- The FDA approved RYZUMVI (phentolamine ophthalmic solution 0.75%) for treating presbyopia in adults on Oct 16, 2026, per Viatris.
- The approval extends Ryzumvi's existing mydriasis indication, which is the only commercially available FDA-approved product for that use.
- Opus Genetics and Viatris hold a global licensing agreement that grants Viatris exclusive U.S. commercialization rights to the product.
- Viatris is exploring a U.S. partner to commercialize Ryzumvi for presbyopia, a point that frames the approval's near-term commercial path.
- Reported presbyopia adverse reactions in more than 5% of subjects were conjunctival hyperemia (21%) and instillation site irritation (16%).
Quotes
“This approval expands the product's indications to include presbyopia.”
“Viatris is exploring the potential for a partner in the United States to commercialize RYZUMVI for the treatment of presbyopia.”