Aceclidine

VIZZ sample distribution initiated nationwide to Eye Care Professionals Commercial product shipments to be initiated in October to consumers with broad product availability by mid-Q4 2025 VIZZ is the first and only aceclidine-based eye drop approved to improve near vision in adults with presbyopia for up to 10 hours, a condition impacting approximately 128 million adults in the United States SAN DIEGO, Calif., Sept. 30, 2025 /PRNewswire/ -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or "LENZ" or the "Company"), today announced VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults, is now available. Professional product sample distribution by the sales force to optometrists and ophthalmologists has been initiated nationwide. Commercial product shipments will be initiated to consumers in October through our ePharmacy partner and is anticipated to be broadly available, including via retail pharmacies, by mid-Q4 2025. Continue Reading Box Front with Ampoule Age-related vision loss (presbyopia) background infographic Experience the full interactive Multichannel News Release here: "We are thrilled to introduce VIZZ to the 128 million adults living with blurry near vision in the United States," said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. "The team has been preparing for this moment for months and worked tirelessly to enable the availability of product samples and commercial product following our FDA approval. Initial feedback and early brand awareness from the ECP community is extremely positive, and we feel well-positioned for a successful product launch, firmly establishing VIZZ as a Category of One for the treatment of presbyopia." VIZZ is powered by aceclidine, differentiated by its mechanism of action as a predominantly pupil-selective miotic that interacts with the iris, with minimal ciliary muscle stimulation. VIZZ contracts the iris sphincter muscle, resulting in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift. In the CLARITY Phase 3 clinical trial, 93% of participants achieved 20/40 or better near vision within 30 minutes and lasted up to 10 hours. This level of near vision can restore the ability to read a phone screen and other everyday fine print without the assistance of reading glasses. "With VIZZ now available, we're giving people living with presbyopia a simple, fast-acting way to see up close again," said Shawn Olsson, Chief Commercial Officer of LENZ Therapeutics. "It's about restoring everyday confidence, including reading a phone, checking a price tag, or enjoying your active lifestyle glasses-free. We're excited to bring this new option to millions who want more freedom