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)--Tenpoint Therapeutics, Inc., a global, clinical-stage biotech company developing groundbreaking treatments to rejuvenate vision in the aging eye, today reported positive topline results from BRIO-II, the company’s second Phase 3 pivotal trial. BRIO-II met the pre-specified primary endpoints agreed upon with the U.S.

)--Tenpoint Therapeutics，Inc.是一家全球性的临床阶段生物技术公司，正在开发开创性的治疗方法，以恢复衰老眼睛的视力，今天报道了该公司第二个3期关键试验BRIO-II的阳性结果。BRIO-II符合与美国商定的预先指定的主要终点。

FDA, and European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA), demonstrating statistically significant improvements in near vision versus vehicle at all timepoints out to 8 hours (p<0.008)..

FDA、欧洲药品管理局（EMA）和英国药品和保健品管理局（MHRA），在8小时内的所有时间点，与车辆相比，近视力均有统计学意义上的显著改善（p<0.008）。。

BRIMOCHOL™ PF also demonstrated clinically and statistically significant reductions in pupil size at all timepoints. The reduction in pupil size is the key mechanism of action for the miotic class of therapies creating a pinhole effect that corrects for the loss of near vision and increases depth of focus.

BRIMOCHOL™PF还显示出在所有时间点瞳孔大小的临床和统计学显着减少。瞳孔大小的减小是瞳孔缩小类疗法的关键作用机制，该疗法产生针孔效应，可纠正近视力丧失并增加聚焦深度。

BRIMOCHOL™ PF accomplishes this while improving distance vision and providing a gradual resolution of miosis over 10 hours. Less miosis later in the day may minimize difficulties with night-time vision. No tachyphylaxis was observed in either vision or pupil effects over the duration of the 12-month at-home dosing phase of the study..

BRIMOCHOL™PF可以实现这一点，同时可以改善远视力，并在10小时内逐渐解决瞳孔缩小问题。白天晚些时候缩小瞳孔可能会减少夜间视力的困难。在研究的12个月家庭给药阶段的持续时间内，视力或瞳孔效应均未观察到快速反应。。

BRIMOCHOL™ PF was well-tolerated over a 12-month daily dosing period with no treatment-related serious adverse events. In additional analysis, BRIMOCHOL™ PF significantly improved reading speed and patient-reported quality of life outcomes based on the NEI-Refractive Error Quality of Life questionnaire.

BRIMOCHOL™PF在12个月的每日给药期间耐受性良好，没有与治疗相关的严重不良事件。。

Further details will be presented at upcoming scientific meetings..

更多细节将在即将举行的科学会议上介绍。。

“Tenpoint Therapeutics is the only company in the presbyopia category to demonstrate contribution of elements with BRIMOCHOL™ PF, paving the way for a combination drug approval that offers the additional benefits of brimonidine,” said Rhett Schiffman, M.D., M.S., M.H.S.A., Chief Medical Officer and Head of Research and Development.

“Tenpoint Therapeutics是老视类别中唯一一家证明BRIMOCHOL™PF元素贡献的公司，为获得联合用药批准铺平了道路，该药物可以提供溴莫尼定的额外益处，”首席医疗官兼研发负责人Rhett Schiffman，M.D.，M.S.，M.H.S.a.说。

“In our studies, brimonidine increased the magnitude and duration of action of carbachol and reduced the incidence of hyperemia (eye redness) over carbachol alone. BRIMOCHOL™ PF is the only presbyopia correcting eyedrop to have gone through a 12-month safety study. It was very well-tolerated over 12 months of continuous dosing and subjects in the study reported very high compliance during the study and a strong willingness to use the drug.

“在我们的研究中，与单独使用卡巴胆碱相比，溴莫尼定增加了卡巴胆碱的作用幅度和持续时间，并降低了充血（眼睛发红）的发生率。BRIMOCHOL™PF是唯一经过12个月安全性研究的老视矫正滴眼液。连续给药12个月后，耐受性非常好，研究对象报告在研究期间依从性很高，并且强烈愿意使用该药物。

We are very grateful to the investigators, their staff, and the study participants for their enormous efforts in this groundbreaking trial.”.

