Aceclidine/Brimonidine

LENZ Therapeutics on Thursday said it secured FDA approval for Vizz (aceclidine ophthalmic solution), marking the first aceclidine-based eye drop authorised to treat presbyopia in adults, with the product slated to hit the shelves in the fourth quarter.Eef Schimmelpennink, chief executive of LENZ, said the availability of Vizz — intended for once daily administration — boosts “treatment options for the 128 million adults living with blurry near vision” in the country.The approval was supported by three late-stage studies — the pivotal brimonidine-controlled CLARITY 1 and vehicle-controlled CLARITY 2 trials assessing the eye drop’s safety and efficacy with once-daily dosing over 42 days, and CLARITY 3 evaluating long-term safety over six months.Results showed that Vizz (previously known as LNZ100) met all primary and secondary near vision improvement endpoints in both pivotal studies, demonstrating rapid onset within 30 minutes and sustained efficacy lasting up to 10 hours, alongside reproducible and consistent near vision improvement. Meanwhile, Vizz was well-tolerated, with no serious treatment-related adverse events reported over 30,000+ treatment days across all three CLARITY trials.LENZ also investigated another candidate LNZ101 — a combination of aceclidine and brimonidine — which failed to show superiority to Vizz despite meeting all endpoints in CLARITY 1 and 2, prompting the company to drop the former.Nipping at Vizz’s heels is Tenpoint Therapeutics’ Visus-derived Brimochol PF, a fixed-dose combination of carbachol and brimonidine tartrate, which demonstrated upbeat findings in a pair of Phase III presbyopia studies — BRIO-I and BRIO-II. Tenpoint recently filed a marketing application with the FDA and hopes for a product launch in the first half of next year.

7月28日，LENZ Therapeutics宣布合作伙伴箕星药业（Corxel Pharmaceuticals）已在中国递交LNZ100滴眼液（1.75%醋克利定）的上市申请，用于治疗老视（俗称“老花眼”）。若顺利获批，该药物将成为中国首个用于改善老视患者近视力的滴眼液。LNZ100是LENZ Therapeutics开发的一种不含防腐剂、使用频率为每日1次的醋克利定滴眼液。醋克利定可引起瞳孔暂时性收缩，从而产生显著延长视程、改善近视力和视觉质量的光学效应。与毛果芸香碱和卡巴胆碱等其他瞳孔缩小剂不同，醋克利定的作用机制是瞳孔选择性的，这意味着它可以激活虹膜括约肌，使瞳孔缩小到直径2毫米以下，而不会过度刺激睫状肌，导致近视偏移和远视力受损。因此，醋克利定不需要任何剩余的调节来改善近距离视力，从而扩大了其对晶状体失去调节能力的老年老花眼的益处。2022年4月，LENZ Therapeutics与箕星药业就在大中华区开发和商业化针对老视治疗的LNZ100和LNZ101达成独家许可协议。此次上市申请得到了III期JX07001研究的支持。该研究是一项多中心、随机、双盲、安慰剂对照临床试验，由4周疗效试验和总计6个月的安全性试验组成，旨在观察LNZ100改善中国老视人群近视力并确证其疗效与安全性。研究共招募了300例受试者，符合条件的受试者年龄在45~75岁之间，屈光范围为-4.0D SE至 +1.0D SE，包括曾接受过激光矫正视力手术/单焦点人工晶体植入手术者。结果表明，该研究达到了主要终点和关键次要终点，即LNZ100组受试者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）。老视是指随着年龄增长，看近处的物体逐渐模糊的生理现象，其原因是眼部晶状体逐渐硬化及弹性减弱，从而引起眼的调节功能下降，无法将近处物体的像聚焦在视网膜上，导致近视力下降。老视是一种随着年龄增长不可避免的生理现象，研究显示在中国老视发病年龄在38岁左右，在52岁时发病率接近100%。据估计，中国约有4亿例老视患者。目前老视治疗手段非常有限。佩戴眼镜需要频繁摘戴，给工作及生活带来诸多不便。手术作为侵入性、不可逆的有创操作，接受程度十分有限。目前中国尚未有老视治疗药物获批，在非侵入性、安全有效且可逆的药物治疗方面，老视领域存在着巨大的未满足医疗需求。 END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001