in their near vision." For more information about VIZZ and full prescribing information, please visit About Presbyopia Presbyopia is the inevitable loss of near vision associated with aging. It impacts the daily lives of nearly all people over the age of 45. As people age, the crystalline lens in their eyes gradually hardens and becomes less able to change shape. This loss of elasticity of the lens reduces the ability of the lens to focus incoming light from near objects onto the retina. Adults over age 50 lose, on average, 1.5 lines of near vision every six years. Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s, when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. Presbyopia is typically self-diagnosed and self-managed with over-the-counter reading glasses, or managed, after evaluation by an ECP, with prescription reading or bifocal glasses or multifocal contact lenses. About VIZZ (aceclidine ophthalmic solution) 1.44% VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours. Aceclidine is the sole active ingredient in VIZZ and provides rapid and durable near vision improvement. VIZZ is preservative-free and provided in single-dose vials. VIZZ is a predominantly pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation. VIZZ causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision. VIZZ Indication and Important Safety Information INDICATION VIZZ (aceclidine ophthalmic solution) 1.44% is a prescription eye drop used to treat age-related blurry near vision (presbyopia) in adults. IMPORTANT SAFETY INFORMATION Do not use VIZZ if allergic to any of the ingredients. To help avoid potential eye injury or contamination of the product, do not allow the vial tip to touch the eye or any surfaces. Discard the opened vial immediately after use. Contact lenses should be removed before using VIZZ. After dosing, contact lenses can be reinserted after 10 minutes. If using more than one topical eye medication, the medicines should be administered at least 5 minutes apart. Temporary dim or dark vision may be experienced after using VIZZ. Do not drive or operate machinery if vision is not clear. Seek immediate medical care if sudden onset of flashing lights, floaters, or vision loss is experienced. ADVERSE REACTIONS The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in >5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving. For additional information, please see the full Prescribing Information available at About LENZ Therapeutics LENZ Therapeutics is a pharmaceutical company focused on the commercialization of VIZZ™ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. LENZ is commercializing VIZZ in the United