Visus Therapeutics Completes Enrollment in BRIO-I Phase 3 Trial of Brimochol PF for the Treatment of Presbyopia

Visus Therapeutics announced it has completed patient enrollment and the last visit had been conducted in BRIO-I, a phase 3 trial for its lead asset, Brimochol PF, a preservative-free topical ophthalmic solution for the treatment of presbyopia.

“We are thrilled to have reached this milestone in the BRIO-I study, as part of our phase 3 program,” Ben Bergo, co-founder and chief executive officer of Visus Therapeutics, said in a company news release. “Brimochol PF has the potential to be a highly appealing presbyopia correcting eye drop, providing both the duration and tolerability profile presbyopes desire. We look forward to sharing topline results from BRIO-I in Q2, 2023.”

BRIO-I is a double-masked, randomized, multicenter, safety and efficacy study that enrolled emmetropic phakic and pseudophakic presbyopic subjects.

Brimochol PF is a novel, preservative free, fixed-dose combination of carbachol and brimonidine tartrate that produces a robust and sustained “pinhole effect” by reducing the size of the pupil. This allows only the light rays focused on the retina to enter the eye, thereby sharpening vision. The result is an enhanced and durable clarity of vision for near tasks like reading or using a smartphone, and intermediate tasks such as looking at a computer screen, according to Visus. In addition to increasing the magnitude and duration of carbachol on the pupil in nonclinical and clinical studies, brimonidine is also known to cosmetically whiten the eye.[1]

“BRIO-I is a safety and efficacy study whose primary objective is to evaluate whether a combination drug therapy of carbachol and brimonidine tartrate is superior in improving near vision than each of the two monotherapies dosed individually,” said Rhett Schiffman, MD, MS, MHSA, co-founder, chief medical officer and head of research and development at Visus Therapeutics. “By demonstrating this so-called contribution-of-elements in this study, Visus would become the first company to meet this FDA-required high bar for approving a combination product for presbyopia in a pivotal phase 3 study. We look forward to presenting our results at upcoming meetings in Q2, 2023.”