Tenpoint Therapeutics’ Yuvezzi, the first and only dual-agent eye drop, has received US Food and Drug Administration (FDA) approval for the treatment of presbyopia in adults.   

The approval of Yuvezzi* (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) is based on positive data from two phase 3 studies. The phase 3 Brio I study demonstrated a superior benefit of the combination therapy over the individual active ingredients – a requirement for FDA approval of a fixed-dose combination. In Brio II, which was vehicle-controlled, Yuvezzi achieved all primary near-vision improvement endpoints with a statistically significant improvement of three lines or more in binocular uncorrected near visual acuity over eight hours, without a loss of one line or more in binocular uncorrected distance visual acuity. 

Yuvezzi was well-tolerated with no treatment-related serious adverse events observed in the more than 72,000 treatment days monitored in Brio II, which, at 12 months, is the longest safety study conducted on a presbyopia treatment to date, the company said. The most common adverse reactions were eye pain upon instillation, visual impairment, eye irritation upon instillation and headache. Eye redness was not a commonly reported side effect in clinical trials of Yuvezzi.  

As the first and only dual-agent eye drop approved to treat presbyopia, Yuvezzi leverages the mechanisms of carbachol and brimonidine tartrate to deliver sharp near vision with favourable tolerability, said Henric Bjarke, CEO of Tenpoint Therapeutics. “People deserve treatments that not only work but also can fit conveniently into their daily lives and Yuvezzi brings an innovative new option to the presbyopia category.” 

Yuvezzi is now commercially available in the US. 

*previously known as Brimochol PF