First Dual-agent Drop Approved for Presbyopia

Yuvezzi combines the miotic agent carbachol with brimonidine tartrate, which serves to help maintain pupil constriction for up to 10 hours after instillation. Click image to enlarge. In just a few years, presbyopia management has expanded beyond readers and surgery to include prescription eye drops. The category debuted with the pilocarpine formulations Vuity (Allergan) and Qlosi (Orasis), followed last summer by an aceclidine-based drop, Vizz (Lenz Therapeutics). Yesterday, Tenpoint Therapeutics announced the FDA approval of Yuvezzi—the first preservative-free, fixed‑combination drop for presbyopia that pairs a pupil-constricting agent, carbachol 2.75%, with brimonidine tartrate 0.1%, an alpha‑2 adrenergic agonist that inhibits the iris dilator muscle to create a sustained pinhole effect.The approval of Yuvezzi was preceded by the completion of two Phase III studies, the first of which (BRIO I) showed a superior benefit of the combination therapy vs. drops formulated with a single agent. In the second Phase III study, BRIO II, Tenpoint reports that Yuvezzi achieved all primary near-vision improvement endpoints, enhancing binocular uncorrected near visual acuity (VA) by three lines or more over eight hours without compromising distance acuity (loss of one line or less in binocular uncorrected distance VA).Across clinical trials, Tenpoint says the dual-agent drop was well-tolerated, with no treatment-related serious adverse events observed over 12 months of use. According to data from BRIO II, the most common side effects were headache (15.6%), impaired vision (6.4%) and temporary eye pain (6.7%) or irritation (14%). That trial also reported that the adverse event of ocular hyperemia was less common in patients who received Yuvezzi (2.8%) than those who used carbochol alone (10.7%).The drop is intended to be administered once daily, and Tenpoint says the treatment effect should last from 30 minutes after instillation up to 10 hours. The brimonidine tartrate in the formula is intended to help maintain pupil constriction throughout the day.For more information, go to tenpointtherapeutics.com.