Vorolanib

- Primary endpoint achieved by both DURAVYU doses (1.34mg and 2.7mg) with extended time to first supplemental injection versus aflibercept control – - DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a 24-week gain of +7.1 letters and anatomical improvement of 76 microns reduction in CST paired with reduction in treatment burden of two-thirds – Favorable safety profile continues with no DURAVYU-related ocular or systemic SAEs – – Phase 3 non-inferiority pivotal program initiation anticipated by the end of 2025 – – Conference call to be held today, February 5, 2025 at 8:00 a.m. ET – Feb. 05, 2025 -- 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 positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor (TKI) formulated in proprietary bioerodible Durasert E™. The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for both DURAVYU doses. The trial also demonstrated clinically meaningful outcomes including continued safety with no DURAVYU-related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control. DURAVYU 2.7mg demonstrated a +7.1 letter BCVA gain and 76-micron CST reduction at week 24, with a supplement-free rate of 73% versus 50% for eyes treated with aflibercept. These positive Phase 2 VERONA results add to a robust dataset across another key indication demonstrating the best-in-class potential for DURAVYU in serious retinal diseases. “We are extremely pleased to report these highly positive VERONA results that demonstrate 2.7mg DURAVYU immediately and meaningfully improves both visual acuity and anatomy in DME patients with a superior dosing interval and excellent safety. This underscores the potential of DURAVYU to be a best-in-class treatment for patients,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “DME is the leading cause of vision loss in working age adults and the second largest market in retinal diseases after wet age-related macular degeneration (wet AMD). The data from the VERONA trial demonstrate that after a single DURAVYU 2.7mg treatment there was an early and maintained improvement in both BCVA and retinal thickening as measured by OCT throughout the six-month trial, demonstrating the differentiated profile of DURAVYU with immediate bioavailability and zero order kinetics drug delivery. Importantly, the favorable safety and tolerability profile of DURAVYU continued with no DURAVYU-related ocular or systemic serious adverse events. These compelling results support a noninferiority pivotal program in DME, and we plan to meet with the FDA in the second quarter for potential initiation of a Phase 3 clinical trial later in 2025. With ongoing pivotal trials in wet AMD on track to read-out in 2026 and positive efficacy and safety data across multiple Phase 2 clinical trials, DURAVYU is well-positioned to become a potential blockbuster franchise.” Both DURAVYU doses (1.34 mg and 2.7mg) met the primary endpoint of extended time to first supplemental injection versus aflibercept control. DURAVYU 2.7mg demonstrated an early and sustained improvement in both best corrected visual acuity (BCVA) and central subfield thickness (CST) as measured by optical coherence tomography (OCT). BCVA improved +7.1 letters compared to baseline. CST improved 75.9 microns compared to baseline representing 74% more drying in DURAVYU eyes versus aflibercept control. Visual and anatomical gains were observed at Week 4 demonstrating the immediate bioavailability of DURAVYU. 