Axitinib

编者按：美国临床肿瘤学会（ASCO）年会将在芝加哥以线上线下结合的形式盛大召开（5月30日~6月3日）。作为全球规模最大、学术水平最高、最具权威性的国际肿瘤会议之一，2025年ASCO年会汇聚了肿瘤领域前沿进展，带领临床医生及科研学者走向灵感澎湃、进展迭出的新世界。今天，2025 ASCO摘要标题（包括Late-Breaking Abstracts）已发布。摘要具体内容将在2025年5月22日发布，Late-breaking摘要内容将在会议当天发布。肿瘤瞭望-泌尿时讯特别整理泌尿肿瘤领域中国专家入选口头报告及壁报，包括1篇口头报告+21篇壁报。01肾癌及膀胱癌快速口头报告专场当地时间：5月31日13:15-14:33报告地点：Arie Crown Theater摘要号：4519英文标题：9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (la/mUC)： Results from a phase 1b/2 study.中文标题：9MW2821是一种新型Nectin-4抗体偶联药物，与特瑞普利单抗联合用于治疗初治局部晚期或转移性尿路上皮癌患者：1b/2期研究结果讲者：盛锡楠教授 北京大学肿瘤医院02肾癌及膀胱癌壁报专场当地时间：6月2日09：00报告地点：Hall A - Posters and Exhibits摘要号：4524英文标题：Comparison of 68Ga-NY104 PET/CT with 18F-FDG PET/CT in patients with metastatic clear cell renal cell carcinoma (NYCRM)： A prospective, comparative phase II study.中文标题：转移性透明细胞肾细胞癌（NYCRM）患者使用68Ga-NY104 PET/CT与18F-FDG PET/CT的比较：一项前瞻性、比较性II期研究讲者：朱文佳教授  中国医学科学院北京协和医学院肿瘤医院摘要号：4525英文标题：Anlotinib plus everolimus as first-line treatment for advanced non–clear cell renal cell carcinoma： 1 year updated results from UC-001, a single-center, single-arm, phase II trial.中文标题：安罗替尼联合依维莫司作为晚期非透明细胞肾细胞癌的一线治疗：单中心、单组、II期试验UC-001的1年更新结果讲者：徐文浩教授 复旦大学附属肿瘤医院摘要号：4526英文标题：Anlotinib combined with sintilimab as first-line treatment in patients with advanced non-clear cell renal cell carcinoma (nccRCC)： Preliminary results from an exploratory prospective multicentre clinical study.中文标题：安罗替尼联合信迪利单抗一线治疗晚期非透明细胞肾细胞癌（nccRCC）患者：一项探索性前瞻性多中心临床研究的初步结果讲者：董培教授 中山大学肿瘤防治中心摘要号：4534英文标题：Early detection of renal cell carcinoma： A novel cfDNA fragmentomics-based liquid biopsy assay.中文标题：肾细胞癌的早期检测：一种基于cfDNA片段组学的新型液体活检检测方法讲者：彭毓璐教授 中山大学肿瘤防治中心摘要号：4535英文标题：Efficacy and safety of neoadjuvant toripalimab plus axitinib in renal cell carcinoma with tumor thrombus： A combined analysis of two phase II trials.中文标题：特瑞普利单抗联合阿昔替尼新辅助方案治疗肾细胞癌伴癌栓的疗效和安全性：两项II期临床试验的综合分析讲者：顾良友教授 中国人民解放军总医院摘要号：4536英文标题：First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma： Subgroup analysis from the phase 3 ETER100 trial.中文标题：贝莫苏拜单抗联合安罗替尼对比舒尼替尼一线治疗晚期肾细胞癌的疗效：来自III期ETER100试验的亚组分析讲者：盛锡楠教授 北京大学肿瘤医院摘要号：4551英文标题：Vasculogenic mimicry as a potential indicator of drug resistance and prognosis in renal cell carcinoma.中文标题：血管生成拟态是肾细胞癌耐药性和预后的潜在指标讲者：崔心刚教授 上海交通大学医学院附属新华医院摘要号：4584英文标题：Revolutionizing bladder cancer follow-up： Personalized urinary ctDNA analysis for detecting minimal residual disease.中文标题：革命性的膀胱癌随访：个性化尿液ctDNA分析用于检测微小残留疾病讲者：万学斌博士 深圳市海普洛斯生物科技有限公司摘要号：4585英文标题：An exploratory study of clostridium butyricum combined with neoadjuvant chemoimmunotherapy in urothelial carcinoma.中文标题：丁酸梭菌联合新辅助化学免疫治疗治疗尿路上皮癌的探索性研究讲者：杨潇教授 南京医科大学第一附属医院（江苏省人民医院）摘要号：4586英文标题：Updated efficacy and safety results from ReBirth, a phase II study of risk-based bladder-sparing therapy for MIBC.中文标题：ReBirth临床研究的最新疗效和安全性结果，ReBirth是一项针对MIBC的基于风险的膀胱保留治疗的II期研究讲者：沈益君教授 复旦大学附属肿瘤医院摘要号：4587英文标题：Postoperative assessment using urinary tumor DNA (utDNA) to identify potential candidates for repeat transurethral resection of bladder tumor (re-TURBT) in non-muscle invasive bladder cancer (NMIBC)： A retrospective analysis.中文标题：术后使用尿液肿瘤DNA（utDNA）评估以确定非肌层浸润性膀胱癌（NMIBC）再次经尿道膀胱肿瘤切除术（re-TURBT）的潜在获益患者：一项回顾性分析讲者：Zihan Xue 天津医科大学第二医院摘要号：4588英文标题：Updated results from a phase II study of perioperative disitamab vedotin (RC48-ADC) plus cadonilimab (AK104) for HER2-expressing muscle-invasive bladder cancer (MIBC).中文标题：围手术期维迪西妥单抗（RC48-ADC）联合卡度尼利单抗（AK104）治疗HER2表达的肌层浸润性膀胱癌的II期研究最新结果讲者：韩苏军教授 国家癌症中心/中国医学科学院肿瘤医院，中国医学科学院北京协和医学院肿瘤医院摘要号：4590英文标题：Efficacy and safety of disitamab vedotin (RC48) combined with toripalimab as adjuvant therapy after radical surgery for patients with HER2-overexpression upper tract urothelial cancer (UTUC)： A single-arm, prospective, phase 2 clinical trial.中文标题：维迪西妥单抗（RC48）联合特瑞普利单抗作为HER2过表达上尿路尿路上皮癌（UTUC）患者根治术后辅助治疗的疗效和安全性：一项单臂、前瞻性、2期临床试验讲者：Shouyong Liu 南京大学医学院附属金陵医院摘要号：4592英文标题：Prognostic impact of histological subtypes in non-muscle-invasive UTUC： Propensity matched analysis.中文标题：组织学亚型对非肌层侵袭性UTUC预后的影响：倾向匹配分析讲者：Yunkai Qie 天津医科大学第二医院摘要号：4606英文标题：IL-15RαFc superagonist SHR-1501 with or without bacille Calmette Guerin (BCG) for high-risk non-muscle invasive bladder cancer (NMIBC)： A phase 1/2 study.