UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 08, 2024 EyePoint Pharmaceuticals, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 000-51122 26-2774444 (State or Other Jurisdiction (Commission File Number) (IRS Employer of Incorporation) Identification No .) 480 Pleasant Street Watertown, Massachusetts 02472 (Address ...

– Phase 3 trial design for the LUGANO and LUCIA pivotal non-inferiority trials of DURAVYU in wet AMD based on positive EOP2 meeting with FDA; on track for trial initiation in 2H 2024 – – Positive twelve-month safety and efficacy data from Phase 2 DAVIO 2 clinical trial evaluating DURAVYU for the treatment of wet AMD reinforces potential as a sustained six-month maintenance therapy – – Phase 2 trial of DURAVYU in diabetic macular edema (DME) fully enrolled – – EyePoint to webcast its R&D Day event today at 8 ...

An overview of the science behind DURAVYU™ (vorolanib intravitreal insert), formerly known as EYP1901, an investigational sustained-release therapy with the potential to alter the treatment paradigm for patients suffering from VEGF-mediated retinal diseases A review of the positive Phase 2 DAVIO 2 trial results in wet AMD, including 12-month topline data An update on the pivotal non-inferiority Phase 3 trial plans for DURAVYU™ in wet AMD A KOL roundtable discussion with Drs. Regillo and Modi moderated by Ey ...

An overview of the science behind DURAVYU™ (vorolanib intravitreal insert), formerly known as EYP1901, an investigational sustained-release therapy with the potential to alter the treatment paradigm for patients suffering from VEGF-mediated retinal diseases A review of the positive Phase 2 DAVIO 2 trial results in wet AMD, including 12-month topline data An update on the pivotal non-inferiority Phase 3 trial plans for DURAVYU™ in wet AMD A KOL roundtable discussion with Drs. Regillo and Modi moderated by Ey ...

WATERTOWN, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases, today announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company's 2023 Long-Term Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4). The Company granted stock options to purchase up to an aggregate of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ COMMISSION FILE NUMBER 000-51122 EyePoint Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2774444 (State or o ...

关于DURAVYU在NPDR临床试验结果 - DURAVYU在非增殖性糖尿病视网膜病变（NPDR）患者中有生物效应且安全性和耐受性良好但未达到预定主要终点[1] - 3mg组86%、2mg组80%的患者在九个月时病情稳定或改善对照组为70% 2mg组5%、3mg组0%的患者在九个月时恶化≥2步对照组为10% 3mg组5%、2mg组0%的患者在九个月时DRSS评分改善≥2步对照组为5%[2][3] - 未出现DURAVYU相关眼部或全身严重不良事件未观察到眼内炎或视网膜血管炎病例[4] 关于PAVIA临床试验 - PAVIA是一项针对中重度NPDR患者为期12个月的随机对照2期临床试验共招募77名患者随机分配到DURAVYU的两个剂量组或对照组主要终点是注射DURAVYU后约九个月DRSS水平至少改善两级更多信息可在clinicaltrials.gov查询[5] 关于公司后续计划 - 公司将在审查完12个月的完整数据后提供DURAVYU作为NPDR潜在治疗方法的后续计划[1] - 公司仍按计划推进DURAVYU的临床里程碑包括2024年下半年启动湿性年龄相关性黄斑变性（wet AMD）的3期关键试验LUGANO以及后续试验2025年第一季度预计得到糖尿病性黄斑水肿（DME）的2期VERONA试验的主要数据[6] 关于DURAVYU产品 - DURAVYU已被FDA有条件接受为EYP - 1901的专有名称但尚未被FDA批准批准时间不确定[7] - DURAVYU正在开发用于治疗VEGF介导的视网膜疾病采用EyePoint的专有持续释放Durasert E™技术[10] - DURAVYU目前正在湿性年龄相关性黄斑变性（wet AMD）、非增殖性糖尿病视网膜病变（NPDR）和糖尿病性黄斑水肿（DME）的三项2期临床试验中进行评估[11] 关于公司情况 - EyePoint制药公司致力于开发和商业化治疗严重视网膜疾病的疗法[14] - 公司的产品线利用其专有的生物可蚀性Durasert E™技术进行眼内持续给药[15]

