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.