中文标题：IL-15RαFc超激动剂SHR-1501联合或不联合卡介苗治疗高危非肌层浸润性膀胱癌（NMIBC）：一项1/2期研究讲者：Yuke Chen 北京大学第一医院摘要号：4607英文标题：Results of BH011 after intravesical administration in patients with CIS and/or papillary non-muscle invasive bladder cancer (NMIBC) after BCG failure： Interim results from a phase I/II clinical trial.中文标题：BH011在BCG失败后的CIS和/或乳头状非肌层浸润性膀胱癌患者中膀胱内给药后的结果：I/II期临床试验的中期结果讲者：叶定伟教授 复旦大学附属肿瘤医院摘要号：TPS4617英文标题：Clinical effectiveness of urine DNA for minimal residual disease (MRD) monitoring of urothelial carcinoma in urine： A multicenter, prospective, observational study.中文标题：尿液DNA对尿路上皮癌微小残留病灶（MRD）监测的临床效果：一项多中心、前瞻性、观察性研究讲者：郭璇骏教授 北京大学第一医院摘要号：TPS4624英文标题：PUNCH03： A phase II study of disitamab vedotin combined with tislelizumab and bacillus Calmette-Guerin (BCG) in Her2-positive high-risk non-muscle-invasive bladder cancer (HR NMIBC).中文标题：PUNCH03：维迪西妥单抗联合替雷利珠单抗和卡介苗治疗HER2阳性高危非肌层浸润性膀胱癌（HR NMIBC）的II期研究讲者：王宗任教授 中山大学附属第一医院03前列腺癌、睾丸癌及阴茎癌壁报专场当地时间：6月2日09：00报告地点：Hall A - Posters and Exhibits摘要号：5038英文标题：Spatial transcriptional dynamics of CD74⁺ B cells in tertiary lymphoid structures and effects on immune evolution in penile squamous cell carcinoma.中文标题：CD74⁺ B细胞在三级淋巴结构中的空间转录动态及其对阴茎鳞状细胞癌免疫进化的影响讲者：Zaishang Li 深圳市人民医院摘要号：5047英文标题：Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as an initial treatment in unselected patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in the China cohort of the phase 3 TALAPRO-2 trial.中文标题：在3期TALAPRO-2试验的中国队列中，未经选择的转移性去势抵抗性前列腺癌患者使用他拉唑帕利+恩扎卢胺作为初始治疗的最终总生存期讲者：卞晓洁教授 复旦大学附属肿瘤医院摘要号：5075英文标题：Exploring PSMA heterogeneity and alternative targets expression in PSMA-negative prostate cancer.中文标题：探索PSMA阴性前列腺癌中的PSMA异质性和替代靶标表达讲者：Yelin Mulati 北京大学第一医院（来源：《肿瘤瞭望-泌尿时讯》编辑部）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

AXPAXLI™ SOL trials for wet AMD progressing rapidly following recent updates to accelerate and enhance the registrational program Following positive FDA feedback for potential AXPAXLI NPDR registrational trial, Ocular is actively planning next steps in NPDR and DME SOL-1 retention remains exceptional as trial is on track for 1Q 2026 topline data readout SOL-R continues to have strong enrollment through streamlined, accelerated execution Cash balance of $349.7M as of March 31, 2025, with expected runway through topline data for SOL-1 and SOL-R and into 2028 BEDFORD, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the first quarter ended March 31, 2025, and provided recent business highlights. “We continue to advance the SOL registrational program for our product candidate AXPAXLI in wet AMD with urgency and precision. Our unwavering focus is on redefining the retina experience. Delivering a more sustainable therapy designed to drive better long-term outcomes is central to this effort. Earlier this year, we implemented strategic regulatory updates designed to accelerate the SOL program, enhancing capital and operational efficiencies. We believe these refinements could position AXPAXLI for an unprecedented 6 to 12-month dosing regimen on the label for the treatment of wet AMD and potentially enable an earlier NDA submission. These enhancements were made in alignment with FDA feedback and preserve the scientific integrity and robust powering of our two complementary registrational studies, SOL-1 and SOL-R,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “In addition to our momentum in wet AMD, we are thrilled with the positive written feedback received from the FDA on the design of a potential registrational trial for AXPAXLI in NPDR. These encouraging interactions represent a meaningful step forward as we plan our next steps in both NPDR and DME.” “Backed by a world-class team, strong capital position, and disciplined execution, we believe we are in an outstanding position as we pursue our goal of becoming a leading retina company,” concluded Dr. Dugel. Recent Achievements and Upcoming Milestones: SOL-1 (Phase 3, wet AMD) retention remains exceptional and the vast majority of rescues, evaluated on a masked basis, continue to be per protocol. Topline data are on track for 1Q 2026. In