FDA approves Viatris Ryzumvi eye drops for age-related presbyopia in adults
The FDA has approved Viatris' Ryzumvi eye drops for presbyopia in adults, expanding the product's use beyond reversal of pharmacologically induced pupil dilation.
Ryzumvi (phentolamine ophthalmic solution 0.75%) provides a prescription eye-drop treatment option for age-related loss of near focusing ability, offering a non-invasive alternative for eligible adults.
Viatris holds exclusive US commercialisation rights through its agreement with Opus Genetics and is evaluating a potential commercial partner for the newly approved presbyopia indication.
Field | Content |
Article Type | Approvals |
Drug Name | Ryzumvi |
Generic Name | Phentolamine ophthalmic solution |
Strength | 0.75% |
Company | Viatris |
Development and Licensing Partner | Opus Genetics |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | Approval of an expanded indication |
New Indication | Treatment of presbyopia in adults |
Previously Approved Use | Reversal of pharmacologically induced pupil dilation |
Patient Population | Adults with presbyopia |
Therapeutic Area | Ophthalmology; vision correction |
Drug Formulation | Prescription ophthalmic solution |
Treatment Approach | Non-invasive pharmacological treatment using eye drops |
Approval Announcement Date | 16 October 2026 |
Geography | United States |
Commercial Rights | Viatris holds exclusive US commercialisation rights through its agreement with Opus Genetics |
Commercialisation Plans | Viatris is evaluating a potential US commercial partner for the presbyopia indication |
Clinical Evidence | Specific pivotal trial results were not provided in the supplied summary |
What Happened | The FDA approved Ryzumvi phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults. |
Why It Matters | The approval expands the range of prescription eye-drop treatments available for adults experiencing age-related difficulty focusing on nearby objects. |
Supporting Context | Ryzumvi was previously authorised for reversal of pharmacologically induced pupil dilation; the presbyopia indication represents a separate approved use. |
Potential Impact | The expanded indication may create additional treatment and commercial opportunities in the US presbyopia market. |
Key Takeaway | Ryzumvi has received FDA approval for adult presbyopia, expanding its ophthalmic indications and creating a new commercial opportunity for Viatris. |
What to Watch | Commercial partnership announcements, US launch plans, pricing, reimbursement, physician adoption and post-launch performance. |
Primary Source | Viatris |
Primary Source URL | https://newsroom.viatris.com/2026-10-16-Viatris-Receives-U-S-FDA-Approval-for-RYZUMVI-R-for-the-Treatment-of-Presbyopia |
Relevant Date | 16 October 2026 |
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