Visus Therapeutics Announces Positive Topline Clinical Data from Phase 3 Trial of Brimochol PF for the Treatment of Presbyopia

Visus Therapeutics reported positive topline results from its phase 3 pivotal BRIO-I trial. BRIO-I met the prespecified primary study endpoints agreed upon with the FDA and EMA/MHRA, demonstrating contribution of elements for the once-daily, fixed-dose combination, Brimochol PF, over both active comparators carbachol and brimonidine monotherapies. Brimochol PF demonstrated highly statistically significant improvements in near and distance binocular visual acuity at multiple timepoints over 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.

Further details will be presented at upcoming meetings, including Eyecelerator during the 2023 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting taking place in San Diego on May 4.

“Visus Therapeutics is the first and only company to demonstrate contribution-of-elements in a presbyopia pivotal study. We are very grateful to the investigators, their staff, and the study participants for their enormous efforts in this trial,” Rhett Schiffman, MD, MS, MHSA, co-founder, chief medical officer and head of research and development at Visus Therapeutics, said in a company news release. 

BRIO-I is a 3-arm, multicenter, randomized, double-masked, crossover safety and efficacy study of Brimochol PF (carbachol/brimonidine tartrate fixed-dose combination) topical ophthalmic solution vs. carbachol monotherapy topical ophthalmic solution vs. brimonidine tartrate monotherapy topical ophthalmic solution in subjects with emmetropic phakic or pseudophakic presbyopia (NCT#: NCT05270863). The study enrolled 182 subjects across 15 sites in the United States.

“I am pleased to see that Brimochol PF was superior to both highly active treatments, carbachol and brimonidine, over a range of timepoints in this study,” said Eric Donnenfeld, MD, Visus Board of Directors member and Chair of the Company’s Medical Advisory Board. “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.”