ALPHARETTA, Ga., July 11, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today the appointment of Glenn C. Yiu, M.D., Ph.D., Professor of Ophthalmology at the University of California, Davis, to its Scientific Advisory Board (SAB), which is comprised of industry-leading retinal physicians who provide medical and scientific expertise and input on ...

ALPHARETTA, Ga., July 11, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today the appointment of Glenn C. Yiu, M.D., Ph.D., Professor of Ophthalmology at the University of California, Davis, to its Scientific Advisory Board (SAB), which is comprised of industry-leading retinal physicians who provide medical and scientific expertise and input on ...

- Webinar to be held on Wednesday, July 24, 2024 at 8:00 am ET - - Retina Specialists to Provide Insights and Real-World Experience with Suprachoroidal Drug Delivery - - Target Profile for CLS-AX in Wet AMD Landscape and Potential Opportunities for Clearside Pipeline Expansion - ALPHARETTA, Ga., June 27, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), annou ...

文章核心观点 - 公司正在利用其专利保护的专有的巩膜下腔(SCS®)注射技术平台,开发一系列针对视网膜疾病的新型治疗方法 [1][2][15] - 公司的SCS注射技术可以实现对眼后段的有针对性给药,提高药物在靶器官的生物利用度,同时减少对眼前段的毒性反应 [2][4][12] - 公司已获批首个用于巩膜下腔给药的产品XIPERE®,并正在开发CLS-AX用于治疗湿性年龄相关性黄斑变性,临床数据显示良好的安全性和疗效 [3][6][8][9] - 公司的SCS注射技术平台还与其他公司合作,开发针对糖尿病视网膜病变和葡萄膜黑色素瘤的新型治疗方法 [10][11] 关键要点总结 公司SCS注射技术平台 - 公司开发了专有的SCS Microinjector®,可以实现对眼后段的有针对性给药,提高药物在靶器官的生物利用度,同时减少对眼前段的毒性反应 [12] - 该技术可以与各种已上市和新型药物制剂配合使用,具有广泛的应用前景 [12] XIPERE®产品 - XIPERE®是公司首个获批的用于巩膜下腔给药的产品,用于治疗葡萄膜炎相关的黄斑水肿 [3] - 临床数据显示,单次XIPERE®注射后,75%以上的患者在6个月内无需再次给药,显示出良好的持久性 [3] CLS-AX产品 - CLS-AX是公司开发的一种用于巩膜下腔注射的axitinib悬浮液制剂,正在开展湿性AMD的II期临床试验 [6][13][14] - 临床前研究显示,CLS-AX具有良好的安全性和持久性,有望成为治疗湿性AMD的长效疗法 [8][14] - 与现有抗VEGF疗法相比,CLS-AX通过广谱VEGF受体阻断可能具有疗效优势 [14] 其他合作项目 - 公司的SCS注射技术平台还与REGENXBIO和Aura Biosciences合作,开发针对糖尿病视网膜病变和葡萄膜黑色素瘤的新型治疗方法 [10][11]

- Broad Use of Suprachoroidal Injection Platform Highlighted Across Retinal Indications - - Robust Safety Profile and Encouraging Efficacy Data Reported Utilizing SCS Microinjector® - ALPHARETTA, Ga., June 12, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that multiple oral presentations were delivered at the Clinical Trials at the Summit ...

- Expert Panel of Ophthalmologists Developed Professional Guidelines in Using the Innovative Technique for Retinal Therapeutic Delivery - - Current Clinical Evidence and Physician Experience Support SCS Injection as a Safe and Effective Method for Delivering Retinal and Choroidal Therapeutics - ALPHARETTA, Ga., May 21, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal spa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ 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 Commission File Number: 001-37783 Clearside Biomedical, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 45-2437375 (State or other jurisdiction of (I.R.S. Employer incorp ...

财务数据和关键指标变化 - 公司现金及现金等价物总额约为3500万美元,预计可为公司运营提供资金支持至2025年第三季度 [16] 各条业务线数据和关键指标变化 - 公司的SCS Microinjector技术已在临床上进行了数千次注射,并继续展现出良好的安全记录,迄今未出现任何内眼炎病例 [9] 各个市场数据和关键指标变化 - 湿性AMD市场每年销售额超过120亿美元,现有获批疗法如faricimab和高剂量aflibercept虽然有效,但只能维持4个月左右的疗效,公司认为CLS-AX可能将大多数患者的给药间隔延长至6个月,从而大幅降低患者、照顾者和支付方的用药负担 [13] 公司战略和发展方向及行业竞争 - 公司正在内部规划CLS-AX的III期临床试验设计,正在与顾问讨论多种选择,并将与监管机构进行沟通以确定最佳方案 [35][36][41] - 公司认为CLS-AX相比其他在研的酪氨酸激酶抑制剂(TKI)具有优势,因为CLS-AX的抗VEGF IC50值明显更低,即更加强效 [26] - 公司正在关注如何最大化CLS-AX的优势,同时也要考虑未来眼科医生更容易使用该药物 [36] 管理层对经营环境和未来前景的评论 - 公司认为2024年将是转型的一年,将继续保持在眼底给药途径的领导地位,并与合作伙伴共同产生更多临床数据,展现给药途径的潜在优势 [18] - 公司相信ODYSSEY试验的数据结果将证明CLS-AX可能成为治疗湿性AMD这一数十亿美元市场的有价值补充 [18] 问答环节重要的提问和回答 问题1 **Jon Wolleben 提问** 询问ODYSSEY试验纳入标准中"活跃疾病"的定义,以及与其他中期湿性AMD试验的差异 [22] **Victor Chong 回答** ODYSSEY试验要求患者仍存在视网膜下液或视网膜内液,或荧光血管造影显示渗漏,即仍有活跃疾病,这与一些已经稳定的患者不同 [24] 问题2 **Jon Wolleben 提问** 询问CLS-AX与其他在研TKI的比较,以及公司认为ODYSSEY试验结果中哪些指标最为重要 [25] **Victor Chong 回答** CLS-AX的抗VEGF IC50值明显低于其他TKI,即更加强效;公司正在等待II期试验数据,这将有助于设计III期试验,关键指标仍以视力改善为最重要 [26][28] 问题3 **Unidentified Analyst 提问** 询问公司是否已考虑III期试验设计,尤其是在竞争对手正在进行优效性对照试验的背景下 [34] **George Lasezkay 和 Victor Chong 回答** 公司正在内部讨论III期试验设计,并将与监管机构进行沟通,希望利用CLS-AX可重复给药的优势来设计更有竞争力的方案 [35][36]

Clearside Biomedical, Inc. (CLSD) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -21.43%. A quarter ago, it was expected that this company would post a loss of $0.10 per share when it actually produced a loss of $0.08, delivering a surprise of 20%. Over the last four quarters, the company h ...

Exhibit 99.1 Clearside Biomedical Announces First Quarter 2024 Financial Results and Provides Corporate Update - Phase 2b ODYSSEY Trial in Wet AMD Remains on Track with Topline Data Expected Q3 2024 - - Strengthened Management Team and Board of Directors with Two Key Additions - - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET - ALPHARETTA, Ga., May 9, 2024 -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of ...