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Viatris Receives U.S. FDA Approval for RYZUMVI® for the Treatment of Presbyopia

  • The U.S. FDA approved RYZUMVI (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults.
  • This approval expands RYZUMVI's indications to include presbyopia while maintaining its existing approval for pharmacologically-induced mydriasis.
  • Viatris is exploring potential partners in the United States to commercialize RYZUMVI for the treatment of presbyopia.
  • Opus Genetics & Viatris operate under a global licensing agreement granting Viatris exclusive U.S. commercialization rights for the product.
  • Common ocular adverse reactions for presbyopia treatment include conjunctival hyperemia (21%) & instillation site irritation (16%).
  • Common ocular adverse reactions for mydriasis treatment include instillation site discomfort (16%) & conjunctival hyperemia (12%).
  • RYZUMVI is not recommended for patients with active ocular inflammation such as iritis.
  • Contact lens wearers must remove lenses prior to use & wait 10 minutes after dosing before reinserting them.
  • Viatris Inc. is a global healthcare company headquartered in Pittsburgh, with global centers in Shanghai & Hyderabad, India.