Add as a preferred source on GoogleFDA Expands Ryzumvi’s Approved Uses to Adult Presbyopia
The 0.75% phentolamine eye drop was previously approved to reverse drug-induced pupil dilation. In a Phase 3 trial, 27.2% of participants met the near-vision endpoint, compared with 11.5% on placebo.
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. commercialization rights under a licensing agreement and is exploring a U.S. partner for the presbyopia use.
Riza Dagoc
Riza Dagoc reports on regulation, investing and the digital-asset business for TokenPost. Send corrections or tips to info@tokenpost.com.