Visus Presents Topline Clinical Data from Phase 3 Pivotal BRIO-I Trial of Brimochol PF for the Treatment of Presbyopia

Visus Therapeutics presented key topline data from the pivotal phase 3 BRIO-I clinical trial. The study evaluating the safety and efficacy of Brimochol PF, a preservative-free ophthalmic solution for the treatment of presbyopia, met its primary and secondary endpoints.

Brimochol PF successfully achieved the prespecified FDA primary endpoint based on the proportion of subjects achieving >15 ETDRS[1] letter gain in binocular near visual acuity (BUCNVA) without a loss of ≥5 letters at distance across all time points through Hour 6 (carbachol P=0.006; brimonidine P=0.039).

“With the completion of our BRIO-I study and positive phase 3 data in hand, we see a clear pathway forward,” said Ben Bergo, co-founder, and chief executive officer at Visus Therapeutics. “We believe the success of the study represents a strong opportunity to meet the market need for a true once-daily product with a very favorable tolerability profile.”

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, according to Visus. Brimochol PF is also the first fixed-dose combination product to achieve prespecified EU and UK primary endpoints from 0.5 to 8 hours duration (carbachol P=0.003; brimonidine P=0.001) and out to 10 hours (carbachol P=0.004; brimonidine P=0.001). Brimochol PF also demonstrated statistical significance in prespecified secondary endpoints in (1) proportion of subjects achieving a 10-letter gain in letters read at near distance, and in (2) proportion of subjects achieving at least 20/40 at near visual acuity. There was also 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).

“We are very pleased by the BRIO-I topline data demonstrating a rapid and durable improvement in near visual acuity and clear contribution-of-elements with Brimochol PF performing better than each of the individual components separately,” said Rhett Schiffman, MD, MS, MHSA, co-founder, chief medical officer and head of research and development at Visus Therapeutics. “The contribution of brimonidine on the overall performance of Brimochol PF is most clearly shown in the objective pupillometry results that show 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). Importantly, there is a gentle wearing-off of this miotic effect over 10 hours that is still sufficient to provide clinically meaningful improvements in visual performance over a full workday, while minimizing the likelihood of nighttime vision difficulties that can occur if miosis lasts too long. The appeal of this profile was reflected by the subjects in their masked, self-reported assessments who rated the duration of Brimochol PF, on average, as 'just right' and reported that they would expect to use Brimochol PF approximately 5 days a week.”

Brimochol PF was well-tolerated with headache rates of less than 10% and no treatment-related serious adverse events were reported. There were no discontinuations due to adverse events.

Topline results from BRIO-II, an ongoing pivotal phase 3, 6-month plus 6-month safety and efficacy interim study are expected in 2H 2023. Following the read-out of the vehicle-controlled BRIO-II, the company plans to file a new drug application (NDA) with the FDA in 2H 2024.

References

¹ ETDRS = Early Treatment of Diabetic Retinopathy Study

² U.S. Census Bureau. Retrieved May 1, 2023, from http://www.census.gov.

³ Zebardast et al. The Prevalence and Demographic Associations of Presenting Near-Vision Impairment Among Adults Living in the United States. Am J Ophthalmol. 2017; 174:134-144.

⁴ U.S. Census Bureau. Table 9. Washington: Population Division. 2014.