Topical medical solutions for treating presbyopia are gaining momentum as Visus Therapeutics announced the Phase 3 trials (BRIO-I and BRIO-II) to evaluate the safety and efficacy of its lead asset Brimochol PF have begun. Brimochol PF is a preservative-free, fixed-dose combination of carbachol (a cholinergic miotic agent) and brimonidine tartrate (an alpha-2 agonist) topical ophthalmic solution for the treatment of presbyopia.
Both formulations work by producing a “pinhole effect” — by reducing the size of the pupil, light rays focused on the retina can enter the eye, thereby sharpening vision while mitigating side effects — and resulting in clarity of vision for near and intermediate tasks.*
Phase 2 data showed that Brimochol PF and Carbachol PF were well-tolerated and met clinical outcomes. This supported advancement to Phase 3 trials, where the company seeks to demonstrate their proprietary solution is a safe and effective once-daily eye drop to correct the loss of near vision associated with presbyopia.
BRIO-I and BRIO-II are double-masked, randomized, multi-center, safety and efficacy studies. They expect to enroll approximately 170 emmetropic phakic and 500 pseudophakic presbyopic patients. Investigators are looking for a primary efficacy endpoint in the percentage of patients who gain three lines of improvement in binocular near visual acuity without losing one line of distance vision. The company expects the first read out from the study in Q4 2022.
Currently, Vuity (Allergan, an AbbVie Company) is the first and only eye drop approved by the U.S. Food and Drug Administration (FDA) to treat presbyopia.
“The currently approved therapeutic option only shows statistically significant benefits on the near visual acuity primary endpoint out to three 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 eight-hour-plus day,” Ben Bergo, co-founder and CEO at Visus Therapeutics, said in a press release.
“Given the encouraging results of our Phase 2 VIVID study, we are optimistic that Brimochol PF will provide this meaningful increase in near vision improvement that we believe will be a primary driver for patient preference in this category,” he continued.
“The gold standard for dosing with eye drop therapeutics is once per day, and for a quality-of-life medication without insurance reimbursement, the distinction between a drop that lasts a few hours and a drop that lasts throughout the workday will be even more pronounced.”
“The response rates of our formulations appear to be much higher over an extended period of time than the commercially available therapy as well as the therapies in development, according to clinical studies,” said Dr. Rhett Schiffman, co-founder, chief medical officer and head of research and development at Visus Therapeutics. “We anticipate the Phase 3 trial will generate the pivotal data required to support our New Drug Application, bringing us one step closer to offering a novel, preservative-free therapy for patients.”
*McLaurin E, Cavet ME, Gomes PJ, Ciolino JB. Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial. Optom Vis Sci. 2018;95(3):264-271.