Visus Therapeutics reported positive topline results from its Phase 3 pivotal BRIO-I trial, demonstrating highly statistically significant improvements in near and distance binocular visual acuity at multiple timepoints, compared with carbachol and brimonidine.
Clinically and statistically significant reductions in pupil size were also observed out to 10 hours. BRIMOCHOL PF was well-tolerated with no treatment-related serious adverse events.
“Visus Therapeutics is the first and only company to demonstrate contribution-of-elements in a presbyopia pivotal study,” Rhett Schiffman, M.D., co-founder, CSO and head of research and development at closely-held Visus, said in a statement.
Presbyopia is the loss of near vision associated with aging, making it difficult to perform tasks like reading fine print.
BRIO-I was a three-arm, multicenter, randomized, double-masked, crossover safety and efficacy study of BRIMOCHOL PF topical ophthalmic solution vs. carbachol monotherapy topical ophthalmic solution vs. brimonidine tartrate monotherapy topical ophthalmic solution in subjects with emmetropic phakic or pseudophakic presbyopia. The study enrolled 182 subjects across 15 sites in the United States.
If approved, BRIMOCHOL PF has the potential to last a full workday in presbyopia patients not fully served at this time.
