Drugs and FDA
FDA expands Ryzumvi approval to treat presbyopia
Ryzumvi is now approved for presbyopia, with phase III trial results showing improved near vision for some patients.
The FDA expanded approval of phentolamine ophthalmic solution 0.75% (Ryzumvi) to include presbyopia, according to Opus Genetics and Viatris. The eye drops are designed to improve near vision while preserving distance vision. Support came from the phase III VEGA-2 and VEGA-3 trials, both of which met their primary endpoint.
In VEGA-3, 569 adults ages 40-64 years received the eye drops or placebo nightly. The most common adverse events included conjunctival hyperemia (26%) and instillation-site irritation (15%).
