FDA Accepts NDA for Brimochol PF to Treat Presbyopia

FDA接受Brimochol PF治疗老花眼的新药申请

June 04, 2025

2025年6月4日

The U.S. Food and Drug Administration (FDA) has officially accepted the New Drug Application (NDA) for Brimochol PF, a novel presbyopia treatment developed by Tenpoint Therapeutics. The Prescription Drug User Fee Act (PDUFA) target action date has been set for January 28, 2026.

美国食品药品监督管理局（FDA）已正式受理Tenpoint Therapeutics公司开发的新型老花眼治疗药物Brimochol PF的新药申请（NDA）。《处方药使用者费用法案》（PDUFA）的目标审批日期定为2026年1月28日。

Brimochol PF: Investigational Combination Therapy for Presbyopia

Brimochol PF：老花眼的在研联合疗法

If approved, Brimochol PF would become the first fixed-dose combination therapy for presbyopia. The formulation combines brimonidine and carbachol to induce a pinhole effect—improving depth of focus and enhancing both near and distant vision. According to Tenpoint, the combination achieves greater peak efficacy and longer duration than either monotherapy alone..

如果获得批准，Brimochol PF 将成为首个用于治疗老花眼的固定剂量复方疗法。该配方结合了溴莫尼定和卡巴胆碱，通过产生针孔效应来改善焦深，并增强近处和远处的视力。据 Tenpoint 称，这种组合比单独使用任何一种单药疗法都能达到更高的峰值效果和更长的作用时间。

“This milestone marks a significant step forward in our transition toward becoming a commercial-stage company,” said Henric Bjarke, CEO of Tenpoint Therapeutics.

“这一里程碑标志着我们在向商业化公司转型过程中迈出了重要的一步，”Tenpoint Therapeutics首席执行官Henric Bjarke表示。

“As the only combination product of its kind, Brimochol PF offers the potential for a best-in-class product. With our commercial leadership team now in place, we are fully engaged in launch preparations and anticipate product availability in 1H 2026.”

“作为同类产品中唯一的组合产品，Brimochol PF 有潜力成为同类最佳产品。随着我们的商业领导团队现已就位，我们正全力投入上市准备，并预计产品将于 2026 年上半年上市。”

Strong Clinical Support from Phase 3 Trials

来自三期试验的强大临床支持

The NDA submission was supported by results from two pivotal phase 3 studies:

新药申请得到了两项关键的三期研究结果的支持：

BRIO-I Study

BRIO-I 研究

• Demonstrated the superior efficacy of the combination therapy compared to individual components, satisfying the FDA’s requirements for fixed-dose combination products.

• 证明了联合疗法相较于单独成分的优越疗效，满足了FDA对固定剂量组合产品的相关要求。

BRIO-II Study (Vehicle-Controlled)

BRIO-II 研究（车辆对照）

• Achieved all primary and secondary endpoints.

• 实现了所有主要和次要终点。

• Showed statistically significant 3-line or greater improvements in binocular uncorrected near visual acuity (BUNVA) over 8 hours.

• 在8小时内，双眼未矫正近视力（BUNVA）显示出统计学上显著的3行或更多行的改善。

• Maintained stable binocular uncorrected distance visual acuity (BUDVA) with no loss of 1 line or more.

• 保持稳定的双眼未矫正远视力（BUDVA），无一行或以上的视力丧失。

• Over 70,000 treatment days were monitored with no serious treatment-related adverse events observed.

监测了超过70,000个治疗日，未观察到严重的与治疗相关的不良事件。

Regulatory Outlook

监管展望

The FDA has indicated it does not plan to convene an advisory committee meeting to discuss the NDA. Tenpoint submitted the application in April 2025, and pending FDA approval, Brimochol PF is expected to launch in the first half of 2026.

美国食品药品监督管理局（FDA）表示不打算召开咨询委员会会议来讨论新药申请（NDA）。Tenpoint于2025年4月提交了申请，待FDA批准后，Brimochol PF预计将于2026年上半年推出。