财务数据和关键指标变化 - 2023年第四季度总收入为1400万美元,同比增长33% [31][36] - 2023年全年总收入为4600万美元,同比增长11% [36][37] - 2023年第四季度产品净收入为70万美元,同比下降93%,主要由于公司在2023年上半年退出商业业务 [32][33] - 2023年全年产品净收入为1420万美元,同比下降64% [36] - 2023年第四季度来自特许权使用费和合作的净收入为1330万美元,同比大幅增长 [33] - 2023年全年来自特许权使用费和合作的净收入为3180万美元,同比大幅增长 [37] - 2023年第四季度经营费用为3040万美元,同比下降44%,主要由于退出商业业务和2022年第四季度的一次性无形资产减值 [34] - 2023年全年经营费用为12110万美元,同比下降14% [37] - 2023年12月31日现金及投资总额为3.311亿美元,较2022年12月31日的1.446亿美元大幅增加 [39] 各条业务线数据和关键指标变化 - 公司已于2023年上半年退出商业业务,将YUTIQ产品线进行了授权 [32][33] - 公司正专注于EYP-1901的临床开发,这是公司的主要管线产品 [9][10][11][12][13] 各个市场数据和关键指标变化 - 未提及具体市场数据和关键指标变化 公司战略和发展方向及行业竞争 - 公司已完成向临床阶段生物制药公司的转型,并成功退出商业业务 [9] - 公司正专注于EYP-1901在湿性AMD、NPDR和DME三个适应症的临床开发 [10][18][22] - 公司认为EYP-1901有潜力改变VEGF相关视网膜疾病的现有治疗范式 [24] - 公司正在评估其他分子在Durasert E给药系统中的应用,包括补体抑制和罕见疾病 [25][26] - 公司认为基因疗法在湿性AMD治疗中面临一些挑战,需要在疗效和安全性之间精确平衡 [83][84] 管理层对经营环境和未来前景的评论 - 管理层对2023年取得的进展和2024年的发展计划表示乐观 [41][42] - 管理层认为公司有望执行好即将到来的里程碑,并继续推动创新长期解决方案,改善患有严重视网膜疾病患者的视力和生活质量 [42] 问答环节重要的提问和回答 问题1 **Tessa Romero 提问** 公司如何进一步细分NPDR患者群体,哪些患者是公司的主要目标群体 [44] **Ramiro Ribeiro 回答** 公司认为眼部NPDR最严重的患者是首要治疗对象,因为这些患者更容易发展成威胁视力的并发症,如DME和增殖性糖尿病视网膜病变。通过EYP-1901大约每9个月给药一次,可以显著延缓这些并发症的发展,从而改善患者的生活质量 [49][50] 问题2 **Tyler Van Buren 提问** 公司与FDA的end-of-phase 2会议将讨论哪些关键议题,之前公司与FDA的互动情况如何 [52] **Jay Duker 回答** 公司之前与FDA有多次讨论,就湿性AMD III期临床试验的设计达成了共识。公司计划在end-of-phase 2会议上确认一些细节,如入排标准和安全性队列等,但不太可能有什么关键性议题 [53][54][55] 问题3 **Yatin Suneja 提问** NPDR试验设定30%-35%的改善率作为进入下一阶段的标准,与现有VEGF抑制剂45%-50%的改善率相比,公司为何选择这个较低的标准 [58] **Jay Duker 回答** 这个标准是基于临床医生的反馈,即使有1/3的患者有一个级别的改善,只要EYP-1901安全有效且给药频率低,他们也会在相当多的NPDR患者中使用。现有VEGF抑制剂改善率高,但由于给药频繁,临床医生和患者参与度较低 [60][61][62]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 000-51122 EyePoint Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2774444 (State or other jurisdiction of (I ...

EyePoint Pharmaceuticals (EYPT) reported $14.03 million in revenue for the quarter ended December 2023, representing a year-over-year increase of 33.2%. EPS of -$0.33 for the same period compares to -$0.61 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $8.71 million, representing a surprise of +61.00%. The company delivered an EPS surprise of +45.00%, with the consensus EPS estimate being -$0.60.While investors scrutinize revenue and earnings changes year-over-year and how they ...