▎WuXiEdited by Kant Content Team

Today, Tenpoint Therapeutics announced the positive topline results of its second Phase 3 pivotal trial, BRIO-II. The analysis showed,The trial met the pre-specified primary endpoint agreed upon with the U.S. FDA, European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA)., the Brimochol PF eye drops developed by it can significantly improve patients' near vision compared to the control group, with effects lasting up to 8 hours.This means that patients only need to apply a few drops of eye drops in the morning, and their near vision will be improved for almost the entire day!This positive outcome supports the company's plan to submit the therapy's marketing application in the first half of 2025.

BRIO-IIIs a project that includes3A multi-center, randomized, double-blind study assessing safety and efficacyBrimochol PFEfficacy and Safety of Eye Drops Compared with Carbachol Monotherapy Eye Drops and Placebo Eye Drops in Presbyopic Patients with Normal Vision (No Myopia or Hyperopia): A Study Recruiting629Subject.

The analysis shows that, compared with the control group,Brimochol PF significantly improved patients' near vision at all time points (up to 8 hours) (p<0.008). Brimochol PF also demonstrated clinically and statistically significant pupil-constricting effects at all time points.Pupil constriction is the key mechanism of action for miotic agents, correcting near vision loss and increasing depth of field by creating a pinhole effect.Brimochol PF achieves this effect while also improving distance vision and gradually eliminating pupil constriction over 10 hours. As pupil constriction decreases later in the day, the risk of night vision difficulties may be reduced.No rapid tolerance to the effects on vision or pupil function was observed during the 12-month at-home dosing phase.

Image Source: 123RF

Brimochol PF was well-tolerated during the 12-month period of daily administration, with no serious treatment-related adverse events. Additional analyses showed that Brimochol PF significantly improved patients' reading speed and patient-reported quality of life outcomes based on the NEI Refractive Error Quality of Life Questionnaire.

Brimochol PF combines two approved drugs: carbachol and brimonidine. The miotic agent carbachol may stimulate the contraction of the ciliary muscle, which controls the shape of the lens, while reducing the pupil size. This can alter the refractive properties of the lens by changing its shape and lead to a decrease in distance vision.Patients who frequently receive treatment may also experience side effects such as headaches, myopic displacement, and red eyes. Brimonidine is an α2 receptor agonist that can inhibit the contraction of ciliary muscles and reduce red eyes. It can also increase the half-life of carbachol, allowing its effect to last 8-12 hours, which means that applying the eye drops in the morning may last all day.

References:

[1] Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II, of BRIMOCHOL™ PF for the Treatment of Presbyopia. Retrieved January 9, 2025 from https://www.businesswire.com/news/home/20250109824922/en

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. If you need guidance on treatment options, please visit a正规 hospital.

Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain reprint guidelines.