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<![CDATA[FDA Approves Yuvezzi to Treat Presbyopia in Adults]]>
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Pharmaceutical Executive articles
Tenpoint Therapeutics announced FDA’s approval of Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for the treatment of presbyopia in adults, marking the first FDA-approved dual-agent eye drop for the condition.
“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.
Yuvezzi was intentionally designed to deliver both efficacy and tolerability, which represents an important step forward in delivering a complete, noninvasive option for people with presbyopia.”What is Yuvezzi’s approval based on?
The agency’s approval of Yuvezzi is based on data collected from two Phase III clinical trials, BRIO I and BRIO II, which evaluated the efficacy and safety of the fixed-dose combination.1 In BRIO I, Yuvezzi demonstrated superiority over each individual active component, meeting the FDA’s requirement for approval of combination therapies.
“As the first FDA-approved dual-agent eye drop for presbyopia, Yuvezzi leverages the mechanisms of carbachol and brimonidine tartrate to deliver sharp near vision with favorable tolerability.”Tenpoints’ series B stock financingTo pair with FDA’s approval of Yuvezzi, Tenpoint Therapeutics also announced it has raised a total of $235 million in new capital.