States and continues to establish licensing partnerships internationally to provide access to VIZZ globally. LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws. You can identify forward-looking statements by words such as "may," "will," "could," "can," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "poised," "continue," "ongoing" or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. " Forward-looking statements in this press release include statements regarding the timing and availability of VIZZ; potential market size for VIZZ; its ability to meet patient needs and become standard of care; LENZ commercialization plans, including international partnering plans, and the quotations of LENZ management. These statements are based on numerous assumptions concerning VIZZ, target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled "Risk Factors" in our Quarterly Report on Form 10-Q filed for the quarter ended June 30, 2025 and our subsequent filings with the SEC. We cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Contact: Dan Chevallard LENZ Therapeutics [email protected] SOURCE LENZ Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

今年九月，国内新药申报上市迎来了大爆发。 根据 Insight 数据库，截至 9 月 29 日，共计有 31 款新药在本月向 NMPA 递交了上市申请（含新适应症，不含原研地产化品种），数量为今年单月第 2 高。其中，国产药有 14 款，进口药有 17 款。药物类型上，化药有 14 款，生物药有 17 款。 从国内注册信息来看，31 款药中，有 17 个新药是首次申报上市，其中包括 11 款 1 类新药。本文将对其中几款首次报产的新药信息做介绍。 恒瑞医药：HRS9531 首个国产 GLP-1R/GIPR 双激动剂 9 月 2 日，恒瑞医药的 HRS9531 注射液上市申请获得受理，适应症为在控制饮食和增加运动的基础上用于成人的长期体重管理，患者的初始体重指数（BMI）需≥28 kg/m2（肥胖）或≥24 kg/m2（超重），并伴有至少一种体重相关合并症。 截图来源：CDE 官网 HRS9531 是一种同时靶向 GLP-1R 和 GIPR 的双激动剂。2025 年 7 月，HRS9531 注射液 Ⅲ 期临床试验（HRS9531-301）取得成功。研究结果表明，在主要疗效终点和所有关键次要疗效终点上，HRS9531 组显著优于安慰剂组，HRS9531 高剂量组平均体重降低达 19.2%，其中 44.4% 的受试者体重降低≥20%，而且安全性和耐受性良好。 Insight 数据库显示，在 GLP-1R/GIPR 双靶点新药赛道，全球现仅有礼来的替尔泊肽获批上市。恒瑞的 HRS9531 是首个报上市的国产 GLP-1R/GIPR 双激动剂。此外，还有多款同靶点新药在国内进入了 Ⅲ 期，来自翰森制药、博瑞生物、安进、众生药业、华东医药。 箕星药业/LENZ：盐酸醋克利定滴眼液 首个老花眼滴眼液 9 月 9 日，箕星药业和 LENZ Therapeutics 联合递交的盐酸醋克利定滴眼液上市申请获得受理，适应症为老视（俗称老花眼）。 截图来源：CDE 官网  LNZ100（盐酸醋克利定）是 LENZ 公司开发的一种以醋克利定为基础的滴眼液，主要用于改善老花眼患者的近视力。箕星药业拥有 LNZ100 在大中华区的开发和商业化独家权益。 今年 7 月 31 日， LNZ100 已在美国获批上市，成为了首个获批的老花眼眼药水。在国内，LNZ100（1.75% 醋克利定）用于治疗中国老视患者的 III 期临床研究 JX07001 已取得成功。 中国 Ⅲ 期研究数据显示，LNZ100 达到了主要终点和关键次要终点，最佳远矫正下的近视力 (BCDVA) 有三行或更佳的显著改善，并保持其最佳远视力（即视力下降不可超过 5 个字母）。而且大多数受试者在服用 LNZ100 后 30 分钟内就能起效，疗效可维持 10 个小时。 康宁杰瑞/石药集团：安尼妥单抗 首个国产 HER2 双抗 9 月 12 日，康宁杰瑞和石药集团津曼特生物申报的安尼妥单抗注射液上市申请获得受理，适应症为用于 HER2 阳性局部晚期、复发或转移性的胃/胃食管结合部腺癌二线治疗。该申请已被纳入优先审评。 截图来源：CDE 官网 KN026 是康宁杰瑞自主研发的一种 HER2 双抗。2021 年 8 月，石药集团旗下津曼特生物与康宁杰瑞达成一项 10 亿元授权合作，获得了 KN026 在中国内地在乳腺癌、胃癌适应症上的排他性开发与独占性商业化许可权。 2024 年 ESMO 大会上公布的 II 期临床研究结果显示：KN026 联合化疗的客观缓解率为 40.0%，经独立评审委员会 (IRC) 评估的中位无进展生存期为 8.6 个月，中位总生存期为 13.2 个月。 