我们非常感谢调查人员，他们的工作人员和研究参与者在这项开创性的试验中做出的巨大努力。”。

BRIO-II is a 3-arm, multicenter, randomized, double-masked, safety and efficacy study of BRIMOCHOL™ PF (carbachol/brimonidine tartrate fixed-dose combination) topical ophthalmic solution vs. carbachol monotherapy topical ophthalmic solution vs. a vehicle topical ophthalmic solution in subjects with emmetropic phakic or pseudophakic presbyopia (.

BRIO-II是一项针对BRIMOCHOL™PF（卡巴胆碱/酒石酸溴莫尼定固定剂量组合）局部眼用溶液与卡巴胆碱单药治疗局部眼用溶液与载体局部眼用溶液的三臂，多中心，随机，双盲，安全性和有效性研究，用于正视性有晶状体眼或假晶状体老视患者（。

NCT05135286

时间05135286

). The study enrolled 629 subjects across 47 sites in the United States.

)。该研究在美国47个地点招募了629名受试者。

“I am very pleased to see that BRIMOCHOL™ PF was not only well-tolerated over a 12-month dosing study but also achieved a functional improvement in reading speed, something that patients really care about,” said John Hovanesian, M.D., a member of Company’s Medical Advisory Board. “BRIMOCHOL™ PF has demonstrated a profile that, if approved, will meet the needs for a large proportion of presbyopes and I’m excited for the product to become a reality for patients.”.

“我很高兴看到BRIMOCHOL™PF在12个月的剂量研究中不仅耐受性良好，而且在阅读速度方面也取得了功能改善，这是患者真正关心的，”该公司医学顾问委员会成员约翰·霍瓦尼西安医学博士说。“BRIMOCHOL™PF展示了一个配置文件，如果获得批准，将满足大部分老花眼的需求，我很高兴该产品成为患者的现实。”。

About Tenpoint Therapeutics

关于Tenpoint Therapeutics

Tenpoint Therapeutics Limited is a global, clinical-stage biotech company developing groundbreaking treatments to rejuvenate vision in the aging eye. Its pipeline includes paradigm-shifting treatments for ophthalmic indications with the greatest need and global market potential, including presbyopia, cataracts and geographic atrophy.

Tenpoint Therapeutics Limited是一家全球性的临床阶段生物技术公司，开发开创性的治疗方法，以恢复衰老眼睛的视力。其管道包括针对最有需求和全球市场潜力的眼科适应症的范式转换治疗，包括老视，白内障和地理萎缩。

Its lead asset, BRIMOCHOL™ PF, is a novel, pupil-modulating therapeutic designed to correct the loss of near vision associated with presbyopia, a condition that afflicts approximately 2 billion people globally. BRIMOCHOL™ PF has completed two large phase 3 pivotal trials (BRIO-I and BRIO-II) and the company plans to file the US NDA, in the first half of 2025.

它的主要资产BRIMOCHOL™PF是一种新颖的瞳孔调节疗法，旨在纠正与老视相关的近视力丧失，老视是全球约20亿人的疾病。BRIMOCHOL™PF已完成两项大型3期关键试验（BRIO-I和BRIO-II），该公司计划在2025年上半年提交美国NDA。

This topical ophthalmic is poised for launch in 2026. Tenpoint’s leadership team includes ophthalmic industry luminaries with track records of successful approvals and commercialization of blockbuster drugs. A privately held company, Tenpoint Therapeutics is backed by AdBio Partners, British Patient Capital, Eight Roads, EQT Life Sciences, F-Prime Capital, Hillhouse Capital Management, Qiming Venture Partners USA, Sofinnova Partners, and UCL Technology Fund.

这种局部眼科药物准备于2026年推出。Tenpoint的领导团队包括眼科行业的杰出人士，他们曾成功批准和商业化重磅炸弹药物。。

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