Vorolanib

WATERTOWN, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced the closing of its previously announced underwritten public offering of 14,636,363 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock, at the public offering price of $11.00 per share. Gross proceeds to EyePoint in the offering, before underwriting discounts and estimated expenses of the offering, were approximately $161.0 million. J.P. Morgan, Citigroup and Guggenheim Securities acted as joint book running managers for the offering. Baird, Mizuho and Jones acted as co-managers for the offering. EyePoint intends to use the net proceeds from the offering to advance clinical development of DURAVYU™ for wet age related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as support its earlier stage pipeline development initiatives, and for general corporate purposes. The securities described above were offered by EyePoint pursuant to a shelf registration statement on Form S-3 (No. 333-281391) previously filed with the Securities and Exchange Commission (SEC) on August 8, 2024 and declared effective by the SEC on August 16, 2024. The securities were offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A final prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ (f/k/a EYP-1901), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet AMD, the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in DME. EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026. Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the anticipated use of proceeds for the offering, EyePoint’s clinical development plans and the expected timing thereof; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy; the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. More detailed information on these and additional factors that could affect EyePoint’s actual results are described in EyePoint’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. All forward-looking statements in this news release speak only as of the date of this news release. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investors:Christina TartagliaPrecision AQ (formerly Stern IR)Direct: 212-698-8700christina.tartaglia@sternir.com Media ContactAmy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@greenroompr.com

美国马萨诸塞州沃特敦时间10月28日，公司合作伙伴EyePoint Pharmaceuticals, Inc.（EyePoint）在官网发布新闻①，公布了伏罗尼布玻璃体内植入剂（DURAVYUTM）治疗糖尿病黄斑病变（DME）的II期临床试验VERONA研究的积极的16周中期数据，该试验尚在进行中。 与阿柏西普对照组相比，DURAVYU 2.7mg组的最佳矫正视力（BCVA）和组织学上的疾病控制能力均呈现较好的早期、持续且具有临床意义的改善。DURAVYU的两个剂量组均保持良好的安全性和耐受性。 截至2024年10月1日，II期临床试验VERONA研究的16周中期数据如下： 所有患者（n=27）均完成了第16周的随访 通过光学相干断层扫描（OCT）测量，DURAVYU 2.7mg组表现出BCVA和中央视网膜厚度（CST）的早期且持续的改善 BCVA：与基线相比，DURAVYU 2.7mg组改善了8.9个字母，阿柏西普对照组改善了3.2个字母 CST：与基线相比，DURAVYU 2.7mg组改善了68.1微米，阿柏西普对照组改善了30.5微米 在第4周时观察到视觉和组织学方面的改善，表明DURAVYU具有即时的生物利用度 在第24周随访的患者中，BCVA和组织学方面持续呈现积极趋势 持续保持良好的安全性和耐受性，没有DURAVYU相关的眼部或者全身严重不良事件（SAE）。此外没有出现以下病例：眼内炎、视网膜血管炎（闭塞性或非闭塞性）、植入剂位移至前房、眼内炎症（IOI） 在第16周时，DURAVYU 2.7mg组82%的受试眼无需补充治疗，而阿柏西普对照组仅50%的受试眼无需补充治疗 VERONA研究是一项随机、对照、单盲、开放标签的II期临床试验，治疗既往接受过标准抗VEGF治疗的DME患者。 ●该试验招募了27例患者，他们被分配至DURAVYU 1.3mg组、DURAVYU 2.7mg组或者阿柏西普对照组。 ●VERONA研究的主要疗效终点是根据既定的补充治疗标准，在24周内至首次接受阿柏西普补充治疗的时间。 ●关键次要终点包括安全性、BCVA的平均变化、OCT测量的CST的平均变化以及糖尿病视网膜病变严重程度量表（DRSS）随时间的变化。 关于DURAVYUTM DURAVYUTM，曾用名EYP-1901，有望为VEGF介导的视网膜疾病提供新的治疗方式。DURAVYU通过EyePoint专有的缓释技术Durasert ETM，将伏罗尼布制剂为固体可生物降解的植入剂进行药物递送。伏罗尼布是一款有选择性且经专利保护的酪氨酸激酶抑制剂（TKI），其作为pan-VEGF受体抑制剂，能抑制所有的VEGF受体，为VEGF介导的视网膜疾病带来了一种新的机制方法。此外，在视网膜脱离的体内模型中，伏罗尼布显示出神经保护作用和潜在的抗纤维化作用。DURAVYU能够在室温条件下储存和运输，便于门诊给药。该产品能即刻释放药物，可快速生物利用，并实现约9个月的近似恒速释放。 DURAVYU在治疗湿性年龄相关性黄斑变性（wAMD）的I期临床试验DAVIO研究和II期临床试验DAVIO 2研究中均已获得积极的具有临床意义的疗效数据，即视力和CST稳定且有良好的安全性。此外，DAVIO 2研究的临床数据显示，在DURAVYU治疗6个月后，患者的治疗负担降低约88%，超过80%的患者不需要或者仅接受一次补充治疗。DAVIO 2研究的临床数据支持了wAMD适应症研究的推进和III期临床试验LUGANO研究的启动，关键临床试验LUCIA研究也将在2024年底启动。 DURAVYU同时也在进行治疗DME的II期临床试验VERONA研究，预计在2025年第一季度获得完整的主要数据。 新闻原文及本篇引用数据链接如下： ①https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-announces-positive-interim-16-week-data ②有关该试验的更多信息，请访问 clinicaltrials.gov（试验识别号：NCT06099184）