Tenpoint Therapeutics has launched Yuvezzi, the “first and only combination eye drop approved to treat presbyopia” in the United States.1

Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% is the only dual agent presbyopia-correcting eye drop intentionally designed to deliver durability, tolerability, and safety, the company said.

Yuvezzi was studied in two pivotal Phase 3 trials enrolling more than 800 patients, including the world’s largest and longest safety study for presbyopia eye drops.

The company said the solution achieves miosis from 30 minutes up to 10 hours with one drop daily.

The US Food and Drug Administration (FDA) approval of Yuvezzi, previously known as Brimochol PF, was based on the BRIO-I and BRIO-II studies.

BRIO I study demonstrated a superior benefit of the combination therapy over the individual actives – a requirement for FDA approval of a fixed-dose combination.2

In BRIO II, which was vehicle-controlled, Yuvezzi achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUNVA) over eight hours, without the loss of one line or more in binocular uncorrected distance visual acuity (BUDVA).3

Yuvezzi was well-tolerated with no treatment-related serious adverse events observed in the more than 72,000 treatment days monitored in BRIO II. The most common side effects were headache, impaired vision, and temporary eye pain or eye irritation.4

References available at mivision.com.au.