Visus Therapeutics reports positive phase 2 results for three presbyopia formulations
Three topical ophthalmic formulations designed to treat presbyopia demonstrated positive results in the phase 2 VIVID clinical trial, Visus Therapeutics announced in a press release.
Based on these results, the company is planning to start phase 3 pivotal trials.
The trial compared the safety and efficacy of fixed-dose combinations of Brimochol and Brimochol F (carbachol and brimonidine tartrate) and a similarly formulated preservative-free carbachol in 85 patients, aged 45 to 80 years, with emmetropic phakic and pseudophakic presbyopia at three U.S. centers.
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.
Additionally, Brimochol and Brimochol F met the secondary endpoint of mean improvement in binocular near visual acuity by at least 18 ETDRS letters as early as 30 minutes after instillation and by at least 12 letters at 9 hours.
All three formulations were well tolerated with no serious adverse events.
“These positive results provide further confidence that we are well positioned to bring to market the longest-lasting eye drop in the presbyopia category, which would be a meaningful breakthrough treatment for these individuals,” Rhett Schiffman, MD, MS, MHSA, co-founder, chief medical officer and head of research and development at Visus Therapeutics, said in the release.
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