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. In VEGA-3, 27.2% of participants receiving phentolamine achieved at least a 15-letter improvement in binocular distance-corrected near visual acuity while losing fewer than five letters in binocular best-corrected distance visual acuity, 12 hours after dosing on Day 8. The result was 11.5% among participants receiving placebo. Viatris holds exclusive U.S.

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