March, the Company announced that the FDA accepted an amendment to the SOL-1 Special Protocol Assessment (SPA) agreement that includes re-dosing of all subjects at Weeks 52 and 76 with their respective initial treatment of AXPAXLI or aflibercept (2 mg). Subjects will remain masked and are then followed for safety until the end of year two. This optimized design enhances the potential to achieve label flexibility for dosing AXPAXLI every 6 to 12 months and should provide valuable insights into AXPAXLI’s long-term durability. SOL-R (Phase 3, wet AMD) enrollment continues to be strong following the recent reduction in target randomization to approximately 555 subjects (previously 825). The strong SOL-1 subject retention observed to date and re-dosing amendment have enabled Ocular to reduce the size of the SOL-R non-inferiority study while continuing to meet the FDA requirements for long-term safety data. Streamlining the execution of SOL-R is expected to accelerate the trial readout and, if successful, the AXPAXLI wet AMD NDA submission timeline. SOL-R remains robustly powered at 90% with the non-inferiority margin of -4.5 ETDRS letter per FDA guidance. Written feedback received from FDA on AXPAXLI registrational trial in non-proliferative diabetic retinopathy (NPDR). The FDA provided positive feedback to Ocular on a potential registrational trial design for AXPAXLI in NPDR. Following recent changes more broadly within the FDA, Ocular has not noticed any disruption in the cadence and nature of its dialogue with the Agency to date and continues to maintain productive interactions. The Company is actively planning next steps in the development of AXPAXLI for NPDR and diabetic macular edema (DME) and expects to provide further details at a later date. First Quarter Ended March 31, 2025, Financial Results: Total cash and cash equivalents were $349.7 million as of March 31, 2025. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA®, the Company believes that its current cash balance is sufficient to support its planned expenses, debt service obligations, and capital expenditure requirements into 2028. This cash projection does not factor in the impact of potential clinical trial activities for AXPAXLI in NPDR and DME. Total net revenue was $10.7 million for the first quarter of 2025, a 27.6% decrease as compared to total net revenue of $14.8 million in the comparable quarter in 2024. This decrease was driven by decreased gross revenues from DEXTENZA sales. Total net revenue includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which the Company refers to as net product revenue, and collaboration revenue. The Company’s net product revenue was $10.6 million for the three months ended March 31, 2025, reflecting a decrease of $4.1 million or 27.7% over the comparable quarter in 2024. The Company believes the decline in first quarter 2025 DEXTENZA net sales is primarily attributable to the impact of its pricing strategy on distributor stocking patterns and buying patterns by ambulatory surgical centers (ASCs), hospital outpatient departments (HOPDs), and physicians’ offices, as well as the recent inclusion of DEXTENZA into the cost performance category of the Centers for Medicare & Medicaid Services’ Merit-based Incentive Payment System (MIPS) for 2025. The Company anticipates that net product revenue on a quarterly basis should increase for the remainder of 2025, driven primarily by expected increases in the number of units sold, as clinicians adjust to the impact of MIPS, and as the Company increases sales efforts directed towards HOPDs, which are receiving separate payment for DEXTENZA in 2025 after being ineligible for separate payments in 2024. Research and development expenses for the first quarter of 2025 were $42.9 million versus $20.7 million for the comparable quarter in 2024, reflecting an increase in overall clinical expenses associated with the SOL-1 and SOL-R Phase 3 clinical trials, as well as additional personnel and professional services to support these clinical trials. Selling and marketing expenses were $14.1 million