本次上市申请主要是基于一项关键 II/III 期临床试验（KC-WISE）。III 期研究首次期中分析结果显示：与目前的标准治疗相比，KN026 联合化疗可显著提高患者的临床疗效，延长 PFS 和 OS，且无新发安全性风险，心脏毒性发生率低，免疫原性低。 根据 Insight 数据库，目前国内仅有百济神州从 Zymeworks 引进的泽尼达妥单抗一款 HER2 双抗获批上市，用于治疗胆道癌。康宁杰瑞和石药集团的 KN026 是首个报上市的国产 HER2 双抗，首发适应症为胃癌。 科伦博泰：仑博替尼 首个国产 RET 抑制剂 9 月 22 日，科伦博泰的富马酸仑博替尼胶囊上市申请获受理，适应症为用于治疗 RET 融合阳性局部晚期或转移性非小细胞肺癌 (NSCLC) 成人患者。此前，国内仅有两款进口 RET 抑制剂获批，仑博替尼是首个报上市的国产 RET 抑制剂。 截图来源：CDE 官网 仑博替尼（A400）是一款新型下一代选择性 RET 抑制剂，拟开发用于治疗 NSCLC、甲状腺髓样瘤以及其它 RET 变异的高患病率实体瘤，具有克服第一代选择性 RET 抑制剂耐药的潜力。 本次上市申请是基于 KL400-I/II-01 研究中的两个关键 Ⅱ 期队列治疗一线和二线及以上 RET 融合阳性 NSCLC 的积极结果。数据显示，两个关键临床研究队列已达到主要有效性终点，RET+ NSCLC 一线治疗的 ORR 为 80.8%，二线以上晚期 RET+ NSCLC 的 ORR 为 69.7%。同时，仑博替尼还展示出了可管理的耐受性和安全性。 2021 年 3 月，科伦博泰已将仑博替尼在大中华区及部分亚洲国家之外的开发、制造及商业化独家权益授权给了英国 Ellipses Pharma 公司（研发代号为 EP0031）。在海外，仑博替尼已获得美国 FDA 授予快速通道资格，用于治疗 RET 融合阳性 NSCLC，并正在美国、英国、欧盟和阿联酋开展临床试验。 信立泰：泰卡西单抗 第 5 款国产 PCSK9 单抗 9 月 19 日，信立泰的泰卡西单抗注射液上市申请获得受理，适应症为用于高胆固醇血症和混合型血脂异常。这是第 5 款报产的国产 PCSK9 单抗。 截图来源：CDE 官网 目前国内已有 7 款 PCSK9 靶向疗法获批，其中只有诺华的英克司兰钠是 siRNA，其它 6 款都是 PCSK9 单抗，分别来自安进、赛诺菲、信达、康方、君实、恒瑞。值得一提的是，由于全球原料供应短缺以及优化心血管市场的策略和管线等原因，赛诺菲将停止波立达 (阿利西尤单抗) 在中国市场的推广，并将逐步退出中国市场。 信立泰公告指出，国内已上市的 PCSK9 单抗，若每 4 周一次皮下注射，需要同时注射 2-3 针或无菌配药。而泰卡西单抗虽然也是每 4 周一次皮下注射，但一次只需一针，有望大幅提升患者用药便利性和治疗依从性。 智翔金泰：泰利奇拜单抗 第 3 款国产 IL-4Rα 单抗 9 月 11 日，智翔金泰泰利奇拜单抗（GR1802）注射液上市申请获得受理，适应症为中、重度特应性皮炎。这是第 3 款报产的国产 IL-4Rα 单抗。 截图来源：CDE 官网 GR1802 用于中、重度特应性皮炎适应症的 III 期临床试验已达到了主要疗效终点。除了特应性皮炎，GR1802 还正在开展针对慢性鼻窦炎伴鼻息肉、慢性自发性荨麻疹、成人季节性过敏性鼻炎、青少年季节性过敏性鼻炎适应症的 Ⅲ 期临床。 根据 Insight 数据库，目前全球共有两款  IL-4Rα 单抗获批上市，分别为赛诺菲/再生元的度普利尤单抗、康诺亚/津曼特生物的司普奇拜单抗。其中，度普利尤单抗是全球首个获批的 IL-4Rα 单抗，2024 年全球销售额为 140.89 亿美元，2025 上半年销售额为 73.12 亿欧元（约 80 亿美元）。 在国内，除了已获批的度普利尤单抗和司普奇拜单抗，康乃德/先声药业的乐德奇拜单抗、智翔金泰的泰利奇拜单抗已申报上市。此外，还有 7 款在研产品正在开展 Ⅲ 期临床，来自正大天晴/博奥信、恒瑞、康方、荃信生物、三生国健、麦济生物、齐鲁，竞争非常激烈。 复星医药：布瑞基奥仑赛 第二款 CAR-T 报上市 9 月 24 日，复星医药旗下复星凯瑞（曾用名复星凯特）的布瑞基奥仑赛注射液上市申请获受理，适应症为复发或难治性前体 B 细胞急性淋巴细胞白血病（ALL）成人患者。 来源：CDE 官网 布瑞基奥仑赛（Brexucabtagene autoleucel、KTE-X19）是吉利德科学旗下 Kite Pharma 开发的一种靶向 CD19 的 CAR-T 细胞疗法。此前，该药已在美国、欧盟、加拿大等国家和地区获批上市，用于治疗套细胞淋巴瘤、B 细胞急性淋巴细胞白血病（B-ALL）。 复星凯瑞拥有布瑞基奥仑赛在中国内地、香港、澳门地区的权益，目前正在中国内地开展布瑞基奥仑赛治疗套细胞淋巴瘤、B-ALL 的单臂 Ⅱ 期临床。今年 6 月，复星凯瑞公布了 KTE-X19 在中国 R/R B-ALL 患者中的桥接注册临床研究的最新结果，该试验主要终点为中心评估的 CR/CR 伴不完全血液学恢复（CRi）率。 截至 2024 年 10 月 28 日，共纳入 28 例患者接受 KTE-X19 回输（1×10⁶ CAR-T 细胞/kg）。疗效性数据显示：中位随访 8.1 个月时，CR/CRi 率为 78.6%；中位 DOR、中位 RFS 和中位 OS 均未达到，所有应答者的 MRD 检测结果均为阴性（100%）。安全性数据显示，在中国人群中未观察到新的安全性信号。 此前，复星凯瑞从 Kite Pharma 引进的 CD 19  CAR-T 阿基仑赛已在国内获批，用于治疗弥漫性大 B 细胞淋巴瘤、原发纵隔大 B 细胞淋巴瘤。 除了上述产品，还有多款新药也在本月向 CDE 递交了首次上市申请，限于篇幅本文不再一一介绍。如欲了解更多国内新药注册情况，可前往 Insight 数据库查看。 Insight 数据库整理了 2025 年全球新药申报上市清单，扫描下方二维码 👇，回复关键词 新药报上市 即可免费获取（每月初更新一次，目前更新至 8 月）。 封面来源：站酷海洛 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn