Visus Therapeutics has announced positive topline data from its Phase III pivotal BRIO-I trial of BRIMOCHOL PF for the treatment of emmetropic phakic or pseudophakic presbyopia.
The multicentre, randomised, double-masked, crossover, three-arm study has enrolled 182 individuals across 15 US sites.
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It will assess the safety and efficacy of BRIMOCHOL PF (carbachol/brimonidine tartrate fixed-dose combination) topical ophthalmic solution against active comparators carbachol and brimonidine tartrate monotherapy.
The study met the pre-specified visual acuity primary endpoints for both the US and EU/UK against its comparators.
Improvements in near and distance binocular visual acuity at multiple time points were observed in patients using BRIMOCHOL PF.
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In addition, the study demonstrated highly statistically significant reductions in pupil size over ten hours.
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By GlobalDataVisus medical advisory board chair and board of directors’ member Eric Donnenfeld said: “I am pleased to see that BRIMOCHOL PF was superior to both highly active treatments, carbachol and brimonidine, over a range of time points in this study.
“BRIMOCHOL PF was well-tolerated in a broad presbyopia population with no study subjects discontinuing due to adverse events.
“If approved, BRIMOCHOL PF has the potential to last a full workday in presbyopia patients not fully served at this time.”
A loss of near vision associated with ageing, presbyopia is said to impact over 128 million US adults.