for the first quarter of 2025, as compared to $10.2 million for the comparable quarter of 2024, primarily reflecting an increase in personnel-related costs, including stock-based compensation expense, and professional fees associated with pre-commercialization activities for AXPAXLI. General and administrative expenses were $16.3 million for the first quarter of 2025, as compared to $14.1 million for the comparable quarter of 2024, primarily due to an increase in personnel-related costs, including stock-based compensation expense. Net loss for the first quarter of 2025 was $(64.1) million, or a net loss of $(0.38) per share on both a basic and diluted basis, compared to a net loss of $(64.8) million, or a net loss of $(0.49) per share on a basic and diluted basis, for the comparable quarter of 2024. The net loss in the first quarter of 2025 includes a net loss from the change in fair value of our derivative liability of $(1.0) million, which is comprised of a non-cash loss from fair value measurement of the derivative liability associated with the Barings Credit Facility of $(0.6) million, and expense related to actual royalty fees under the Barings Credit Facility of $(0.4) million, compared to a $(5.2) million net loss for the first quarter of 2024, which is comprised of a net non-cash loss attributable to fair value measurements of the derivative liabilities associated with the Barings Credit Facility and the Company's convertible notes of $(4.6) million, and expense related to actual royalty fees under the Barings Credit Facility of $(0.5) million. Outstanding shares as of May 1, 2025, were approximately 159.3 million. About AXPAXLIAXPAXLI™ (also known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD, diabetic retinopathy, diabetic macular edema, and other retinal diseases. About the SOL-1 StudyThe registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel group study that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December 2024, the trial completed randomization of 344 evaluable treatment-naïve subjects with a diagnosis of wet AMD in the study eye. The superiority study has an eight-week loading segment prior to randomization. During the loading segment, subjects who have 20/80 vision or better and who satisfy other enrollment criteria receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Eligible subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 or gain at least 10 early treatment diabetic retinopathy study (ETDRS) letters at Day 1 are then randomized to receive a single dose of AXPAXLI or a single dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI or aflibercept (2 mg). Subjects will be followed for safety until the end of Year 2. Throughout the study, subjects are assessed monthly. Trial subjects and designated study personnel will remain masked through the end of Year 2. The clinical trial protocol requires that, during the study, subjects in either arm meeting pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, defined as a loss of <15 ETDRS letters of BCVA, at Week 36. Subjects will continue to be evaluated for durability up to Week 52. The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. About the SOL-R StudyThe registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm study that will involve sites located in the U.S. and the rest of the world. The trial is intended to randomize approximately 555 subjects who are treatment-naïve or were diagnosed with wet AMD in the study eye within about four months prior to enrollment. This non-inferiority trial reflects a patient enrichment strategy over the six months prior to randomization that includes three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitoring to exclude those subjects with significant retinal fluid fluctuations. Subjects that continue to meet eligibility will enter a run-in period and receive two loading doses of aflibercept (2 mg) prior to Day 1. Subjects in the first arm receive a single dose of AXPAXLI at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects in the second arm receive aflibercept (2 mg) on-label