Visus Therapeutics Celebrates Positive Results from Phase 3 Pivotal Study of Presbyopia Treatment BRIMOCHOL PF™!

Visus Therapeutics Inc., a clinical-stage pharmaceutical company, has achieved a major milestone in its endeavor to develop therapies for eye conditions. The company has reported positive topline results from its Phase 3 pivotal BRIO-I trial, demonstrating that the once-daily, fixed-dose combination, BRIMOCHOL PF, contributes to the improvement of near and distance binocular visual acuity, and clinically and statistically significant reductions in pupil size out to 10 hours.

Furthermore, the product was observed to be well-tolerated with no treatment-related serious adverse events. These promising results have been agreed upon with the US-FDA and EMA/MHRA, and will be presented at upcoming meetings including Eyecelerator during the 2023 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in San Diego, CA.

Visus Therapeutics is proud to have successfully completed the BRIO-I study – the first of its kind to demonstrate the positive contribution-of-elements in a presbyopia pivotal trial.

The study, which enrolled 182 participants across 15 sites in the United States, compared the effects of BRIMOCHOL PF (carbachol/brimonidine tartrate fixed-dose combination) topical ophthalmic solution to those of carbachol monotherapy and brimonidine tartrate monotherapy. The Visus Therapeutics team is deeply grateful to the investigators, their staff and the study participants for their tireless efforts and contribution.

Visus is thrilled to announce the results of their latest study, which showed that BRIMOCHOL PF outperformed both carbachol and brimonidine in a presbyopia population. Eric Donnenfeld, M.D., Visus Board of Directors member and Chair of the Company’s Medical Advisory Board, commented on the results, saying, “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.

What’s more, BRIMOCHOL PF was well-tolerated with no study subjects discontinuing due to adverse events. If approved, BRIMOCHOL PF holds the potential to provide a full workday of relief for presbyopia patients currently not sufficiently treated by other medications.”

About Presbyopia

As we age, our ability to perform tasks like reading fine print begins to diminish—a condition known as presbyopia. This isn’t just a minor annoyance—it’s a problem that affects billions of people around the world, with 128 million adults in the US alone struggling with it. For those who don’t want to wear glasses, or find them inconvenient, presbyopia can be a real challenge. But luckily, there are solutions that can help make reading easier, and allow us to enjoy the activities we love.

About Visus Therapeutics

Visus Therapeutics is a dynamic, clinical-stage pharmaceutical company with offices in Seattle, Wash. and Irvine, Calif. Our mission is to develop multi-targeted ophthalmic therapies for conditions affecting both the front and back of the eye, utilizing advanced sustained delivery platforms to improve patient outcomes. We are passionate about leading the way in finding innovative solutions to treat and prevent vision impairments.

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