FDA Expands Ryzumvi’s Approved Uses to Adult Presbyopia

The FDA has approved Ryzumvi for presbyopia in adults, adding an age-related near-vision use to an eye drop previously approved to reverse drug-induced pupil dilation. Ryzumvi is a 0.75% phentolamine ophthalmic solution. Its previous indication covered adults and children 3 years and older with pharmacologically induced pupil dilation. The approval was supported by Phase 3 trials VEGA-2 and VEGA-3. Both met their primary and key secondary efficacy endpoints, and no treatment-related serious adverse events were reported.

Source: TokenPost