73% of eyes in the DURAVYU 2.7mg arm were supplement-free versus 50% in the aflibercept control arm up to week 24 underscoring that the positive efficacy results were driven by treatment with DURAVYU and not supplemental injections. Over two-thirds reduction in treatment burden for 2.7mg dose. DURAVYU favorable safety profile continues: No DURAVYU-related ocular or systemic serious adverse events reported No cases of: Impaired vision Endophthalmitis Retinal vasculitis (occlusive or non-occlusive) Insert migration Intraocular inflammation (IOI) “DME is a prevalent disease with a significant need for more durable treatments,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer. “The data from the Phase 2 VERONA trial demonstrated that within four weeks, eyes treated with DURAVYU had a significant benefit for patients with DME, both visually and anatomically. The magnitude of these results gives us confidence moving forward into a Phase 3 noninferiority program with a differentiated treatment for patients with DME who need effective, safe and durable treatment options. We would like to thank the patients, investigators and their staff for participating in the trial, and we look forward to working with regulatory agencies to discuss next steps as we work to advance this innovative therapy and improve the lives of patients suffering from serious retinal diseases.” “The diabetes epidemic and the associated increase in patients with DME has resulted in a significant burden to patients and the healthcare system,” said Carl Regillo, M.D., FACS, Chief of Retina Service at Wills Eye Hospital and Co-Chair of EyePoint’s SAB. “The number of diabetic retinopathy patients is predicted to reach 16 million by 2050, and diabetes-related vision loss is expected to cost 500 million US dollars annually. The average patient with DME is working age and requires burdensome monthly injections that can result in missed visits and chronic undertreatment. This can lead to irreparable vision loss and potential blindness. I am very encouraged by the Phase 2 VERONA data demonstrating the ability to improve vision and anatomy while maintaining a favorable safety and tolerability profile. Additionally, DURAVYU features zero order kinetics release, so the VEGF receptors remain blocked for at least six months enabling the ability to extend dosing intervals while maintaining the patient’s vision. This feature will be important in the DME population, giving patients and physicians a durable treatment option. Based on these meaningful Phase 2 results, I believe DURAVYU demonstrates the ability to fundamentally alter the treatment paradigm in DME, and if approved, has the potential for significant adoption among retina specialists.” VERONA is a randomized, controlled, single-masked, open label Phase 2 trial of DURAVYU in DME patients previously treated with a standard-of-care anti-VEGF therapy. The trial enrolled 27 patients assigned to one of two intravitreal doses of DURAVYU (1.34mg or 2.7mg) or aflibercept control. The primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria. Key secondary endpoints include safety, mean change in best corrected visual acuity (BCVA), mean change in central subfield thickness (CST) as measured by optical coherence tomography (OCT) and change in diabetic retinopathy severity scale (DRSS) over time. More information about the trial is available at clinicaltrials.gov (identifier: NCT06099184). The 16-week interim data will be presented at Angiogenesis, Exudation, and Degeneration 2025 in February and the full six-month data at an upcoming medical meeting. Diabetic macular edema (DME) is the leading cause of vision loss in people with type 1 and type 2 diabetes. DME results when damaged blood vessels leak fluid into the macula, the central portion of the retina responsible for the sharp vision needed for routine tasks such as driving or reading. This resulting retinal swelling can cause blurred vision and may lead to severe vision loss or even blindness. DME is a common form of sight-threatening retinopathy in people with diabetes, with approximately 28 million people afflicted worldwide. As the prevalence of diabetes continues to grow, an increased number of people will be affected by diabetic eye diseases such as DME. The current standard of care for patients experiencing DME includes intravitreal injections of short-acting anti-VEGF biologics, corticosteroids, or laser photocoagulation which can become a burden on patients, caregivers, and physicians due to the longevity of the disease. DURAVYU™, f/k/a