Visus Therapeutics announced positive topline results from its Phase 3 BRIO-I clinical trial, revealing that Brimochol PF, a preservative-free ophthalmic solution, met both primary and secondary endpoints for the treatment of presbyopia. The trial, involving 182 participants aged 45 to 80 across 15 U.S. sites, demonstrated a statistically significant improvement in binocular near visual acuity with the once-daily eye drop.
Primary and Secondary Endpoints Achieved
The BRIO-I trial evaluated Brimochol PF against carbachol and brimonidine tartrate monotherapies in participants with emmetropic phakic or pseudophakic presbyopia. The primary endpoint, based on the proportion of participants achieving a gain of at least 15 ETDRS letters in binocular near visual acuity without a loss of 5 letters or more at distance across all time points through hour 6, was successfully met (carbachol p=0.006; brimonidine p=0.039).
Secondary endpoints also showed statistical significance, including the proportion of participants achieving a gain of 10 letters read at near distance and the proportion achieving at least 20/40 at near visual acuity. Furthermore, Brimochol PF demonstrated a statistically significant gain in distance vision of 2 letters at 8 hours versus active control, carbachol (p=0.047), compared to baseline at all time points (p<0.001).
Favorable Tolerability Profile
Notably, Brimochol PF was well-tolerated among participants, with headache rates below 10% and no treatment-related serious adverse events reported. No participants discontinued treatment due to adverse events, highlighting the potential for a comfortable, once-daily solution.
Contribution of Elements
BRIMOCHOL™ PF is the first fixed-dose combination product to achieve statistically significant “contribution-of-elements” in presbyopia, an FDA requirement for a fixed-dose combination product. The combination of carbachol and brimonidine tartrate in Brimochol PF is designed to provide a greater and longer duration of effect, while minimizing side effects typically induced by miotic agents.
Rhett Schiffman, M.D., M.S., M.H.S.A., co-founder, chief medical officer and head of research and development at Visus Therapeutics, noted that pupillometry results showed clinically and statistically significant reductions in pupil size over the individual therapies at all time points from 30 minutes out to 10 hours (p<0.001).
Market Opportunity and Future Plans
Ben Bergo, co-founder, and chief executive officer at Visus Therapeutics, stated that the positive Phase 3 data provides a clear pathway forward to meet the market need for a once-daily product with a favorable tolerability profile. With approximately 128 million adults affected by presbyopia in the U.S. alone, the need for effective and convenient treatments is significant.
Topline results from the ongoing BRIO-II Phase 3 study are expected in the second half of 2023. Visus Therapeutics anticipates filing a New Drug Application (NDA) with the FDA in the second half of 2024, pending the results of the vehicle-controlled BRIO-II study.
