Visus Therapeutics has completed participant enrolment in the Phase III BRIO-I clinical trial of Brimochol PF to treat presbyopia.
Emmetropic phakic and pseudophakic presbyopic participants were enrolled in the multi-centre, double-masked, safety and efficacy, randomised BRIO-I trial.
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Visus Therapeutics co-founder and CEO Ben Bergo said: “We are thrilled to have reached this milestone in the BRIO-I study, as part of our Phase III programme.
“Brimochol PF has the potential to be a highly appealing presbyopia correcting eye drop, providing both the duration and tolerability profile presbyopes desire.”
The investigational drug Brimochol PF is a preservative free, fixed-dose combination of carbachol and brimonidine tartrate.
It has been designed to be a once-daily eye drop for correcting the loss of near vision that is associated with presbyopia.
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By GlobalDataBy reducing the size of the pupil, the drug produces a sustained and robust “pinhole effect”. This allows only the light rays that are focused on the retina to enter the eye, which results in sharpening vision for near tasks, such as reading or smartphone usage, and looking at a computer screen.
Also known to cosmetically whiten the eye, brimonidine increases the magnitude and duration of carbachol on the pupil in non-clinical and clinical studies.
The company stated that the trial’s primary objective is to assess whether a combination drug therapy of carbachol and brimonidine tartrate is superior in near vision improvement compared to two monotherapies given individually.
Topline data from the Phase III BRIO-I clinical trial are expected in the second quarter of this year.
Visus Therapeutics co-founder, research and development head and chief medical officer Rhett Schiffman said: “By demonstrating this so-called contribution-of-elements in this study, Visus would become the first company to meet this FDA-required high bar for approving a combination product for presbyopia in a pivotal Phase III study.”
