Visus initiates phase 3 trial of Brimochol PF to treat presbyopia
The first of two pivotal phase 3 trials that will assess the safety and efficacy of Brimochol PF for the treatment of presbyopia is underway, according to a press release from Visus Therapeutics.
Healio/Ocular Surgery News Presbyopia Section Editor George O. Waring IV, MD, FACS, said the initiation of the trial is an important step in the expanding market of presbyopia treatments.
“With more than 128 million presbyopes in the United States and over 2 billion worldwide, the market and interest for presbyopia treatments is at an all-time high,” Waring told Healio/OSN. “We are excited to see the expansion in the market for more treatment options which will allow for a more customized approach to the various stages of lens dysfunction.”
The preservative-free topical ophthalmic solution will be evaluated in the double-masked, randomized, multicenter BRIO-I and BRIO-II trials, which will comprise about 170 patients and 500 patients with emmetropic phakic and pseudophakic presbyopia, respectively. The percentage of patients who gain three lines of binocular near visual acuity without losing one line of distance vision will serve as the primary endpoint of BRIO-I.
“The currently approved therapeutic option only shows statistically significant benefits on the near visual acuity primary endpoint out to 3 hours, which does not meet the needs of typical patients who desire to take just one eye drop in the morning to achieve near vision improvement for the duration of their 8-hour-plus day,” Ben Bergo, co-founder and CEO of Visus, said in the release. “Given the encouraging results of our phase 2 VIVID study, we are optimistic that Brimochol will provide this meaningful increase in near vision improvement that we believe will be a primary driver for patient preference in this category.”
In 2021, Visus reported positive results from the VIVID study, which evaluated the safety and efficacy of Brimochol, Brimochol F (carbachol and brimonidine tartrate) and a similarly formulated preservative-free carbachol in 85 patients. For all formulations, at least 83% of patients reached the endpoint of three lines of improved binocular near visual acuity in mesopic conditions without losing one line of distance visual acuity at 1 hour; 82% met this endpoint at 3 hours, 52% at 7 hours and 35% at 9 hours.
The first readout from BRIO-I is expected in the fourth quarter.