhopressa® and the widely-prescribed PGA (prostaglandin analog) latanoprost, achieved its 3-month primary efficacy endpoint in two Phase 3 registration trials, Mercury 1 and Mercury 2, and also showed safety and efficacy throughout 12 months in Mercury 1. Aerie submitted the Rocklatan™ New Drug Application (NDA) in May 2018 and, in July 2018, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Rocklatan™ NDA for March 14, 2019. Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com. Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our expectations regarding the commercialization and manufacturing of Rhopressa® and Rocklatan™ or any future product candidates, including the timing, cost or other aspects of the commercial launch of Rhopressa® and Rocklatan™ or any future product candidates; our commercialization, marketing, manufacturing and supply management capabilities and strategies; the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for Rhopressa®, with respect to regulatory approval outside of the United States or additional indications, and Rocklatan™ or any future product candidates, including statements regarding the timing of initiation and completion of the studies and trials, such as statements in this press release regarding any expected clinical trials for AR-1105 or AR-13503 and results of such clinical trials; the timing of and our ability to request, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, as applicable, Rhopressa®, Rocklatan™ or any future product candidates, including the expected timing of, and timing of regulatory and/or other review of, filings for, as applicable, Rhopressa®, Rocklatan™ or any future product candidates; the potential advantages of Rhopressa® and Rocklatan™ or any future product candidates; our plans to pursue development of additional product candidates and technologies within and beyond ophthalmology; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma, including development of our retina program; our ability to protect our proprietary technology and enforce our intellectual property rights; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products, product candidates or technologies. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, industry change and other factors beyond our control, and depend on regulatory approvals and economic and other environmental circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). In particular, FDA approval of Rhopressa® does not constitute FDA approval of Rocklatan™, and there can be no assurance that we will receive FDA approval for Rocklatan™, AR-1105, AR-13503 or any future product candidates. FDA approval of Rhopressa® also does not constitute regulatory approval of Rhopressa® in jurisdictions outside the United States and there can be no assurance that we will receive regulatory approval for Rhopressa® in jurisdictions outside the United States. Our receipt of a Prescription Drug User Fee Act (PDUFA) goal date notification for Rocklatan™ does not constitute FDA approval of the Rocklatan™ New Drug Application (NDA), and there can be no assurance that the FDA will complete its review by the PDUFA goal date of March 14, 2019, that the FDA will not require changes or additional data that must be made or received before it will approve the NDA, if ever, or that the FDA will approve the NDA. In addition, the acceptance of the IND discussed in this press release does not constitute FDA approval of AR-1105 and the outcome of later clinical trials for AR-1105 may not be sufficient to submit an NDA with the FDA or to receive FDA approval. Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. View source version on businesswire.com: https://www.businesswire.com/news/home/20190117005165/en/ Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com Source: Aerie Pharmaceuticals, Inc. View this news release online at: http://www.businesswire.com/news/home/20190117005165/en
