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<![CDATA[FDA Approves Carbachol and Brimonidine Tartrate Ophthalmic Solution for Presbyopia]]>
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HCPLive articles
“Yuvezzi introduces a novel approach by combining carbachol and brimonidine tartrate in a single daily eye drop that sharpens near vision and maintains tolerability throughout the day.”1BRIO I was a 3-arm, multicenter, randomized, double-masked, crossover safety and efficacy study, comparing Yuvezzi to carbachol monotherapy topical ophthalmic solution and brimonidine tartrate monotherapy topical ophthalmic solution in patients with emmetropic phakic or pseudophakic presbyopia.
These effects were maintained out to 10 hours when compared with carbachol and brimonidine monotherapy.
Additionally, Yuvezzi demonstrated statistical significance in the proportion of patients achieving ≥20/40 vision at near visual acuity.
It was the company’s second phase 3 pivotal trial, investigating prespecified endpoints agreed upon with the FDA and the European Medicines Agency.
“I’m excited that I will be able to offer my patients Yuvezzi, the first-of-its-kind eye drop well-suited for long-term use.