Visus Therapeutics completes enrollment in BRIO-I Phase 3 clinical trial of Brimochol PF for the treatment of presbyopia

The BRIO-I Phase 3 clinical trial is a double-masked, randomized, multi-center, safety and efficacy study that enrolled emmetropic phakic and pseudophakic presbyopic subjects. (Image credit: Adobe Stock/Vitalii Vodolazskyi)

Visus Therapeutics Inc. announced it has completed patient enrollment and the last patient visit has been conducted in BRIO-I, a pivotal Phase 2 trial for its lead asset, Brimochol PF, a preservative-free topical ophthalmic solution for the treatment of presbyopia.

Ben Bergo, co-founder and CEO of Visus Therapeutics, said in a news release that the company is pleased to reached this milestone in the BRIO-I study, as part of its Phase 3 program.

“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,” Bergo said in the release.

According to the company, BRIO-I is a double-masked, randomized, multi-center, 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 company noted in its news release 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. In addition to increasing the magnitude and duration of carbachol on the pupil in non-clinical and clinical studies, brimonidine is also known to cosmetically whiten the eye.¹

Rhett Schiffman, MD, MS, MHSA, co-founder and chief medical officer and head of research and development at Visus Therapeutics, pointed out in the news release the study is focusing on the safety and efficacy of the candidate.

“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,” Schiffman said in the release. “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.”

Reference

1. McLaurin, E., Cavet, M. E., Gomes, P. J., & Ciolino, J. B. (2018). Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial. Optometry and vision science : official publication of the American Academy of Optometry, 95(3), 264–271.