FDA Approves Ryzumvi 0.75% for Adult Presbyopia

Key Takeaways

• The FDA authorized a Ryzumvi treatment indication for adults with presbyopia in the United States.
• The FDA waived pediatric studies because presbyopia does not occur in pediatric patients.

The US Food and Drug Administration (FDA) reviewed a prior-approval supplement to new drug application (NDA) 217064/S-005 for Ryzumvi (phentolamine mesylate ophthalmic solution) 0.75%, seeking a treatment indication for adult presbyopia.

The FDA approved Ryzumvi’s adult-presbyopia indication, effective on the October 16, 2026, electronically signed letter date, for use in accordance with the enclosed agreed-upon labeling. The FDA separately waived required pediatric studies because presbyopia does not occur in pediatric patients, making the studies impossible or highly impracticable.

The FDA directed submission of the approved labeling in structured product labeling format within 14 days after the letter date. Within that period, it also directed amendments to pending supplemental applications involving labeling changes to incorporate the changes approved in this supplement.

Ryzumvi’s approved uses now include treatment of presbyopia in adults.