第二期临床研究于二零一九年第一季后期展开 DuRHAM , N.C .--- Aerie Pharmaceuticals , Inc .( NASDAQ : AERI )是一家眼科制药公司,专注于发现、开发和商业化治疗开角型青光眼,视网膜疾病和其他眼部疾病的首创新药疗法。该公司今天宣布,美国食品和药物管理局(食品药品监督管理局(FDA))已经审查了 AR-1105(玻璃体内地塞米松植入物)的新药临床研究申请( IND ),现在已经生效,允许 Aerie 启动关于视网膜静脉阻塞引起的黄斑水肿( RVO )试验。IND 于2018年12月提交。Aerie 预计将在2019年第一季度晚些时候启动第二期临床研究。 AR-1105是一种可生物溶解的植入物,其目的是在6个月的持续时间内释放类固醇地塞米松。给药方法是通过常用的玻璃体内注射。与其他类固醇产品相比, AR-1105的潜在益处包括六个月的疗效持续时间、由于针头尺寸较小而改进的给药以及由于药物水平较低而可能具有更好的安全性。 “ AR-1105是 Aerie 视网膜管道的第一个 IND 阶段治疗,这是该公司的一个重要里程碑,” Aerie 董事长兼首席执行官 Vicente Anido Jr .博士说。“这个季度我们还计划为我们的第二个视网膜产品,一个可生物溶解的植入物,包含 Rho 激酶/蛋白激酶 C 抑制剂 AR-13503,该药正在开发中,主要针对湿性年龄相关性黄斑变性和糖尿病黄斑水肿。这些产品展示了我们两个支持平台向眼后部交付药物的潜力,我们从 DSM 许可的生物可腐蚀聚合物技术,以及从 Envisia 许可的 PRINT ®制造技术。随着我们在眼科医疗的第二个重要治疗领域推进这些新的治疗方法,我们继续追求建立下一个主要眼科制药公司的目标。” 关于 Aerie Pharmaceuticals , Inc . Aerie 公司是一家眼科制药公司,专注于发现、开发和商业化用于治疗开角型青光眼、视网膜疾病等眼科疾病的一流疗法。Aerie 公司的第一个产品 Rhoplessa ®( netarusudi 眼科溶液)0.02%,即美国食品和药物管理局(食品药品监督管理局(FDA))批准的用于降低开角型青光眼或高眼压患者眼压升高(眼压(IOP))的每日一次的滴眼液,已于2018年4月在美国上市。在 Rhoplessa ®的临床试验中,最常见的不良反应是结膜充血、角膜垂直凸起、灌注部位疼痛和结膜出血。有关 Rhoplessa ®的更多信息,包括产品标签,请访问 www.rhpressa.com.Aerie 的高级产品候选者 Rockllatan ™( netarsudi / latano前列腺素眼科溶液)0.02%/0.005%, Rhoplassa ®和广开处方的 PGA (前列腺素类似物) latano前列腺素的固定剂量组合,在 Mercury 1和 Mercury 2两个3期注册试验中实现了3个月的主要疗效终点,并在 Mercury 1的12个月中显示了安全性和有效性。Aerie 于2018年5月提交了 Rocklatian ™新药申请( NDA ),2018年7月, FDA 设定了 PDUFA (处方药用户费用法案)目标日期,以完成食品药品监督管理局(FDA)对 Rockllatan ™ NDA 2019年3月14日的审查。Aerie 继续专注于全球扩张和眼科学领域其他产品候选和技术的开发,包括湿性年龄相关性黄斑变性和糖尿病黄斑水肿。更多信息见 www.aeriepharma.com 。 前瞻性陈述 本新闻稿包含前瞻性声明,目的是为安全港口的规定,私人证券诉讼改革法案1995年。在某些情况下,我们可能会使用诸如“预测”、“相信”、“潜力”、“提议”、“继续”、“估计”、“预期”、“预期”、“计划”、“可能”、“可能”、“可能”、“可能”、“将”、“应该”、“探索”、“追求”等术语,或者其他表达未来事件或结果不确定性的词语来识别这些前瞻性陈述。前瞻性声明包括有关我们的意图、信念、预测、展望、分析或当前预期的声明,其中包括:我们对 Rhoplessa ®和 Rocklatian ™的商业化和制造的预期或任何未来产品候选者的预期,包括时间安排、Rhoplassa ®和 Rocklatian ™的商业上市或任何未来产品候选者的成本或其他方面;我们的商业化、营销、制造和供应管理能力和战略; Rhoplassa ®持续和预期的临床前研究和临床试验的成功、时间和成本,涉及美国以外的监管批准或其他适应症,以及 Rocklatian ™或任何未来产品候选者,包括关于开始和完成研究和试验的时间安排的声明,例如本新闻稿中关于 AR-1105或 AR-13503的任何预期临床试验以及此类临床试验的结果的声明;要求、获得和维持食品药品监督管理局(FDA)或其他监管机构批准的时间以及我们的能力,或与 Rhoplessa ®、 Rockllatan ™或任何未来产品候选者相关的其他行动;包括适用的 Rhoplessa ®的预期提交时间和监管和/或其他审查的时间,Rocklatian ™或任何未来产品候选者; Rhoplassa ®和 Rocklatian ™或任何未来产品候选者的潜在优势;我们计划在眼科学内外开发更多产品候选者和技术;我们计划探索青光眼以外现有专利化合物的可能用途,包括开发视网膜计划;我们保护专有技术和强制实施知识产权的能力;以及我们对战略运营的预期,包括我们许可或获取额外眼科产品、产品候选者或技术的能力。根据其性质,前瞻性陈述涉及风险和不确定性,因为它们涉及事件、竞争动态、行业变化和我们无法控制的其他因素。以及取决于将来可能发生或不会发生或可能发生的时间比预期长或短的监管批准以及经济和其他环境情况。我们在向美国证券交易委员会( SEC )提交的季度和年度报告中,在“风险因素”标题下更详细地讨论了其中的许多风险。特别是, Rhoplassa ®的 FDA 批准不构成 Rocklatian ™的食品药品监督管理局(FDA)批准,也不能保证我们将获得 Rocklatian ™、 AR-1105、 AR-13503或任何未来产品候选者的 FDA 批准。美国食品药品监督管理局(FDA)批准 Rhoplessa ®也不构成 Rhoplessa ®在美国以外的司法辖区的监管批准,也不能保证我们将在美国以外的司法辖区获得 Rhoplessa ®的监管批准。我们收到 Rocklatian ™的处方药用户费法( PDUFA )目标日期通知并不构成 FDA 对 Rocklatian ™新药申请( NDA )的批准,也不能保证食品药品监督管理局(FDA)在 PDUFA 目标日期2019年3月14日之前完成其审查。FDA 不会要求在批准 NDA 之前必须做出或接收的更改或附加数据,或者食品药品监督管理局(FDA)将批准 NDA 。此外,本新闻稿中讨论的接受 IND 不构成 FDA 对 AR-1105的批准, AR-1105的后期临床试验结果可能不足以向 FDA 提交 NDA 或获得食品药品监督管理局(FDA)批准。前瞻性陈述并不能保证未来业绩及我们的实际经营业绩、财务状况及流动资金,而我们经营所在行业的发展可能与本新闻稿所载的前瞻性陈述存在重大差异。我们在本新闻稿中所作的任何前瞻性陈述仅在本新闻稿发布之日起发表。我们不承担任何义务更新我们的前瞻性声明,无论是由于新的信息,未来事件或其他,在本新闻稿日期之后。 查看 businesswire 上的源代码。com : https://www.businesswire.com/news/home/20190117005165/en/ 媒体: Tad Heitmann 949-526-8747; itmann @ aeriepharma.com 投资者: Ami Bavishi 908-947-3949; abavisihi @ aeriepharma.com 资料来源: Aerie Pharmaceuticals , Inc . 在线查看本新闻发布会,网址为: http://www.businesswire.com/news/home/20190117005165/en

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