EYP-1901, is being developed as a potential sustained-delivery maintenance treatment for patients suffering from chronic VEGF-mediated retinal diseases. DURAVYU delivers vorolanib, a differentiated and patent-protected tyrosine kinase inhibitor (TKI), as a solid bioerodible insert using EyePoint’s proprietary and best-in-class bioerodible Durasert E™ technology. Vorolanib brings a new mechanism of action to the treatment of VEGF-mediated retinal diseases as a potent and highly selective pan-VEGF receptor inhibitor. Benefits of this new mechanistic approach include the demonstration of neuroprotection in an in vivo model of retinal detachment, as well as blockage of PDGF, which may have potential antifibrotic benefits. DURAVYU has established a robust safety and efficacy profile with the largest TKI intravitreal (IVT) trial dataset in wet AMD to-date. Positive data from Phase 1 and Phase 2 (DAVIO 2) clinical trials of DURAVYU in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and CST and a favorable safety profile. Data from DAVIO 2 demonstrated an impressive treatment burden reduction of approximately 88% six months after treatment with DURAVYU, with over 80% of patients supplement-free or receiving only one supplemental anti-VEGF injection. DURAVYU is actively enrolling in two ongoing global Phase 3 clinical trials, LUGANO and LUCIA, in wet AMD. The pivotal programs are evaluating re-dosing of DURAVYU compared to non-inferiority with standard-of-care, with the goal of providing the retina community valuable insight into ‘real-world’ usage of DURAVYU. DURAVYU is also currently being studied for the treatment of diabetic macular edema (DME). The Phase 2 VERONA trial met the primary endpoint and demonstrated an immediate and sustained improvement in vision and anatomy, a continued favorable safety and tolerability profile with superior dosing intervals to standard of care. These positive Phase 2 results support the advancement of the DME program to a Phase 3 pivotal program which is anticipated to be initiated by the end of 2025. EyePoint (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™ 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™. Supported by robust safety and efficacy data to date, DURAVYU is presently in Phase 3 global, pivotal clinical trials for wet age-related macular degeneration (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 diabetic macular edema (DME). Based on positive Phase 2 results from the VERONA clinical trial in DME, EyePoint anticipates initiation of a Phase 3 pivotal program by the end of 2025 with 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 in multiple disease indications. 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. The content above comes from the network. if any infringement, please contact us to modify.

来源：新猎药人笔记 2025年2月6日，创新眼科产品开发商EyePoint Pharmaceuticals宣布，其进行中的VERONA临床2期试验的六个月结果积极，该试验评估了玻璃体植入疗法DURAVYU（vorolanib）用于治疗糖尿病性黄斑水肿（DME）患者的疗效与安全性。 图源：EyePoint官网 VERONA研究是一项随机、对照、单盲、开放标签的II期临床试验，旨在评估DURAVYU在已接受标准血管内皮生长因子（VEGF）靶向治疗的DME患者中的效果与安全性。试验共招募了27名患者，这些患者被分配接受1.34毫克或2.7毫克DURAVYU或获批VEGF抑制剂aflibercept的治疗。 试验成功达到主要终点，研究结果显示： • 延长首次补充治疗时间：与阿柏西普对照组相比，DURAVYU显著延长了首次补充治疗的时间。 • 视力改善：DURAVYU 2.7毫克组的患者在24周时BCVA提升+7.1个字母，而阿柏西普对照组的改善为3.2个字母。 • 视网膜厚度减少：DURAVYU 2.7毫克组的CST减少了75.9微米，而阿柏西普对照组为30.5微米。 • 治疗负担减轻：DURAVYU 2.7毫克组的治疗负担减少了三分之二以上，73%的患者未接受补充治疗，而阿柏西普对照组为50%。 • 安全性良好：迄今为止，没有与DURAVYU相关的眼部或全身严重不良事件。 EyePoint总裁兼首席执行官Jay S.Duker博士表示：“我们对VERONA试验取得的积极结果感到非常满意。试验表明，DURAVYU 2.7毫克可在糖尿病黄斑水肿（DME）患者中迅速且显著改善视力和解剖结构，并具有更优的给药间隔，这凸显了在严重视网膜疾病中DURAVYU作为‘同类最佳’治疗方案的潜力。” Wills Eye Hospital视网膜服务主任Carl Regillo博士强调了DURAVYU的零级动力学释放特性，确保VEGF受体至少六个月的持续阻断。这一特性将为DME患者和医生提供一种持久的治疗选择。 早在2022年，贝达药业便与EyePoint达成战略合作，获得DURAVYU在中国的独家开发与商业化权益。 结束语： EyePoint预计将在2025年年底启动关键的III期临床试验，并计划在2026年获得III期试验的顶线数据。DURAVYU的积极结果为其在DME治疗领域的应用提供了有力支持，有望为患者带来更优质的治疗方案。 免责声明： 文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。 联系我们 ISO 2025 展位火热预定中！ 扫码立即咨询 电话：13816031174 （同微信） 赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。 点击此处“阅读全文”咨询更多精彩！