every eight weeks. Subjects in the third arm receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate masking. Subjects will be followed for safety until the end of Year 2. Throughout the study, subjects are assessed monthly. Trial subjects and designated study personnel will remain masked through the end of Year 2. Subjects in any arm that meet pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg). The pre-specified rescue criteria include loss of ≥ 10 letters of BCVA from baseline or a combination of worsening anatomical measures and BCVA loss. The primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at Week 56. As per the protocol agreed to by the FDA, the non-inferiority margin for the lower bound is -4.5 letters of mean BCVA when compared to aflibercept (2 mg) dosed every eight weeks. In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD study, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled study in support of a potential New Drug Application and product label for wet AMD. About Wet AMDWet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14.5 million individuals globally and 1.7 million in the United States alone (2024 Market Scope® Retinal Pharmaceuticals Market Report). Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events and up to 40% patient discontinuation within one year of initiating treatment with continued disease progression. Taken together, these factors lead to undertreatment and a lack of long-term vision improvement for patients. About Ocular Therapeutix, Inc.Ocular Therapeutix, Inc. is a fully-integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate PAXTRAVA™ (also known as OTX-TIC), which is a travoprost intracameral hydrogel that is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Follow the Company on its website, LinkedIn, or X. The Ocular Therapeutix logo and DEXTENZA® are registered trademarks of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Forward-Looking StatementsAny statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA; the development, regulatory status of and regulatory submissions regarding the Company’s product candidates; the design of, and the timing of the screening, enrollment and randomization of patients in and the availability of data from the Company’s SOL-1 and SOL-R Phase 3 clinical trials of AXPAXLI (also known as OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI, including in additional indications such as NPDR and DME, and its other product candidates; the potential utility or adoption, if approved, of any of the Company’s product candidates; the Company’s cash runway and the sufficiency of the Company’s cash resources; and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “designed”, “goal”, “may”, “might”, “plan”, “predict”, “project”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue”, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of any product or product candidate that receives regulatory approval; the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA; the initiation, design, timing, conduct and outcomes of ongoing and planned clinical trials; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under the Special Protocol Assessment for the SOL-1 trial; the risk that the FDA may not agree that the protocol and statistical analysis plan of SOL-R or that the data generated by the SOL-1 and SOL-R trials support marketing approval, even if the trials are successful; the risk that the Company and the FDA may not agree on the registrational pathway for any of its product candidates; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials, whether preliminary or interim data from a clinical trial (including masked safety or masked rescue data from the Company’s SOL-1 trial) will be predictive of final data from such trial, or whether data from a clinical trial assessing a product candidate for one indication will be predictive of results in other indications; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Investors & MediaOcular Therapeutix, Inc.Bill SlatteryVice President, Investor Relationsbslattery@ocutx.com