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.
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.
