BRIO-II is a safety and efficacy study consisting of three cohorts, multiple centers, randomized, double-blind studies evaluating the efficacy and safety of Brimochol PF eye drops compared to carbapenem monotherapy eye drops and placebo eye drops in presbyopia patients with normal vision (without myopia or hyperopia). The study recruited a total of 629 participants.
Analysis showed that compared to the control group, Brimochol PF significantly improved patients' near vision at all time points (up to 8 hours) (p<0.008). Brimochol PF also showed clinically and statistically significant pupil constriction effects at all time points. Pupil constriction is a key mechanism of action in the treatment of pupil constriction drugs, which corrects near vision loss and increases depth of field by creating a pinhole effect. Brimochol PF not only achieved this effect, but also improved long-distance vision and gradually eliminated pupil constriction within 10 hours. With the reduction of pupil constriction in the later stages of the day, the risk of night vision difficulties may be reduced. During the 12-month period of home medication, no rapid drug resistance to visual or pupillary effects was observed in the study.
Brimochol PF had good tolerability and no treatment-related serious adverse events during the 12-month daily medication period. Additional analysis showed that Brimochol PF significantly improved patients' reading speed and reported quality of life outcomes based on the NEI Refractive Error Quality of Life Questionnaire.
Brimochol PF combines two approved drugs, Carbachol and Bromonidine. The pupil constrictor carbachol may stimulate the contraction of the ciliary body muscles that control the shape of the crystalline lens, causing changes in its refractive characteristics and leading to a decrease in far vision. Patients who frequently receive treatment may also experience side effects such as headaches, myopia displacement, and red eyes. Bromonidine is an alpha 2 receptor agonist that can inhibit ciliary muscle contraction and reduce red eye. It can also increase the half-life of carbapenem, allowing its effect to last 8-12 hours. This means that a morning drop of eye drops may be effective for the entire day.
<Reprinted from WuXi AppTec>
